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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00875628
• Other study ID #: A8121018
• Status: Terminated
• Phase: Phase 1
• First received: April 1, 2009
• Last updated: October 21, 2009
• Start date: April 2009
• Est. completion date: April 2009

Study information

• Verified date: October 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma PF-00868554 concentrations		Day 1-Day 17	Yes
Primary	Urine PF-00868554 concentrations		Day 1 and Day 14	Yes
Primary	Adverse event monitoring and Physical examination		Day 0-Day 17	No
Primary	ECGs and vital signs (Blood pressure and Pulse rate)		Day 1-Day 17	Yes
Primary	Clinical safety laboratory tests		Day 0, Day 7, and Day 17	Yes

External Links

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