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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

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 .

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-06260414 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : February 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: SAD cohorts 1-7 Experimental Arm 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

Placebo Comparator: SAD Cohorts 1-7 Placebo Arm Drug: Placebo
Subjects will receive single doses of PF-06260414 matching placebo (solution) in a dose escalation format

Experimental: MAD cohorts 2-6 Experimental Arm Drug: PF-06260414
Subjects will receive PF-06260414 doses (solution) twice daily for 14 days

Placebo Comparator: MAD cohorts 2-6 Placebo Arm Drug: Placebo
Subjects will receive PF-06260414 matching placebo doses (solution) of 3, 10, 30, 100mg BID and 60 mg QD for 14 days

Experimental: Japanese MAD cohort 7 Experimental arm Drug: PF-06260414
Japanese subjects may receive the highest dose of PF-06460414 tested in non Japanese cohort twice daily for 14 days

Placebo Comparator: Japanese MAD cohort 7 Placebo Arm Drug: Placebo
Japanese subjects may receive PF-06260414 matching placebo doses (solution) twice daily for 14 days




Primary Outcome Measures :
  1. Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) [ Time Frame: 6 weeks ]
  2. Changes from baseline in 12-lead ECG parameters [ Time Frame: 6 weeks ]
    Quantitative changes in ECG intervals

  3. Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events [ Time Frame: 6 weeks ]
  4. Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology (including total Hb and hematocrit), chemistry, fasting glucose, urinalysis [ Time Frame: 6 weeks ]
  5. 24 hour creatinine clearance (baseline and day 14). [ Time Frame: Baseline, Day 14 ]
  6. Changes from baseline in total testosterone, free testosterone, estradiol, LH, FSH, SHBG. [ Time Frame: 6 weeks ]
  7. Changes from baseline in Prostate Specific Antigen (PSA). [ Time Frame: 6 weeks ]
  8. Changes from baseline in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Single Dose: Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, and t½,Cmax(dn), AUCinf(dn), AUClast(dn), t½. [ Time Frame: 6 weeks ]
  2. 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 ]
  3. Urinary Pharmacokinetics: Amount of PF 06260414 excreted unchanged (AE and AE%), renal clearance (CLr). [ Time Frame: 6 weeks ]
  4. 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

  5. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070939


Locations
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United States, Connecticut
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02070939    
Other Study ID Numbers: B7411001
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Keywords provided by Pfizer:
Phase 1
Randomized
Double Blind
Placebo-Controlled
Single and Multiple Dose Escalation
Safety Tolerability
PK
PD
PF-06460414