A Safety Study of ARRY-502 in Healthy Subjects

Array BioPharma

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ARRY-502

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01349725

ARRAY-502-102

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.