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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: APD791

• Registration Number: NCT00619931
• Lead Sponsor: Arena Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-11
• Study First Posted: 2008-02-21
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	APD791	APD791 or placebo
5	APD791	APD791 or placebo
1	APD791	APD791 or placebo
2	APD791	APD791 or placebo
3	APD791	APD791 or placebo

Primary Outcome Measures

Name	Time	Method
Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters	Throughout study duration

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic assessments (e.g., platelet function)	Throughout study duration
Pharmacokinetic assessments	Throughout study duration

Trial Locations

Locations (1)

MDS Pharma Services; 🇺🇸 Lincoln, Nebraska, United States