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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-06260414; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02070939

B7411001

Details and patient eligibility

About

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 .

Enrollment: 72 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 6 patient groups, including a placebo group

SAD cohorts 1-7 Experimental Arm

Experimental group

Treatment:

Drug: PF-06260414

Drug: PF-06260414

Drug: PF-06260414

SAD Cohorts 1-7 Placebo Arm

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

MAD cohorts 2-6 Experimental Arm

Experimental group

Treatment:

Drug: PF-06260414

Drug: PF-06260414

Drug: PF-06260414

MAD cohorts 2-6 Placebo Arm

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Japanese MAD cohort 7 Experimental arm

Experimental group

Treatment:

Drug: PF-06260414

Drug: PF-06260414

Drug: PF-06260414

Japanese MAD cohort 7 Placebo Arm

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo