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CompletedNCT02070939Updated Nov 14, 2018

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

A Phase 1 interventional study of PF-06260414 and Placebo in Healthy, sponsored by Pfizer. Completed at 1 site in United States. Open to male participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-14.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
Male
01

Study 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 .

02

Conditions studied

  • Healthy

Keywords

  • Phase 1
  • Randomized
  • Double Blind
  • Placebo-Controlled
  • Single and Multiple Dose Escalation
  • Safety Tolerability
  • PK
  • PD
  • PF-06460414
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    SAD cohorts 1-7 Experimental Arm

    Drug: PF-06260414

  • Placebo comparator
    SAD Cohorts 1-7 Placebo Arm

    Drug: Placebo

  • Experimental
    MAD cohorts 2-6 Experimental Arm

    Drug: PF-06260414

  • Placebo comparator
    MAD cohorts 2-6 Placebo Arm

    Drug: Placebo

  • Experimental
    Japanese MAD cohort 7 Experimental arm

    Drug: PF-06260414

  • Placebo comparator
    Japanese MAD cohort 7 Placebo Arm

    Drug: Placebo

Interventions

  • DrugPF-06260414

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

  • DrugPlacebo

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

  • DrugPF-06260414

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

  • DrugPlacebo

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

  • DrugPF-06260414

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  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

    Quantitative changes in ECG intervals

    Time frame: 6 weeks

  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 outcomes

  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).

    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

    Time frame: 6 weeks

  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

07

Study locations

1 site
  • New Haven Clinical Research Unit
    New Haven, Connecticut 06511, United States
08

References and documents

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. PubMed 27085586 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02070939
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 25, 2014
Start date
Feb 2014
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Nov 14, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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