A Safety Study of ARRY-371797 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-01-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ARRY-371797

Group Type EXPERIMENTAL

ARRY-371797, p38 inhibitor; oral

Intervention Type DRUG

single dose and multiple dose, escalating

Placebo

Group Type PLACEBO_COMPARATOR

Placebo; oral

Intervention Type DRUG

matching placebo

Interventions

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ARRY-371797, p38 inhibitor; oral

single dose and multiple dose, escalating

Intervention Type DRUG

Placebo; oral

matching placebo

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes