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

Pfizer

Status and phase

Terminated

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: PF-00868554 or Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00875628

A8121018

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.