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A Multiple Dose Study Of PF-05161704 In Healthy Volunteers

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
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.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female (non-childbearing potential) subjects between the ages of
18 and 55 years, inclusive

- Body Mass Index (BMI) of 24.5 to 35.5 kg/m2 and a total body weight >50 kg (110 lbs.)

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

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Any condition possibly affecting drug absorption (e.g., gastrectomy).

- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of
beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.

- History or evidence of habitual use of tobacco or nicotine containing products within
3 months of screening or positive cotinine test at screening or Day -1.

NCT01202266
Pfizer
Terminated
A Multiple Dose Study Of PF-05161704 In Healthy Volunteers

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A Multiple Dose Study Of PF-05161704 In Healthy Volunteers
A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of Pf-05161704 After Administration Of Multiple Escalating Oral Doses In Healthy Volunteers
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Diabetes Mellitus, Type 2
  • Drug: PF-05161704 or Placebo
    PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
  • Drug: PF-05161704 or Placebo
    PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner or once daily for 14 days immediately after breakfast
  • Drug: PF-05161704 or Placebo
    PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast
  • Experimental: 5 mg PF-05161704 or Placebo
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: 15 mg PF-05161704 or Placebo
    Planned dose: may be modified based on emerging PK and safety data.
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: 50 mg PF-05161704 or Placebo
    Planned dose: may be modified based on emerging PK and safety data.
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: 150 mg PF-05161704 or Placebo
    Planned dose: may be modified based on emerging PK and safety data.
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: xx mg PF-05161704 or Placebo
    Planned dose and dosing regimen will be determined based on emerging PK and safety data.
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: xxx mg PF-05161704 or Placebo
    Dose will be determined based on data from previous 5 arms.
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: yy mg PF-05161704 or Placebo
    Dose will be determined based on data from previous 6 arms
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: yyy mg PF-05161704 or Placebo
    Dose will be determined based on data from previous 7 arms.
    Intervention: Drug: PF-05161704 or Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive
  • Body Mass Index (BMI) of 24.5 to 35.5 kg/m2 and a total body weight >50 kg (110 lbs.)

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (e.g., gastrectomy).
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  • History or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening or positive cotinine test at screening or Day -1.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01202266
B2911002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2011

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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