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.

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.