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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00790049

Enrollment

Registered

2008-11-13

Start date

2008-10-31

Completion date

2009-01-21

Last updated

2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGARRY-371797, p38 inhibitor; oral

single dose and multiple dose, escalating

DRUGPlacebo; oral

matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026