Pharmacokinetic, Bioavailability, and Safety Study of COV155 Administered in Healthy Subjects Under Fed and Fasted Conditions

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: COV155

• Registration Number: NCT02561650
• Lead Sponsor: Mallinckrodt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-25
• Study First Posted: 2015-09-28
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COV155	COV155	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve (AUC)	48 hours	To evaluate the effect of food on the pharmacokinetics and bioavailability of COV155 following administration of the formulation given as 2 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions
Maximum observed plasma concentration (Cmax)	48 hours	To evaluate the effect of food on the pharmacokinetics and bioavailability of COV155 following administration of the formulation given as 2 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions
Time to achieve the maximum observed plasma concentration (Tmax)	48 hours	To evaluate the effect of food on the pharmacokinetics and bioavailability of COV155 following administration of the formulation given as 2 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions