Single-Dose Safety Study of APD791 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability, Pharmacokinetics, and Pharmacodynamics of APD791 Administered to Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00529646

Enrollment

Registered

2007-09-14

Start date

2007-07-31

Completion date

Unknown

Last updated

2008-12-30

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 APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791 when administered as a single oral dose to healthy adult subjects.

Interventions

DRUGAPD791

Study design

Allocation

RANDOMIZED

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 * 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	—

Secondary

Measure	Time frame
Pharmacokinetic and pharmacodynamic assessments	—

Countries

United States

Outcome results

None listed

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