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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561741
• Other study ID #: COV15010370
• Status: Completed
• Phase: Phase 1
• First received: September 24, 2015
• Last updated: October 18, 2016
• Start date: December 2012
• Est. completion date: December 2012

Study information

• Verified date: October 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• COV155
COV155 tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC)	To evaluate the effect of food on the pharmacokinetics and bioavailability of COV155 following administration of the formulation given as 3 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions	48 hours	No
Primary	Maximum observed plasma concentration (Cmax)	To evaluate the effect of food on the pharmacokinetics and bioavailability of COV155 following administration of the formulation given as 3 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions	48 hours	No
Primary	Time to achieve the maximum observed plasma concentration (Tmax)	To evaluate the effect of food on the pharmacokinetics and bioavailability of COV155 following administration of the formulation given as 3 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions	48 hours	No