anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Metoprolol
Trial phase: Phase 4
ATC code: C07AB02 | C07BB02 | C07BB52 | C07CB02 | C07FB02 | C07FB13 | C07FX03 | C07FX05
SMILES: COCCc1ccc(OCC(O)CNC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years.
Subjects will be prehypertensive/hypertensive defined as resting systolic blood pressure >125 mmHg and <160 mmHg and/or diastolic >80 mmHg and <100 mmHg.
All of the women in the study will be postmenopausal and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
Candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 1 year prior to the study.

Exclusion Criteria:

Candidates who smoke (currently or in the past 7 years), report more than low-risk alcohol consumption as defined as no more than 14 standard drinks/wk and no more than 4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces of 80-proof distilled spirits).
Potential candidates who are taking cardiovascular-acting (i.e. statins, blood pressure medication and aspirin) medications will not be eligible.
Fasting plasma glucose >126 mg/dL.
Potential candidates with a resting heart rate of < 50 beats/minute will be excluded.
Use of hormone replacement therapy.
In hypertensive subjects, a seated systolic blood pressure >160 mmHg or a seated diastolic blood pressure >100 mmHg will be excluded.
Intervention: Testosterone
Trial phase: Phase 3
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Testosterone: 8 weeks supraphysiologic dose testosterone enanthate
Eligibility criteria:
Inclusion Criteria:

A complete ACL tear as visualized on MRI
The ACL injury can be either "isolated" or combined with one or several of the following injuries visualized on MRI and/or arthroscopy:
a meniscus tear that is either left untreated or treated with a partial resection
a small, stable meniscus tear treated with fixation, but with the fixation not interfering with the rehabilitation protocol
cartilage changes verified on MRI with an arthroscopically determined intact surface.
A radiographic examination with normal joint status or combined with either one of the following findings:
a small-avulsed fragment located laterally, usually described as a Segond fracture, JSN grade 1 or osteophytes grade 1 as determined by the OARSI atlas15

Exclusion Criteria:

Previous major knee injury or knee surgery
Associated posterior cruciate ligament (PCL) or medical collateral ligament (MCL) injury grade III
Concomitant severe injury to contra-lateral knee
Injury to the lateral/posterolateral ligament complex with significantly increased laxity
Unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (we.e. bracing and limited range of motion) interferes with the rehabilitation protocol
Bi-compartmental extensive meniscus resections
Cartilage injury representing a full thickness loss down to bone
Total rupture of MCL/LCL as visualized on MRI.
History of deep vein thrombosis (DVT) or a disorder of the coagulative system
Claustrophobia
Prior or current use of anabolic steroids
General systemic disease affecting physical function
Chromosomal disorders
Medications that interfere with testosterone production or function, including but not limited to 5α-reductase inhibitors
Any other condition or treatment interfering with the completion of the trial
Intervention: Humulin N
Trial phase: Phase 2
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: 20IU Insulin, administered twice per day (40IU total per day)

Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)
Eligibility criteria:
Inclusion Criteria:

Age 50-89
Diagnosed with mild cognitive impairment, or mild/moderate AD

Exclusion Criteria:

Excessively high or low blood pressure, heart rate
Pre-existing diabetes not controlled by exercise/diet
Previous/current use of insulin
Significant elevations in lipids, liver enzymes
Menstrual period within the last 12 months
Significant neurological or medical disorder (other than AD)
Significant use of nasal decongestants
Current use of anti-psychotic, anti-convulsive, anxiolytic, glucocorticoids, or sedative medications
Intervention: Magnesium Sulfate
Trial phase: Not Applicable
ATC code: A06AD04 | A12CC02 | B05XA05 | D11AX05 | V04CC02
SMILES: O=S(=O)([O-])[O-].[Mg+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 261
Group description: Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure

Magnesium Sulfate: 2 grams intravenous drip over 30 minutes
Eligibility criteria:
Inclusion Criteria:

Patient with new onset Atrial fibrillation less than 48 hours after onset undergoing electrical cardioversion.
Patients with atrial fibrillation longer than 48 hours on warfarin with documented therapeutic INR levels >2 for at least 3 weeks prior to the cardioversion, or been on dabigatran for 3 weeks, or a transesophageal echocardiogram on the day of the procedure that excludes intracardiac thrombi, undergoing electrical cardioversion.

Exclusion Criteria:

Creatinine >2.0 mg/dl
Potassium level less than 3.5 mmol/dl
TSH < 0.5
Magnesium levels >3.0 mg/dl
Urgent need for cardioversion (e.g., hemodynamic instability, unstable angina, pulmonary edema)
Patients with recent (less than 6 weeks) acute myocardial infarction
Patients post-cardiac surgery
Pregnant women
Patients who are being treated with antiarrhythmic drugs who have received less than five doses of the drug. For amiodarone, patients who have received less than three weeks prior to cardioversion are excluded.
Intervention: Dronabinol
Trial phase: Phase 4
ATC code: A04AD10
SMILES: [H][C@@]12C=C(C)CC[C@@]1([H])C(C)(C)Oc1cc(CCCCC)cc(O)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Marinol: 5mg BID, orally for 1 month
Eligibility criteria:
Inclusion Criteria:

Male or Female
Ages 18-75 years
Non-GERD related Non cardiac chest pain (Evaluated previously with an EGD, Esophageal manometry, and 24 Hour ambulatory pH study)
At least one episode of chest pain a week in the past month
Previous negative cardiac evaluation (EKG ± Non invasive stress test ± Coronary angiogram)

Exclusion Criteria:

Subjects requiring narcotics or other pain medications
Subjects with known esophagitis, Barrett's esophagus or peptic stricture on endoscopy
Subjects with previous upper gastrointestinal surgery
Pregnancy
Subjects with Diabetes, neuromuscular disorders, or other severe co-morbidities (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric)
Subjects with upper airway symptoms (such as hoarseness, wheezing or laryngospasm)
Medications such as baclofen, H2 blockers, PPI, sucralfate and prokinetics.
Known history of substance abuse
Nursing mothers
Intervention: Vancomycin
Trial phase: Phase 3
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 301
Group description: Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
Eligibility criteria:
Inclusion Criteria:

Is able to read and sign a consent form;
Is from ≥18 to <90 years of age;
Has diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device;
Tests positive for Clostridium difficile;
If female, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study.

Exclusion Criteria:

Has toxic megacolon and/or known small bowel ileus;
Has received treatment with intravenous immune globulin (IVIG) within the past 30 days;
Has received treatment with a fecal transplant within 7 days, and/or if the doctor anticipates to give the participant a fecal transplant during the study;
Has received a certain amount of antibacterial therapy specific for current CDAD, unless it is not working;
Has received an investigational vaccine against Clostridium difficile;
Has received an investigational product containing monoclonal antibodies against toxin A or B within 180 days;
Has more than 2 episodes of CDAD within 90 days;
Has had major gastrointestinal (GI) surgery (i.e. significant bowel resection) within 3 months (this does not include appendectomy or cholecystectomy);
Has a history of prior inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis;
Is unable to discontinue loperamide, diphenoxylate/atropine, or cholestyramine during the duration of the study;
Is unable to discontinue opiate treatment unless on a stable dose;
Has known positive stool cultures for other enteropathogens including but not limited to Salmonella, Shigella, and Campylobacter;
Has had stool studies positive for pathogenic ova and/or parasites;
Has an intolerance or hypersensitivity to daptomycin and/or vancomycin;
Has a life-threatening illness at the time of enrollment;
Has poor concurrent medical risks that in the opinion of the Investigator the participant should not enroll;
Has received an investigational drug or participated in any experimental procedure within 1 month;
Has human immunodeficiency virus (HIV), a cluster of differentiation (CD) 4 count <200 cells/mm^3 within 6 months of start of study therapy;
Anticipates that certain antibacterial therapy for a non-CDAD infection will be required for >7 days;
Is unable to discontinue Saccharomyces or similar probiotic;
Is on a concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy;
Is unable to comply with the protocol requirements;
Has any condition that, in the opinion of the Investigator, might interfere;
Is not expected to live for less than 8 weeks.
Intervention: Hydromorphone
Trial phase: Phase 2
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Laboring patients receive ED50 of hydromorphone one time intrathecally.

