Clinical trial NCT02561741: Pharmacokinetic, Bioavailability, and Safety Study of COV155 Administered in Healthy Subjects Under Fed and Fasted Conditions
Official title: An Open-Label, Randomized, Single-Dose, Three-Period Crossover Study to Evaluate the Pharmacokinetics, Bioavailability, and Safety of 3 Tablets of COV155 Administered in Normal, Healthy Subjects Under Fed (High- and Low-Fat Meal) and Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2015-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A single center, single dose, open-label, randomized, 3-period, 6-sequence, crossover study conducted in normal healthy subjects to evaluate the effect of a high- and low-fat meal on the pharmacokinetics (PK), bioavailability (BA), and safety of COV155.


Eligibility criteria: Inclusion Criteria:

1. Males and/or non-pregnant, non-lactating or postmenopausal females, between 18 and 55 years of age with a body mass index ≥ 19 and ≤ 30 kg/m2.
2. All subjects biologically capable of having children must agree and commit to the use acceptable method(s) of birth control.

Exclusion Criteria:

1. ECG abnormalities or lab values greater than 2 times the upper limit of normal.
2. Positive test results for human immunodeficiency virus (HIV), hepatitis B (HBsAg), or hepatitis C (IgG).
3. Positive urine test results for drugs of abuse or history of drug/alcohol abuse.
4. Use of marijuana, illicit drugs or nicotine-containing products.
5. Donated or had significant loss of whole blood.
6. Taken any prescription or nonprescription drugs, vitamins, minerals, or dietary/herbal supplements.
7. History of abdominal and/or pelvic surgery, cholecystectomy, gastric bypass or gastric band surgery, or cardiothoracic surgery.
8. History of anxiety, tension, agitation, psychiatric disorders, psychosis, or depression requiring hospitalization, psychotherapy, and/or medication.
9. History of acute or chronic gastrointestinal disease or any condition that may interfere with the absorption, distribution, metabolism or excretion of the study treatment.
10. History of seizures or diagnosis of epilepsy or other seizure disorder.
11. History or laboratory evidence of bleeding or clotting disorder or condition.
12. History or laboratory evidence of malignancy, stroke, diabetes, cardiac, renal, liver, and chronic pulmonary disease.
13. Have or have a history of hay fever or seasonal allergies requiring over-the-counter or prescription medications.

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: 48 hours
measure: Maximum observed plasma concentration (Cmax)
timeFrame: 48 hours
measure: Time to achieve the maximum observed plasma concentration (Tmax)
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Devarakonda K, Kostenbader K, Giuliani MJ, Young JL. Single-dose pharmacokinetics of 2 or 3 tablets of biphasic immediate-release/extended-release hydrocodone bitartrate/acetaminophen (MNK-155) under fed and fasted conditions: two randomized open-label trials. BMC Pharmacol Toxicol. 2015 Nov 27;16:31. doi: 10.1186/s40360-015-0032-y.