anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cobitolimod
Trial phase: Phase 2
SMILES: Cc1cn(C2CC(OP(=O)(O)OCC3OC(n4ccc(N)nc4=O)CC3OP(=O)(O)OCC3OC(n4cnc5c(=O)[nH]c(N)nc54)CC3OP(=O)(O)OCC3OC(n4cc(C)c(=O)[nH]c4=O)CC3OP(=O)(O)OCC3OC(n4ccc(N)nc4=O)CC3OP(=O)(O)OCC3OC(n4ccc(N)nc4=O)CC3OP(=O)(O)OCC3OC(n4cnc5c(N)ncnc54)CC3OP(=O)(O)OCC3OC(n4cc(C)c(=O)[nH]c4=O)CC3OP(O)(=S)OCC3OC(n4cnc5c(=O)[nH]c(N)nc54)CC3OP(O)(=S)OCC3OC(n4cnc5c(=O)[nH]c(N)nc54)CC3OP(O)(=S)OCC3OC(n4ccc(N)nc4=O)CC3O)C(COP(=O)(O)OC3CC(n4cc(C)c(=O)[nH]c4=O)OC3COP(=O)(O)OC3CC(n4cnc5c(=O)[nH]c(N)nc54)OC3COP(=O)(O)OC3CC(n4cnc5c(N)ncnc54)OC3COP(=O)(O)OC3CC(n4ccc(N)nc4=O)OC3COP(=O)(O)OC3CC(n4cnc5c(N)ncnc54)OC3COP(O)(=S)OC3CC(n4cnc5c(N)ncnc54)OC3COP(O)(=S)OC3CC(n4cnc5c(=O)[nH]c(N)nc54)OC3COP(O)(=S)OC3CC(n4cnc5c(=O)[nH]c(N)nc54)OC3CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions

cobitolimod: Rectal administration
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years old
Established diagnosis of Ulcerative Colitis (UC)
Moderately to severely active left sided UC assessed by central reading
Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use
Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance

Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents:

Immunomodulators
Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins

Exclusion Criteria:

Suspicion of differential diagnosis
Acute fulminant UC and/or signs of systemic toxicity
UC limited to the rectum (disease which extend <15 cm above the anal verge)
History of malignancy
History or presence of any clinically significant disorder
Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators
Treatment with rectal GCS, 5-ASA/SP or tacrolimus
Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs)
Serious active infection
Gastrointestinal infections
Currently receiving parenteral nutrition or blood transfusions
Females who are lactating or have a positive serum pregnancy test
Women of childbearing potential not using reliable contraceptive methods
Concurrent participation in another clinical study
Previous exposure to cobitolimod
Intervention: Cobitolimod
Trial phase: Phase 2
SMILES: Cc1cn(C2CC(OP(=O)(O)OCC3OC(n4ccc(N)nc4=O)CC3OP(=O)(O)OCC3OC(n4cnc5c(=O)[nH]c(N)nc54)CC3OP(=O)(O)OCC3OC(n4cc(C)c(=O)[nH]c4=O)CC3OP(=O)(O)OCC3OC(n4ccc(N)nc4=O)CC3OP(=O)(O)OCC3OC(n4ccc(N)nc4=O)CC3OP(=O)(O)OCC3OC(n4cnc5c(N)ncnc54)CC3OP(=O)(O)OCC3OC(n4cc(C)c(=O)[nH]c4=O)CC3OP(O)(=S)OCC3OC(n4cnc5c(=O)[nH]c(N)nc54)CC3OP(O)(=S)OCC3OC(n4cnc5c(=O)[nH]c(N)nc54)CC3OP(O)(=S)OCC3OC(n4ccc(N)nc4=O)CC3O)C(COP(=O)(O)OC3CC(n4cc(C)c(=O)[nH]c4=O)OC3COP(=O)(O)OC3CC(n4cnc5c(=O)[nH]c(N)nc54)OC3COP(=O)(O)OC3CC(n4cnc5c(N)ncnc54)OC3COP(=O)(O)OC3CC(n4ccc(N)nc4=O)OC3COP(=O)(O)OC3CC(n4cnc5c(N)ncnc54)OC3COP(O)(=S)OC3CC(n4cnc5c(N)ncnc54)OC3COP(O)(=S)OC3CC(n4cnc5c(=O)[nH]c(N)nc54)OC3COP(O)(=S)OC3CC(n4cnc5c(=O)[nH]c(N)nc54)OC3CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions

cobitolimod: Rectal administration
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years old
Established diagnosis of Ulcerative Colitis (UC)
Moderately to severely active left sided UC assessed by central reading
Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use
Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance

Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents:

Immunomodulators
Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins

Exclusion Criteria:

Suspicion of differential diagnosis
Acute fulminant UC and/or signs of systemic toxicity
UC limited to the rectum (disease which extend <15 cm above the anal verge)
History of malignancy
History or presence of any clinically significant disorder
Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators
Treatment with rectal GCS, 5-ASA/SP or tacrolimus
Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs)
Serious active infection
Gastrointestinal infections
Currently receiving parenteral nutrition or blood transfusions
Females who are lactating or have a positive serum pregnancy test
Women of childbearing potential not using reliable contraceptive methods
Concurrent participation in another clinical study
Previous exposure to cobitolimod
Intervention: Cobitolimod
Trial phase: Phase 2
SMILES: Cc1cn(C2CC(OP(=O)(O)OCC3OC(n4ccc(N)nc4=O)CC3OP(=O)(O)OCC3OC(n4cnc5c(=O)[nH]c(N)nc54)CC3OP(=O)(O)OCC3OC(n4cc(C)c(=O)[nH]c4=O)CC3OP(=O)(O)OCC3OC(n4ccc(N)nc4=O)CC3OP(=O)(O)OCC3OC(n4ccc(N)nc4=O)CC3OP(=O)(O)OCC3OC(n4cnc5c(N)ncnc54)CC3OP(=O)(O)OCC3OC(n4cc(C)c(=O)[nH]c4=O)CC3OP(O)(=S)OCC3OC(n4cnc5c(=O)[nH]c(N)nc54)CC3OP(O)(=S)OCC3OC(n4cnc5c(=O)[nH]c(N)nc54)CC3OP(O)(=S)OCC3OC(n4ccc(N)nc4=O)CC3O)C(COP(=O)(O)OC3CC(n4cc(C)c(=O)[nH]c4=O)OC3COP(=O)(O)OC3CC(n4cnc5c(=O)[nH]c(N)nc54)OC3COP(=O)(O)OC3CC(n4cnc5c(N)ncnc54)OC3COP(=O)(O)OC3CC(n4ccc(N)nc4=O)OC3COP(=O)(O)OC3CC(n4cnc5c(N)ncnc54)OC3COP(O)(=S)OC3CC(n4cnc5c(N)ncnc54)OC3COP(O)(=S)OC3CC(n4cnc5c(=O)[nH]c(N)nc54)OC3COP(O)(=S)OC3CC(n4cnc5c(=O)[nH]c(N)nc54)OC3CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions

cobitolimod: Rectal administration
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years old
Established diagnosis of Ulcerative Colitis (UC)
Moderately to severely active left sided UC assessed by central reading
Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use
Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance

Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents:

Immunomodulators
Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins

Exclusion Criteria:

