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Trial record 1 of 1 for:    NCT02070939
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Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male Subjects

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ClinicalTrials.gov Identifier: NCT02070939
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 22, 2014
First Posted Date  ICMJE February 25, 2014
Last Update Posted Date November 14, 2018
Study Start Date  ICMJE February 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2014)
  • Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) [ Time Frame: 6 weeks ]
  • Changes from baseline in 12-lead ECG parameters [ Time Frame: 6 weeks ]
    Quantitative changes in ECG intervals
  • Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events [ Time Frame: 6 weeks ]
  • Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology (including total Hb and hematocrit), chemistry, fasting glucose, urinalysis [ Time Frame: 6 weeks ]
  • 24 hour creatinine clearance (baseline and day 14). [ Time Frame: Baseline, Day 14 ]
  • Changes from baseline in total testosterone, free testosterone, estradiol, LH, FSH, SHBG. [ Time Frame: 6 weeks ]
  • Changes from baseline in Prostate Specific Antigen (PSA). [ Time Frame: 6 weeks ]
  • Changes from baseline in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2014)
  • Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) [ Time Frame: 6 weeks ]
  • Changes from baseline in 12-lead ECG parameters [ Time Frame: 6 weeks ]
    Quantitative changes in ECG intervals
  • Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events [ Time Frame: 6 weeks ]
  • Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology (including total Hb and hematocrit), chemistry, fasting glucose, urinalysis [ Time Frame: 6 weeks ]
  • 24 hour creatinine clearance (baseline and 24 hours post dose). [ Time Frame: Baseline, Day 1, Day 15 ]
  • Changes from baseline in total testosterone, free testosterone, estradiol, LH, FSH, SHBG. [ Time Frame: 6 weeks ]
  • Changes from baseline in Prostate Specific Antigen (PSA). [ Time Frame: 6 weeks ]
  • Changes from baseline in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2014)
  • Single Dose: Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, and t½,Cmax(dn), AUCinf(dn), AUClast(dn), t½. [ Time Frame: 6 weeks ]
  • Multiple Dose: Cmax, Tmax Ctrough, C,av,AUC,CL/F, Vz/F, Rac , Rac,Cmax , PTR, Cmax(dn),AUCτ(dn), t½. [ Time Frame: 6 weeks ]
  • Urinary Pharmacokinetics: Amount of PF 06260414 excreted unchanged (AE and AE%), renal clearance (CLr). [ Time Frame: 6 weeks ]
  • 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). [ Time Frame: 6 weeks ]
    The effects of PF- 06260414 on sex hormones (total testosterone, free testosterone, estradiol, SHBG, LH and FSH) will be evaluated according to the scheduled timepoints in single ascending dose study
  • 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). [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male Subjects
Official Title  ICMJE 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
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 .
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: 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
  • Drug: Placebo
    Subjects will receive single doses of PF-06260414 matching placebo (solution) in a dose escalation format
  • Drug: PF-06260414
    Subjects will receive PF-06260414 doses (solution) twice daily for 14 days
  • Drug: Placebo
    Subjects will receive PF-06260414 matching placebo doses (solution) of 3, 10, 30, 100mg BID and 60 mg QD for 14 days
  • Drug: PF-06260414
    Japanese subjects may receive the highest dose of PF-06460414 tested in non Japanese cohort twice daily for 14 days
  • Drug: Placebo
    Japanese subjects may receive PF-06260414 matching placebo doses (solution) twice daily for 14 days
Study Arms  ICMJE
  • Experimental: SAD cohorts 1-7 Experimental Arm
    Intervention: Drug: PF-06260414
  • Placebo Comparator: SAD Cohorts 1-7 Placebo Arm
    Intervention: Drug: Placebo
  • Experimental: MAD cohorts 2-6 Experimental Arm
    Intervention: Drug: PF-06260414
  • Placebo Comparator: MAD cohorts 2-6 Placebo Arm
    Intervention: Drug: Placebo
  • Experimental: Japanese MAD cohort 7 Experimental arm
    Intervention: Drug: PF-06260414
  • Placebo Comparator: Japanese MAD cohort 7 Placebo Arm
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2015)
72
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2014)
56
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02070939
Other Study ID Numbers  ICMJE B7411001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP