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

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

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: COV155

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COV155	Drug: COV155; COV155 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 2 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions	48 hours
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 2 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions	48 hours
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 2 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions	48 hours

Collaborators and Investigators

• Sponsor: Mallinckrodt

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 24, 2015
• First Submitted That Met QC Criteria: September 25, 2015
• First Posted (Estimate): September 28, 2015

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: COV15010196