Suspicion of differential diagnosis
Acute fulminant UC and/or signs of systemic toxicity
UC limited to the rectum (disease which extend <15 cm above the anal verge)
History of malignancy
History or presence of any clinically significant disorder
Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators
Treatment with rectal GCS, 5-ASA/SP or tacrolimus
Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs)
Serious active infection
Gastrointestinal infections
Currently receiving parenteral nutrition or blood transfusions
Females who are lactating or have a positive serum pregnancy test
Women of childbearing potential not using reliable contraceptive methods
Concurrent participation in another clinical study
Previous exposure to cobitolimod
Intervention: Cobitolimod
Trial phase: Phase 2
SMILES: Cc1cn(C2CC(OP(=O)(O)OCC3OC(n4ccc(N)nc4=O)CC3OP(=O)(O)OCC3OC(n4cnc5c(=O)[nH]c(N)nc54)CC3OP(=O)(O)OCC3OC(n4cc(C)c(=O)[nH]c4=O)CC3OP(=O)(O)OCC3OC(n4ccc(N)nc4=O)CC3OP(=O)(O)OCC3OC(n4ccc(N)nc4=O)CC3OP(=O)(O)OCC3OC(n4cnc5c(N)ncnc54)CC3OP(=O)(O)OCC3OC(n4cc(C)c(=O)[nH]c4=O)CC3OP(O)(=S)OCC3OC(n4cnc5c(=O)[nH]c(N)nc54)CC3OP(O)(=S)OCC3OC(n4cnc5c(=O)[nH]c(N)nc54)CC3OP(O)(=S)OCC3OC(n4ccc(N)nc4=O)CC3O)C(COP(=O)(O)OC3CC(n4cc(C)c(=O)[nH]c4=O)OC3COP(=O)(O)OC3CC(n4cnc5c(=O)[nH]c(N)nc54)OC3COP(=O)(O)OC3CC(n4cnc5c(N)ncnc54)OC3COP(=O)(O)OC3CC(n4ccc(N)nc4=O)OC3COP(=O)(O)OC3CC(n4cnc5c(N)ncnc54)OC3COP(O)(=S)OC3CC(n4cnc5c(N)ncnc54)OC3COP(O)(=S)OC3CC(n4cnc5c(=O)[nH]c(N)nc54)OC3COP(O)(=S)OC3CC(n4cnc5c(=O)[nH]c(N)nc54)OC3CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Dose 125 mg of cobitolimod, at 4 occasions

cobitolimod: Rectal administration
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years old
Established diagnosis of Ulcerative Colitis (UC)
Moderately to severely active left sided UC assessed by central reading
Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use
Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance

Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents:

Immunomodulators
Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins

Exclusion Criteria:

Suspicion of differential diagnosis
Acute fulminant UC and/or signs of systemic toxicity
UC limited to the rectum (disease which extend <15 cm above the anal verge)
History of malignancy
History or presence of any clinically significant disorder
Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators
Treatment with rectal GCS, 5-ASA/SP or tacrolimus
Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs)
Serious active infection
Gastrointestinal infections
Currently receiving parenteral nutrition or blood transfusions
Females who are lactating or have a positive serum pregnancy test
Women of childbearing potential not using reliable contraceptive methods
Concurrent participation in another clinical study
Previous exposure to cobitolimod
Intervention: Gabapentin
Trial phase: Phase 4
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 28
Group description: Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
Eligibility criteria:
Inclusion Criteria:

Between 40 and 80 years of age, inclusive.
Body weight > 50 kg and BMI between 18 and 32 kg/m2, inclusive.
Able to give informed consent.
Licensed, experienced driver who had driven at least 3 times a week for the past 3 years and had visual acuity adequate for driving, as assessed by the investigator or designee.
Able to complete a 1 hour simulated driving test and demonstrate satisfactory driving skills, as determined by the investigator or designee.
Karolinska Sleep Scale (KSS) score of <=5.
Other criteria apply.

Exclusion Criteria:

Known history of allergic reaction, hypersensitivity or clinically significant intolerance to gabapentin, pregabalin or any pharmaceutical materials, or any of the ingredients in the protocol-specified meals.
Pregnant or lactating or considered at risk of pregnancy.
Any medical condition or any laboratory abnormality or ECG abnormality that would, in the opinion of the investigator, contraindicate study participation.
Impaired liver function (e.g., alanine aminotransferase [ALT] ≥2 times the upper limit of normal [ULN] or bilirubin ≥2 times ULN), known active hepatic disease (e.g., hepatitis), or evidence of clinically significant liver disease or other condition affecting the liver that may suggest the potential for an increased susceptibility to hepatic toxicity with oral gabapentin or pregabalin exposure.
Any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject had significantly impaired renal function as evidenced by an estimated GFR of ≤ 80 ml/min/1.73m2.
History or evidence of a sleep disorder, including sleep apnea (obstructive, central or mixed), narcolepsy or primary insomnia.
Other criteria apply.
Intervention: Gabapentin
Trial phase: Phase 4
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 31
Group description: Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
Eligibility criteria:
Inclusion Criteria:

Between 40 and 80 years of age, inclusive.
Body weight > 50 kg and BMI between 18 and 32 kg/m2, inclusive.
Able to give informed consent.
Licensed, experienced driver who had driven at least 3 times a week for the past 3 years and had visual acuity adequate for driving, as assessed by the investigator or designee.
Able to complete a 1 hour simulated driving test and demonstrate satisfactory driving skills, as determined by the investigator or designee.
Karolinska Sleep Scale (KSS) score of <=5.
Other criteria apply.

Exclusion Criteria:

Known history of allergic reaction, hypersensitivity or clinically significant intolerance to gabapentin, pregabalin or any pharmaceutical materials, or any of the ingredients in the protocol-specified meals.
Pregnant or lactating or considered at risk of pregnancy.
Any medical condition or any laboratory abnormality or ECG abnormality that would, in the opinion of the investigator, contraindicate study participation.
Impaired liver function (e.g., alanine aminotransferase [ALT] ≥2 times the upper limit of normal [ULN] or bilirubin ≥2 times ULN), known active hepatic disease (e.g., hepatitis), or evidence of clinically significant liver disease or other condition affecting the liver that may suggest the potential for an increased susceptibility to hepatic toxicity with oral gabapentin or pregabalin exposure.
Any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject had significantly impaired renal function as evidenced by an estimated GFR of ≤ 80 ml/min/1.73m2.
History or evidence of a sleep disorder, including sleep apnea (obstructive, central or mixed), narcolepsy or primary insomnia.
Other criteria apply.
Intervention: Pregabalin
Trial phase: Phase 4
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 31
Group description: Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
Eligibility criteria:
Inclusion Criteria:

Between 40 and 80 years of age, inclusive.
Body weight > 50 kg and BMI between 18 and 32 kg/m2, inclusive.
Able to give informed consent.
Licensed, experienced driver who had driven at least 3 times a week for the past 3 years and had visual acuity adequate for driving, as assessed by the investigator or designee.
Able to complete a 1 hour simulated driving test and demonstrate satisfactory driving skills, as determined by the investigator or designee.
Karolinska Sleep Scale (KSS) score of <=5.
Other criteria apply.

Exclusion Criteria:

Known history of allergic reaction, hypersensitivity or clinically significant intolerance to gabapentin, pregabalin or any pharmaceutical materials, or any of the ingredients in the protocol-specified meals.
Pregnant or lactating or considered at risk of pregnancy.
Any medical condition or any laboratory abnormality or ECG abnormality that would, in the opinion of the investigator, contraindicate study participation.
Impaired liver function (e.g., alanine aminotransferase [ALT] ≥2 times the upper limit of normal [ULN] or bilirubin ≥2 times ULN), known active hepatic disease (e.g., hepatitis), or evidence of clinically significant liver disease or other condition affecting the liver that may suggest the potential for an increased susceptibility to hepatic toxicity with oral gabapentin or pregabalin exposure.
Any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject had significantly impaired renal function as evidenced by an estimated GFR of ≤ 80 ml/min/1.73m2.
History or evidence of a sleep disorder, including sleep apnea (obstructive, central or mixed), narcolepsy or primary insomnia.
Other criteria apply.
Intervention: Remetinostat
Trial phase: Phase 2
SMILES: COC(=O)c1ccc(OC(=O)CCCCCCC(=O)NO)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Patients receive topical remetinostat 1% gel applied TID directly to the lesion, for 6 weeks in the absence of disease progression or unacceptable toxicity.

