A Safety Study of ARRY-371797 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00790049
First received: November 10, 2008
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: ARRY-371797, p38 inhibitor; oral
Drug: Placebo; oral
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-371797 Drug: ARRY-371797, p38 inhibitor; oral
single dose and multiple dose, escalating
Placebo Comparator: Placebo Drug: Placebo; oral
matching placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790049

Locations
United States, Texas
PPD Phase I Clinic
Austin, Texas, United States, 78744
Sponsors and Collaborators
Array BioPharma
  More Information

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00790049     History of Changes
Other Study ID Numbers: ARRAY-797-107
Study First Received: November 10, 2008
Last Updated: April 23, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014