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Completed

NCT Number: NCT01349725

A Safety Study of ARRY-502 in Healthy Subjects

This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects from the United States will be enrolled in this study.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Madison, Wisconsin, United States

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Healthy male or female between the ages of 18 and 50 years.
  • Females must be of nonchildbearing potential.
  • Body mass index (BMI) of 18 to 32 and a total body weight > 50 kg (110 lbs) and < 114 kg (250 lbs).
  • Additional criteria exist.

Key Exclusion Criteria:

  • Evidence or history of clinically significant disease (excepting allergic rhinitis).
  • Evidence of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
  • Gastrointestinal surgery that may interfere with motility or absorption.
  • Serious illness requiring hospitalization within the previous 6 months.
  • A positive test for drugs or alcohol.
  • Recent use of tobacco- or nicotine-containing products. Use of any medications, grapefruit or supplements within the previous 14 days.
  • Use of corticosteroids within the previous 28 days.
  • Recent history of blood, plasma or platelet donation.
  • Treatment with a small-molecule investigational drug within the previous 30 days or any biologic therapy within the previous 6 months.
  • Prior exposure to investigational study drug ARRY-502.
  • Additional criteria exist.

Treatment and study plan

ARRY-502

Drug

Oral; multiple dose, escalating

Placebo

Drug

Oral; matching placebo

Primary outcomes

  1. Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests, electrocardiograms and vital signs.

    Time frame: 3 weeks

  2. Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.

    Time frame: 2 weeks

Secondary outcomes

  1. Characterize the pharmacodynamics of the study drug as determined by laboratory assays.

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 9, 2011
Registry last updated
Oct 5, 2020

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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