A Safety Study of ARRY-502 in Healthy Subjects

September 30, 2020 updated by: Array Biopharma, now a wholly owned subsidiary of Pfizer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral; matching placebo
Experimental: ARRY-502
Drug: ARRY-502
Oral; multiple dose, escalating

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Characterize the pharmacodynamics of the study drug as determined by laboratory assays.
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 5, 2011

First Submitted That Met QC Criteria

May 6, 2011

First Posted (Estimate)

May 9, 2011

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ARRAY-502-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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