An Open-Label, Randomized, Single-Dose, Three-Period Crossover Study to Evaluate the Pharmacokinetics, Bioavailability, and Safety of COV155 Administered in Normal, Healthy Subjects Under Fed (High- and Low-Fat Meal) and Fasted Conditions
Overview
- Phase
- Phase 1
- Intervention
- COV155
- Conditions
- Pharmacokinetics
- Sponsor
- Mallinckrodt
- Enrollment
- 48
- Primary Endpoint
- Area under the plasma concentration-time curve (AUC)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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/m
- •All subjects biologically capable of having children must agree and commit to the use acceptable method(s) of birth control.
Exclusion Criteria
- •ECG abnormalities or lab values greater than 2 times the upper limit of normal.
- •Positive test results for human immunodeficiency virus (HIV), hepatitis B (HBsAg), or hepatitis C (IgG).
- •Positive urine test results for drugs of abuse or history of drug/alcohol abuse.
- •Use of marijuana, illicit drugs or nicotine-containing products.
- •Donated or had significant loss of whole blood.
- •Taken any prescription or nonprescription drugs, vitamins, minerals, or dietary/herbal supplements.
- •History of abdominal and/or pelvic surgery, cholecystectomy, gastric bypass or gastric band surgery, or cardiothoracic surgery.
- •History of anxiety, tension, agitation, psychiatric disorders, psychosis, or depression requiring hospitalization, psychotherapy, and/or medication.
- •History of acute or chronic gastrointestinal disease or any condition that may interfere with the absorption, distribution, metabolism or excretion of the study treatment.
- •History of seizures or diagnosis of epilepsy or other seizure disorder.
Arms & Interventions
COV155
Intervention: COV155
Outcomes
Primary Outcomes
Area under the plasma concentration-time curve (AUC)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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