ED50 of hydromorphone was 12.7 mcg +/- 3.27.
Eligibility criteria:
Inclusion Criteria:

Healthy patients
Labor
Desires pain relief

Exclusion Criteria:

Any comorbidities other than obesity
Intervention: Hydromorphone
Trial phase: Phase 2
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Laboring patients receive ED50 of hydromorphone one time intrathecally

Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.

ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg.
Eligibility criteria:
Inclusion Criteria:

Healthy women undergoing cesarean section

Exclusion Criteria:

Any comorbidities other than obesity, hypertension, fetal anomalies
Intervention: Axitinib
Trial phase: Phase 3
ATC code: L01EK01 | L01XE17
SMILES: CNC(=O)c1ccccc1Sc1ccc2c(/C=C/c3ccccn3)n[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 360
Group description: Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Eligibility criteria:
Inclusion Criteria:

Patients must be treated by nephrectomy and patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

Patients must have no evidence of macroscopic residual disease or metastatic disease.
Male or female, age >=18 years (age >=20 years in Japan, Korea and Taiwan).

Patients must be diagnosed with one of the following based on American Joint Committee on Cancer (AJCC) TNM staging version 2010, Eastern Collaborative Oncology Group (ECOG) performance status (PS):

pT2, pN0 or pNx, M0 and ECOG PS 0-1
pT3, pN0 or pNx, M0 and ECOG PS 0-1
pT4, pN0 or pNx, M0 and ECOG PS 0-1
Any pT, pN1, M0 and ECOG PS 0-1
Patients must have histologically confirmed preponderant, defined as >50%, clear cell RCC.
Patients must not have received any previous systemic (includes chemotherapeutic, hormonal, or immunotherapeutic) treatment for RCC.
Patients must not have received any previous anti angiogenic treatment.
Patients must have adequate organ function.

Exclusion Criteria

Histologically undifferentiated carcinomas, sarcomas, collecting duct carcinoma, lymphoma, or patients with any metastatic renal sites.
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hemorrhage <4 weeks of date of randomization.
Diagnosis of any non-RCC malignancy within the 5 years from date of randomization, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months.
Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
Gastrointestinal abnormalities
Intervention: Cabozantinib
Trial phase: Phase 2
ATC code: L01EX07 | L01XE26
SMILES: COc1cc2nccc(Oc3ccc(NC(=O)C4(C(=O)Nc5ccc(F)cc5)CC4)cc3)c2cc1OC
Sex: Male
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.

cabozantinib: Given PO

laboratory biomarker analysis: Correlative studies

magnetic resonance imaging: Undergo MRI
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed prostate cancer with progressive disease
Evidence of castration resistance defined as disease progression despite a testosterone level < 50ng/dL (or surgical castration)
Evidence of metastatic disease to the bones within the lumbar spine, sacrum, or pelvic bones that is identifiable on screening pelvic MRI
If patient has had prior pelvis radiation therapy (RT), then bone metastases must be out of radiated port (e.g. lumbar or sacral spine)
Any prior therapy for castrate disease acceptable other than prior XL184 with a minimum washout of 28 days for any other anticancer therapy

Patients with castrate resistant disease post antiandrogen therapy/withdrawal must meet at least one of the following criteria:

Have not received docetaxel chemotherapy
Have received docetaxel chemotherapy but received less then 225mg/m2 cumulative dose
Have documented liver metastases
Have no pain or pain that does not require a long acting (SR) narcotic
Have received mitoxantrone chemotherapy in the past for CRPC

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
Patients who are receiving any other investigational agents
Prior treatment with other vascular endothelial growth factor (VEGF) or c-MET targeted therapies
History of hematemesis or hemoptysis
The subject has uncontrolled or significant intercurrent illness
The patient requires concomitant treatment, in therapeutic doses, with anticoagulants
Intervention: Atorvastatin
Trial phase: Phase 4
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Participants were given Atorvastatin for 12 weeks based on HAART

Subjects on PI based HAART regimen were administered atorvastatin at 10mg/day X 2weeks and then 20mg/day for 10 weeks.
Subjects on non-PI / non-NNRTI based HAART regimen were administered 20mg/day X 2weeks and then 40mg/day X 10weeks.
Subjects on NNRTI based HAART regimen were administered 40mg/day X 2weeks and then 80mg/day X 10weeks.
Eligibility criteria:
Inclusion Criteria:

Chronic HIV-1 infected individuals on HAART (with no change in treatment within 4 weeks of study entry) and willing to continue therapy for the duration of the study.
HIV viral load less than 200 copies/ml for more than 6 months at time of screening.
Nadir CD4 count less than 350 and current CD4 counts greater than 100 cells/ul.
Hs-CRP levels above 2mg/L.
Willingness to use a method of contraception during the study period.
Willingness to comply with study evaluations for LP sub-study.
Karnofsky performance score of 80 or higher.
If female, willing to undergo pregnancy testing on a monthly basis and not breastfeeding.
Hemoglobin greater than or equal to 9.0 g/dL for female and 10.0 g/dL for male subjects.
men and women 18 years or older.

Exclusion Criteria:

Concomitant use of fibric acid derivatives or other lipid lowering agents including patients on statins and Ezetimibe.
Use of any anti-inflammatory drugs (OTC or prescription) on a daily basis.
Pregnancy or breastfeeding
Active drug use or alcohol abuse/dependence which in the opinion of researchers will interfere with the patients' ability to participate in the study.
Allergy or hypersensitivity to Atorvastatin or any of its components.
History of myositis or rhabdomyolysis with use of any statins.
Patients who are on concurrent immunomodulatory agents, including systemic corticosteroids (nasal or inhaled) will be ineligible for 3 months after completion of therapy with the agent.
History of inflammatory muscle disease such a poly or dermatomyositis.
Serious intercurrent illness requiring systemic treatment and/or hospitalization within 30 days of entry.
Evidence of active opportunistic infections requiring treatment or neoplasms that require chemotherapy during study period.
CPK greater than 3 times the ULN.
Known active liver disease or AST/ALT greater than 3 times the ULN.
Renal insufficiency, indicated by serum creatinine greater than 2mg/dL.
Absolute neutrophil counts less than 1000/ul; hemoglobin less than 10g/dL for males and less than 9g/dL for females; platelet counts less than 100,000/mm3.
Documented HCV infection.
NYHA class III or IV congestive heart failure.
Active IV drug use within 1 year prior to entry.
For LP sub-study, allergy to Lidocaine.
Coronary artery disease or equivalent including Diabetes mellitus.
Intervention: Sitagliptin
Trial phase: Phase 2 | Phase 3
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: sitagliptin, 100mg, oral, single dose
Eligibility criteria:
Inclusion Criteria:

Men and women, aged 18 to 60 years
Body mass index 20 kg/m2 to 27 kg/m2
Hemoglobin above 130g/L.
Normal glucose tolerance in response to a 75g, 2-hr OGTT

Exclusion Criteria:

Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr > 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP > 100 or systolic > 180) or proliferative retinopathy
History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.
Any history of a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.
Any laboratory values: AST > 2x ULN; ALT > 2x ULN TSH > 6 mU/l
Current addiction to alcohol or substances of abuse as determined by the investigator.
Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
Taking any prescription or non-prescription medications at the time of the study
Having donated blood three months prior to and three months post study procedures
A pregnancy test will be performed 1 to 3 days prior to each study in all female subjects. Those who test positive for pregnancy will be excluded.
Intervention: Theophylline
Trial phase: Phase 4
ATC code: R03DA04 | R03DA20 | R03DA54 | R03DA74 | R03DB04
SMILES: Cn1c(=O)c2[nH]cnc2n(C)c1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Theophylline 300 mg, solution, orally, on Day 1, followed by a 4-day washout period.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-45 years of age, non smoking and non-pregnant (postmenopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive; hemoglobin greater than or equal to 11.5g/dL

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation or donation of plasma
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
Subjects who test positive for drugs of abuse or alcohol at screening or check-in
History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease or active sexually transmitted disease
History of neuropathy or muscle disorders, peptic ulcer disease, clinically significant cardiac arrhythmias, seizure disorder, and low white blood cell count or other bone marrow disorders
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
History of allergy or sensitivity to colchicine or theophylline or aminophylline
Subjects who have had a tattoo or body piercing within 30 days prior to administration of study drug
Subjects with irritable bowel syndrome, chronic diarrhea or other chronic gastro-intestinal problems
Subjects who are lactose intolerant