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A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Glendale, California, 91206 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and female Japanese subjects between the ages of 18 and 55 years.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Male subjects with a history of subfertility/infertility and other conditions that in
the opinion of the investigator may affect fertility.

- Exposure within the previous three months to a drug known to have a negative effect on
skeletal muscle or reproductive organs.

- Pregnant or nursing females; females of childbearing potential.

NCT00875628
Pfizer
Terminated
A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers

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A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers
A Phase 1, Randomized, Double Blind (Sponsor-Open), Placebo Controlled, Dose Escalation, Multiple Dose Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers
Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.
Study A8121018 was prematurely discontinued due to FDA instructions stating that Study A8121018 could not be performed under US IND 78,910, which was provided by the meeting on August 13, 2009. And then the termination was decided by Pfizer on September 8, 2009 prior to subject dosing with PF-00868554. There were no safety concerns regarding the study in the decision to terminate the trial.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Healthy Volunteers
  • Drug: PF-00868554 or Placebo
    Dosage Form: Oral solution Dosage: PF-00868554 100 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days
  • Drug: PF-00868554 or Placebo
    Dosage Form: Oral solution Dosage: PF-00868554 300 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days
  • Drug: PF-00868554 or Placebo
    Dosage Form: Tablet Dosage: PF-00868554 600 mg or placebo under fed conditions Frequency: BID (twice daily) Duration: 14 days
  • Cohort 1
    PF-00868554 100 mg or placebo
    Intervention: Drug: PF-00868554 or Placebo
  • Cohort 2
    PF-00868554 300 mg or placebo
    Intervention: Drug: PF-00868554 or Placebo
  • Cohort 3
    PF-00868554 600 mg or placebo
    Intervention: Drug: PF-00868554 or Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
April 2009
April 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and female Japanese subjects between the ages of 18 and 55 years.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
  • Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
  • Pregnant or nursing females; females of childbearing potential.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00875628
A8121018
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

ICMJE     Data element required by the

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

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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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