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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. Identifier: NCT00790049
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : September 21, 2020
Information provided by (Responsible Party):
Array BioPharma ( Array Biopharma, now a wholly owned subsidiary of Pfizer )

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

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

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier (NCT number): NCT00790049

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United States, Texas
PPD Phase I Clinic
Austin, Texas, United States, 78744
Sponsors and Collaborators
Array Biopharma, now a wholly owned subsidiary of Pfizer
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Study Director: Pfizer Call Center Pfizer
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Responsible Party: Array Biopharma, now a wholly owned subsidiary of Pfizer Identifier: NCT00790049    
Other Study ID Numbers: ARRAY-797-107
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020