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

Last updated on May 11, 2018

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Study Location
Toshima-ku, Tokyo, 171-0014 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00740649
Pfizer
Completed
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of HSD-016

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Similar Trials

Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of HSD-016
Single Ascending Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of HSD-016 Administered Orally To Healthy Japanese Male Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy Subjects
  • Drug: HSD-016
  • Drug: placebo
  • Experimental: 1
    HSD-016
    Intervention: Drug: HSD-016
  • 2
    placebo
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
March 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion:

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

Exclusion:

  1. No presence or history of any disorder that may prevent the successful completion of the study.
  2. No history of drug abuse within 1 year.
Sexes Eligible for Study: Male
20 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00740649
3248A1-1001
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
March 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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