A Safety Study of ARRY-502 in Healthy Subjects | NCT01349725

Studies
A Safety Study of ARRY-502 in Healthy Subjects

NCT01349725

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Oct 5, 2020Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Healthy

Interventions

ARRY-502
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

May 5, 2011

First Submission Date that Met QC Criteria

May 6, 2011

First Posted Date

May 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2020

Last Update Posted Date

Oct 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARRY-502	Experimental		Drug: ARRY-502
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARRY-502	Drug	Oral; multiple dose, escalating	ARRY-502
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided