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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00619931

Enrollment

Registered

2008-02-21

Start date

2008-01-31

Completion date

2008-06-30

Last updated

2022-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy adult volunteers

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.

Interventions

DRUGAPD791

APD791 or matching placebo in escalating doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Pharmacokinetic assessments	Throughout study duration
Pharmacodynamic assessments (e.g., platelet function)	Throughout study duration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026