Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

This single and multiple ascending dose study is the first evaluation of PF-0626414, a Selective Androgen Receptor Modulator in humans. The goal is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy western and Japanese male subjects .

Key facts

Study ID

NCT02070939

Run by

Pfizer

People needed

72

Starts

2014-02-01

Expected to finish

2015-03-01

Last updated by the study team

2018-11-14

Who can join

Age: 21 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy male between the ages of 21 and 50 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• Additional inclusion criteria for subjects to be enrolled in Japanese cohort only: Japanese subjects who have four Japanese grandparents born in Japan.

You may not qualify if…

• Serum total testosterone level <270 or >1070 ng/dL
• Serum Prostate Specific Antigen (PSA) level >4 ng/mL.
• Hematocrit >48%.
• eGFR >150 ml/min/1.73m2.

Where it is running

• New Haven Clinical Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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