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OpenTrials
Completed

NCT Number: NCT00529646

Single-Dose Safety Study of APD791 in Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MDS Pharma Services

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APD791

Drug

Primary outcomes

  1. Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters

Secondary outcomes

  1. Pharmacokinetic and pharmacodynamic assessments

Sponsors and collaborators

Lead sponsor

Arena Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2007
First posted
Sep 14, 2007
Registry last updated
Dec 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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