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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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COV155

Group Type EXPERIMENTAL

COV155

Intervention Type DRUG

COV155 tablets

Interventions

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COV155

COV155 tablets

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes