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Completed

NCT Number: NCT00740649

Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of HSD-016

This is a single ascending dose study of HSD-016 to provide the initial assessment of the safety, tolerability, how the drug is absorbed and eliminated, and it's effect on the body in Japanese male subjects.

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Key information

Conditions

Healthy Subjects

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Toshima-ku, Tokyo, 171-0014, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion:

  • Men, aged 20 to 45 years inclusive at screening.
  • Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg
  • Healthy as determined by the investigator on the basis of screening evaluations.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion:

  • No presence or history of any disorder that may prevent the successful completion of the study.
  • No history of drug abuse within 1 year.

Treatment and study plan

HSD-016

Drug

Placebo

Drug

Primary outcomes

  1. clinical labs, adverse events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Single Ascending Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of HSD-016 Administered Orally To Healthy Japanese Male Subjects

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 25, 2008
Registry last updated
Mar 31, 2009

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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