Clinical trial NCT02070939: Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Randomized
Double Blind
Placebo-Controlled
Single and Multiple Dose Escalation
Safety Tolerability
PK
PD
PF-06460414
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-02-25
Enrollment: 72
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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 .


Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate)
timeFrame: 6 weeks
measure: Changes from baseline in 12-lead ECG parameters
timeFrame: 6 weeks
measure: Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events
timeFrame: 6 weeks
measure: Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology (including total Hb and hematocrit), chemistry, fasting glucose, urinalysis
timeFrame: 6 weeks
measure: 24 hour creatinine clearance (baseline and day 14).
timeFrame: Baseline, Day 14
measure: Changes from baseline in total testosterone, free testosterone, estradiol, LH, FSH, SHBG.
timeFrame: 6 weeks
measure: Changes from baseline in Prostate Specific Antigen (PSA).
timeFrame: 6 weeks
measure: Changes from baseline in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides.
timeFrame: 6 weeks
Secondary outcomes:
measure: Single Dose: Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, and t½,Cmax(dn), AUCinf(dn), AUClast(dn), t½.
timeFrame: 6 weeks
measure: Multiple Dose: Cmax, Tmax Ctrough, C,av,AUC,CL/F, Vz/F, Rac , Rac,Cmax , PTR, Cmax(dn),AUCτ(dn), t½.
timeFrame: 6 weeks
measure: Urinary Pharmacokinetics: Amount of PF 06260414 excreted unchanged (AE and AE%), renal clearance (CLr).
timeFrame: 6 weeks
measure: Single Dose: AUC(hormone or PSA), C0(hormone or PSA), Maximum PCB, Cmax(hormone or PSA), Cmin(hormone or PSA), Tmax(hormone or PSA), Tmin(hormone or PSA).
timeFrame: 6 weeks
measure: Multiple Dose: AUC(hormone or PSA), C0(hormone or PSA), Cmax(hormone or PSA), Cmin(hormone or PSA), Tmax(hormone or PSA), Tmin(hormone or PSA).
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Bhattacharya I, Tarabar S, Liang Y, Pradhan V, Owens J, Oemar B. Safety, Pharmacokinetic, and Pharmacodynamic Evaluation After Single and Multiple Ascending Doses of a Novel Selective Androgen Receptor Modulator in Healthy Subjects. Clin Ther. 2016 Jun;38(6):1401-1416. doi: 10.1016/j.clinthera.2016.03.025. Epub 2016 Apr 13.