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A Safety Study of ARRY-371797 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00790049
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : April 24, 2012
Sponsor:
Information provided by (Responsible Party):
Array BioPharma

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study Start Date : October 2008
Primary Completion Date : January 2009
Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: ARRY-371797 Drug: ARRY-371797, p38 inhibitor; oral
single dose and multiple dose, escalating
Placebo Comparator: Placebo Drug: Placebo; oral
matching placebo



Primary Outcome Measures :
  1. 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 ]
  2. Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations. [ Time Frame: Duration of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790049


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

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00790049     History of Changes
Other Study ID Numbers: ARRAY-797-107
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012