A Safety Study of ARRY-371797 in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: ARRY-371797, p38 inhibitor; oralDrug: Placebo; oral
- Registration Number
- NCT00790049
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARRY-371797 ARRY-371797, p38 inhibitor; oral - Placebo Placebo; oral -
- Primary Outcome Measures
Name Time Method Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. Duration of study Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations. Duration of study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PPD Phase I Clinic
🇺🇸Austin, Texas, United States