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Completed

NCT Number: NCT02561650

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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/m2.
  • 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.
  • 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.

Treatment and study plan

COV155

Drug

COV155 tablets

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 28, 2015
Registry last updated
Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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