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

NCT02561650 | Completed Phase 1

• 1 other identifier: COV15010196
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

COV155

EXPERIMENTAL

Drug: COV155

Interventions

COV155 DRUG

COV155 tablets

COV155

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• All subjects biologically capable of having children must agree and commit to the use acceptable method(s) of birth control.

You may not qualify if:

• 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.
• History or laboratory evidence of bleeding or clotting disorder or condition.
• History or laboratory evidence of malignancy, stroke, diabetes, cardiac, renal, liver, and chronic pulmonary disease.
• Have or have a history of hay fever or seasonal allergies requiring over-the-counter or prescription medications.

Sponsors & Collaborators

• Mallinckrodt: lead

Related Publications (1)

• 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.

  PMID: 26614499 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: September 28, 2015
• Study Start: December 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 19, 2016

Record last verified: 2016-10