A Safety Study of ARRY-371797 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ARRY-371797, p38 inhibitor; oral; Drug: Placebo; oral

• Registration Number: NCT00790049
• Lead Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-31
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-11
• Study First Posted: 2008-11-13
• Primary Completion: 2009-01-21
• Study Completion: 2009-01-21
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARRY-371797	ARRY-371797, p38 inhibitor; oral	-
Placebo	Placebo; oral	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

PPD Phase I Clinic; 🇺🇸 Austin, Texas, United States