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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014