A Safety Study of ARRY-502 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01349725

Enrollment

Registered

2011-05-09

Start date

2011-05-31

Completion date

2011-09-30

Last updated

2020-10-05

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

Conditions

Healthy

Keywords

Safety

Brief summary

This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects from the United States will be enrolled in this study.

Interventions

DRUGARRY-502

Oral; 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 50 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Healthy male or female between the ages of 18 and 50 years. * Females must be of nonchildbearing potential. * Body mass index (BMI) of 18 to 32 and a total body weight \> 50 kg (110 lbs) and \< 114 kg (250 lbs). * Additional criteria exist. Key

Exclusion criteria

* Evidence or history of clinically significant disease (excepting allergic rhinitis). * Evidence of hepatitis B, hepatitis C or human immunodeficiency virus (HIV). * Gastrointestinal surgery that may interfere with motility or absorption. * Serious illness requiring hospitalization within the previous 6 months. * A positive test for drugs or alcohol. * Recent use of tobacco- or nicotine-containing products. Use of any medications, grapefruit or supplements within the previous 14 days. * Use of corticosteroids within the previous 28 days. * Recent history of blood, plasma or platelet donation. * Treatment with a small-molecule investigational drug within the previous 30 days or any biologic therapy within the previous 6 months. * Prior exposure to investigational study drug ARRY-502. * Additional criteria exist.

Design outcomes

Primary

Measure	Time frame
Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests, electrocardiograms and vital signs.	3 weeks
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.	2 weeks

Secondary

Measure	Time frame
Characterize the pharmacodynamics of the study drug as determined by laboratory assays.	2 weeks

Countries

United States

Outcome results

None listed

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