A Safety Study of ARRY-502 in Healthy Subjects

NCT01349725 | Completed Phase 1

• 1 other identifier: ARRAY-502-102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Safety

Outcome Measures

Primary Outcomes (2)

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

  3 weeks

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

  2 weeks

Secondary Outcomes (1)

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

  2 weeks

Study Arms (2)

ARRY-502

EXPERIMENTAL

Drug: ARRY-502

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ARRY-502 DRUG

Oral; multiple dose, escalating

ARRY-502

Placebo DRUG

Oral; matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Array Biopharma, now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

Madison, Wisconsin, United States

Location

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 9, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

US (1)