Remetinostat: Applied topically under bandage occlusion
Eligibility criteria:
Inclusion Criteria:

Must have at least one BCC lesion > 1 cm (BCC > 5 mm) in non-cosmetically sensitive site(s)
Must be willing to apply the topical remetinostat 3 times daily for 6 weeks
For women of child bearing potential, a negative urine pregnancy test
Women of child bearing potential are expected to use an effective method of birth control while participating in the study and for 1 month after applying the last dose
For male subjects with female partners of childbearing potential, agreement to use adequate contraception while participating in the study and for 1 month after applying the last dose
Has signed and dated the current Institutional Review Board (IRB) approved informed consent document

Exclusion Criteria:

Taking any medication known to interact with histone deacetylase (HDAC) inhibitors, such as valproate or anticoagulants
Taking any medication known to affect hedgehog (HH) signaling pathway such as itraconazole

Within the past 6 months, has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically, these include the topical use to the study tumors of:

Glucocorticoids
Retinoids either systemically or topically (eg, etretinate, isotretinoin, tazarotene, tretinoin, adapalene)
Alpha hydroxy acids (eg, glycolic acid, lactic acid) to > 5% of the skin
5 fluorouracil or imiquimod and/or
Itraconazole
Has received treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling, within 60 days to starting study medication
Currently receiving systemic medications that could affect BCC tumors (eg, oral retinoids) or might interact with remetinostat
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, recurrent seizure history or psychiatric illness/social situations that would limit compliance with study requirements
Moderate to severe immunosuppression due to disease or medication
Known or previous hypersensitivity to histone deacetylase inhibitor (HDACi)
History of congestive heart failure; cardiac arrhythmias; or other findings of ventricular dysfunction
History of current evidence of malabsorption or liver disease
Pregnancy or breast feeding
Intervention: Tranexamic acid
Trial phase: Phase 2
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Subjects will be treated with early administration of TXA in the Emergency Department

Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours
Eligibility criteria:
Inclusion Criteria:

AO/OTA fracture classification 31A
Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
Low energy, isolated injury

Exclusion Criteria:

Intracapsular hip fractures: AO/OTA fracture classification 31B-C
Polytrauma patients
Creatinine clearance less than 30 mL/min
History of unprovoked VTE and/or recurrent VTE
Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
History of CVA, MI, or VTE within the previous 30 days
Coronary stent placement within the previous 6 months
Disseminated intravascular coagulation
Intracranial hemorrhage
Intervention: Lasmiditan
Trial phase: Phase 1
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: 200 mg lasmiditan on Day 1 of 1 of 2 dosing periods.
Eligibility criteria:
Inclusion Criteria:

Are overtly healthy males or females, as determined by medical history and physical examination.
Have a body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²) inclusive, at the time of screening.

Exclusion Criteria:

Have known allergies to lasmiditan, related compounds or any components of the formulation.
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.
Show evidence of active renal disease or estimated glomerular filtration rate (eGFR) less than 60 milliliter per minute (mL/min) per 1.73 m².
Show evidence of or positive serology for human immunodeficiency virus (HIV) infection, hepatitis B or C.
Are women with a positive pregnancy test or women who are lactating.
Have a clinically significant abnormality in the neurological examination.
Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator.
Have orthostatic hypotension with or without dizziness and/or syncope at screening or Day -1 upon repeat testing, or a history of it.
Intervention: Lasmiditan
Trial phase: Phase 1
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: 200 mg of lasmiditan on Day 1.
Eligibility criteria:
Inclusion Criteria:

Are overtly healthy males or females, as determined by medical history and physical examination.
Have a body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²) inclusive, at the time of screening.

Exclusion Criteria:

Have known allergies to lasmiditan, related compounds or any components of the formulation.
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.
Show evidence of active renal disease or estimated glomerular filtration rate (eGFR) less than 60 milliliter per minute (mL/min) per 1.73 m².
Show evidence of or positive serology for human immunodeficiency virus (HIV) infection, hepatitis B or C.
Are women with a positive pregnancy test or women who are lactating.
Have a clinically significant abnormality in the neurological examination.
Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator.
Have orthostatic hypotension with or without dizziness and/or syncope at screening or Day -1 upon repeat testing, or a history of it.