A Safety Study of ARRY-502 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ARRY-502; Drug: Placebo

• Registration Number: NCT01349725
• Lead Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-05-06
• Study First Posted: 2011-05-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARRY-502	ARRY-502	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.	2 weeks
Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests, electrocardiograms and vital signs.	3 weeks

Secondary Outcome Measures

Name	Time	Method
Characterize the pharmacodynamics of the study drug as determined by laboratory assays.	2 weeks