Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 21 - 50 |
| Updated: | 11/16/2018 |
| Start Date: | February 2014 |
| End Date: | March 2015 |
A Phase 1, Randomized, Double Blind (Sponsor Open), Placebo Controlled, Single- And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06260414 In Healthy Western And Japanese Male Subjects
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 .
Selective Androgen Receptor Modulator in humans. The goal is to assess the safety,
tolerability, pharmacokinetics and pharmacodynamics in healthy western and Japanese male
subjects .
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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