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OpenTrials
Completed

NCT Number: NCT00619931

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

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.

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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
  • 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

Treatment and study plan

APD791

Drug

APD791 or matching placebo in escalating doses

Primary outcomes

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

    Time frame: Throughout study duration

Secondary outcomes

  1. Pharmacokinetic assessments

    Time frame: Throughout study duration

  2. Pharmacodynamic assessments (e.g., platelet function)

    Time frame: Throughout study duration

Sponsors and collaborators

Lead sponsor

Arena Pharmaceuticals

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 21, 2008
Registry last updated
Jul 5, 2022

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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