A Multiple-Dose Study to Assess the Safety, Tolerability, and Steady State Pharmacokinetics of APD791 in Healthy Volunteers

Arena Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: APD791

Study type: Interventional

Funder types: Industry

Identifiers

NCT00619931

APD791-002

Details and patient eligibility

About

The APD791-002 study is designed primarily to evaluate the safety, tolerability, and pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects.

Enrollment: 50 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult men and women, ages 19-45
• Non smokers

Exclusion criteria

• History of a bleeding disorder
• Use of any drug known to have an effect on coagulation or clotting or any anti-platelet therapy within 2 weeks of the screening
• Recently donated blood or had significant blood loss
• Current use of a prescription medication
• Pregnant females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 5 patient groups

1

Experimental group

Description:

APD791 or placebo

Treatment:

Drug: APD791

2

Experimental group

Description:

APD791 or placebo

Treatment:

Drug: APD791

3

Experimental group

Description:

APD791 or placebo

Treatment:

Drug: APD791

4

Experimental group

Description:

APD791 or placebo

Treatment:

Drug: APD791

5

Experimental group

Description:

APD791 or placebo

Treatment:

Drug: APD791