A Safety Study of ARRY-371797 in Healthy Subjects

Array BioPharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; oral; Drug: ARRY-371797, p38 inhibitor; oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT00790049

ARRAY-797-107

C4411015 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

ARRY-371797

Experimental group

Treatment:

Drug: ARRY-371797, p38 inhibitor; oral

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo; oral