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NCT Number: NCT02070939

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

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 .

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Key information

Conditions

Healthy

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-06260414

Drug

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

Placebo

Drug

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

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

    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 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).

    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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 25, 2014
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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