A Safety Study of ARRY-502 in Healthy Subjects

NCT ID: NCT01349725

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ARRY-502

Group Type EXPERIMENTAL

ARRY-502

Intervention Type DRUG

Oral; multiple dose, escalating

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral; matching placebo

Interventions

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ARRY-502

Oral; multiple dose, escalating

Intervention Type DRUG

Placebo

Oral; matching placebo

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Array Biopharma, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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ARRAY-502-102

Identifier Type: -

Identifier Source: org_study_id

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