A Safety Study of ARRY-371797 in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; oral; Drug: ARRY-371797, p38 inhibitor; oral

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Phase I Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2008
• Primary Completion (Actual): January 21, 2009
• Study Completion (Actual): January 21, 2009

Study Registration Dates

• First Submitted: November 10, 2008
• First Submitted That Met QC Criteria: November 11, 2008
• First Posted (Estimate): November 13, 2008

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ARRAY-797-107; C4411015 (Other Identifier: Pfizer)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.