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

Phase 1

Terminated

• Conditions: Healthy Volunteers
• Interventions: Drug: PF-00868554 or Placebo

• Registration Number: NCT00875628
• Lead Sponsor: Pfizer

Brief Summary

Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.

Detailed Description

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.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-21
• Last Update Posted: 2009-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	PF-00868554 or Placebo	PF-00868554 100 mg or placebo
Cohort 2	PF-00868554 or Placebo	PF-00868554 300 mg or placebo
Cohort 3	PF-00868554 or Placebo	PF-00868554 600 mg or placebo

Primary Outcome Measures

Name	Time	Method
Plasma PF-00868554 concentrations	Day 1-Day 17
Urine PF-00868554 concentrations	Day 1 and Day 14
Adverse event monitoring and Physical examination	Day 0-Day 17
ECGs and vital signs (Blood pressure and Pulse rate)	Day 1-Day 17
Clinical safety laboratory tests	Day 0, Day 7, and Day 17

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Glendale, California, United States