A Safety Study of ARRY-371797 in Healthy Subjects

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00790049

Collaborator

(none)

Enrollment

Location

Arms

2.7

Actual Duration (Months)

14.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1 study, involving both 1-day and 8-day dosing periods, designed to test the safety of investigational study drug ARRY-371797 in healthy subjects. Approximately 48 healthy subjects from the US will be enrolled in this study.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ARRY-371797, p38 inhibitor; oral Drug: Placebo; oral	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Single Day And Multiple Day Ascending Dose Study To Evaluate The Safety And Pharmacokinetics Of Orally Administered ARRY-371797 In Healthy Volunteers

Actual Study Start Date :

Oct 31, 2008

Actual Primary Completion Date :

Jan 21, 2009

Actual Study Completion Date :

Jan 21, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ARRY-371797	Drug: ARRY-371797, p38 inhibitor; oral single dose and multiple dose, escalating
Placebo Comparator: Placebo	Drug: Placebo; oral matching placebo

Arm

Intervention/Treatment

Experimental: ARRY-371797

Drug: ARRY-371797, p38 inhibitor; oral

single dose and multiple dose, escalating

Placebo Comparator: Placebo

Drug: Placebo; oral

matching placebo

Outcome Measures

Primary Outcome Measures

Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [Duration of study]
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations. [Duration of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Key Inclusion Criteria:

Healthy male or female between the ages of 18 and 60 years.
Females must be of nonchildbearing potential.
Body weight > 50 kg (110 lbs) and < 113 kg (250 lbs).
Additional criteria exist.

Key Exclusion Criteria:

A positive test for drugs or alcohol.
Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug.
Additional criteria exist.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Phase I Clinic	Austin	Texas	United States	78744

Sponsors and Collaborators

Array Biopharma, now a wholly owned subsidiary of Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Array Biopharma, now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00790049

Other Study ID Numbers:

ARRAY-797-107
C4411015

First Posted:

Nov 13, 2008

Last Update Posted:

May 5, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of May 5, 2022