NCT02070939

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

1.1 years

First QC Date

February 22, 2014

Last Update Submit

November 12, 2018

Conditions

Healthy

Keywords

Phase 1RandomizedDouble BlindPlacebo-ControlledSingle and Multiple Dose EscalationSafety TolerabilityPKPDPF-06460414

Outcome Measures

Primary Outcomes (8)

  • Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate)

    6 weeks

  • Changes from baseline in 12-lead ECG parameters

    Quantitative changes in ECG intervals

    6 weeks

  • Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events

    6 weeks

  • Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology (including total Hb and hematocrit), chemistry, fasting glucose, urinalysis

    6 weeks

  • 24 hour creatinine clearance (baseline and day 14).

    Baseline, Day 14

  • Changes from baseline in total testosterone, free testosterone, estradiol, LH, FSH, SHBG.

    6 weeks

  • Changes from baseline in Prostate Specific Antigen (PSA).

    6 weeks

  • Changes from baseline in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides.

    6 weeks

Secondary Outcomes (5)

  • Single Dose: Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, and t½,Cmax(dn), AUCinf(dn), AUClast(dn), t½.

    6 weeks

  • Multiple Dose: Cmax, Tmax Ctrough, C,av,AUC,CL/F, Vz/F, Rac , Rac,Cmax , PTR, Cmax(dn),AUCτ(dn), t½.

    6 weeks

  • Urinary Pharmacokinetics: Amount of PF 06260414 excreted unchanged (AE and AE%), renal clearance (CLr).

    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).

    6 weeks

  • 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).

    6 weeks

Study Arms (6)

SAD cohorts 1-7 Experimental Arm

EXPERIMENTAL
Drug: PF-06260414

SAD Cohorts 1-7 Placebo Arm

PLACEBO COMPARATOR
Drug: Placebo

MAD cohorts 2-6 Experimental Arm

EXPERIMENTAL
Drug: PF-06260414

MAD cohorts 2-6 Placebo Arm

PLACEBO COMPARATOR
Drug: Placebo

Japanese MAD cohort 7 Experimental arm

EXPERIMENTAL
Drug: PF-06260414

Japanese MAD cohort 7 Placebo Arm

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-06260414DRUG

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

SAD cohorts 1-7 Experimental Arm
PlaceboDRUG

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

SAD Cohorts 1-7 Placebo Arm

Eligibility Criteria

Age21 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • 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.

    PMID: 27085586DERIVED

MeSH Terms

Interventions

PF-06260414

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2014

First Posted

February 25, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

US(1)