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

Phase 1TerminatedNCT00875628

Pfizer24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

PF-00868554 or PlaceboDRUG

Dosage Form: Oral solution Dosage: PF-00868554 100 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days

PF-00868554 or PlaceboDRUG

Dosage Form: Oral solution Dosage: PF-00868554 300 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days

PF-00868554 or PlaceboDRUG

Dosage Form: Tablet Dosage: PF-00868554 600 mg or placebo under fed conditions Frequency: BID (twice daily) Duration: 14 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Glendale, California, United States

Outcomes

Primary Outcomes

Plasma PF-00868554 concentrations

Time frame: Day 1-Day 17

Urine PF-00868554 concentrations

Time frame: Day 1 and Day 14

Adverse event monitoring and Physical examination

Time frame: Day 0-Day 17

ECGs and vital signs (Blood pressure and Pulse rate)

Time frame: Day 1-Day 17

Clinical safety laboratory tests

Time frame: Day 0, Day 7, and Day 17

Data from ClinicalTrials.gov

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