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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-03-31

Brief Summary

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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 .

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAD cohorts 1-7 Experimental Arm

Group Type EXPERIMENTAL

PF-06260414

Intervention Type DRUG

Subjects will receive single doses of 1,3,6,30,100,200, 400 mg of PF-06260414 (solution) in a dose escalating format

SAD Cohorts 1-7 Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive single doses of PF-06260414 matching placebo (solution) in a dose escalation format

MAD cohorts 2-6 Experimental Arm

Group Type EXPERIMENTAL

PF-06260414

Intervention Type DRUG

Subjects will receive PF-06260414 doses (solution) twice daily for 14 days

MAD cohorts 2-6 Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive PF-06260414 matching placebo doses (solution) of 3, 10, 30, 100mg BID and 60 mg QD for 14 days

Japanese MAD cohort 7 Experimental arm

Group Type EXPERIMENTAL

PF-06260414

Intervention Type DRUG

Japanese subjects may receive the highest dose of PF-06460414 tested in non Japanese cohort twice daily for 14 days

Japanese MAD cohort 7 Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Japanese subjects may receive PF-06260414 matching placebo doses (solution) twice daily for 14 days

Interventions

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PF-06260414

Subjects will receive single doses of 1,3,6,30,100,200, 400 mg of PF-06260414 (solution) in a dose escalating format

Intervention Type DRUG

Placebo

Subjects will receive single doses of PF-06260414 matching placebo (solution) in a dose escalation format

Intervention Type DRUG

PF-06260414

Subjects will receive PF-06260414 doses (solution) twice daily for 14 days

Intervention Type DRUG

Placebo

Subjects will receive PF-06260414 matching placebo doses (solution) of 3, 10, 30, 100mg BID and 60 mg QD for 14 days

Intervention Type DRUG

PF-06260414

Japanese subjects may receive the highest dose of PF-06460414 tested in non Japanese cohort twice daily for 14 days

Intervention Type DRUG

Placebo

Japanese subjects may receive PF-06260414 matching placebo doses (solution) twice daily for 14 days

Intervention Type DRUG

Eligibility Criteria

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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).

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes