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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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Serum total testosterone level 1070 ng/dL

- Serum Prostate Specific Antigen (PSA) level >4 ng/mL.

- Hematocrit >48%.

- eGFR >150 ml/min/1.73m2.

NCT02070939
Pfizer
Completed
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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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, 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
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 .
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
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.
 
Completed
72
March 2015
March 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
21 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02070939
B7411001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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