A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults

NCT01707082

Last updated date
Study Location
Pfizer Investigational Site
Brussels, , B-1070, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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 subjects between the ages of 18 and 55 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). Women must be of non childbearing potential.

- Body Mass Index (BMI) of 27.0 to 35.0 kg/m2 (Part A) or 17.5 to 30.5 kg/m2 (Part B); 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 clinically significant drug allergies, but excluding
untreated, asymptomatic, seasonal allergies at time of dosing).


- Subject with any contraindication to midazolam according to the country specific
labeling or subject with previous intolerance or allergy to benzodiazepines
(applicable to Part B of study only).


- Subjects who were enrolled in Part A are excluded from participation in Part B of this
study.


- Subjects who have previously participated in a study with PF-06282999.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults
Official Title  ICMJE A Phase 1, Randomized, Placebo-Controlled, Multiple Dose Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of PF-06282999 In Healthy Overweight Subjects And A Fixed-Sequence Study To Assess The Effect Of PF-06282999 On The Pharmacokinetics Of Midazolam In Healthy Subjects
Brief Summary Part A of the study will test the safety, the amount of drug in the body, and effects of the drug in the body after multiple doses. This will be conducted in healthy overweight adults. Part B of the study will test the effects of multiple doses of the investigational drug on the amount of midazolam, an approved drug, in healthy adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06282999
    Tablet, 10 mg, every 8 hours, 14 days
  • Drug: Placebo
    Tablet, 0 mg, every 8 hours, 14 days
  • Drug: PF-06282999
    Tablet, 30 mg, every 8 hours, 14 days
  • Drug: PF-06282999
    Tablet, 100 mg, every 8 hours, 14 days
  • Drug: PF-06282999
    Tablet, 250 mg, every 8 hours, 14 days
  • Drug: PF-06282999
    Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days
  • Drug: Placebo
    Tablet, 0 mg, every 8 or 12 hours, 14 days
  • Drug: midazolam
    Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
  • Drug: PF-06282999
    Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
Study Arms  ICMJE
  • Experimental: Part A Cohort 1
    Interventions:
    • Drug: PF-06282999
    • Drug: Placebo
  • Experimental: Part A Cohort 2
    Interventions:
    • Drug: PF-06282999
    • Drug: Placebo
  • Experimental: Part A Cohort 3
    Interventions:
    • Drug: PF-06282999
    • Drug: Placebo
  • Experimental: Part A Cohort 4
    Interventions:
    • Drug: PF-06282999
    • Drug: Placebo
  • Experimental: Part A Cohort 5
    Interventions:
    • Drug: PF-06282999
    • Drug: Placebo
  • Experimental: Part B Cohort 1
    Interventions:
    • Drug: midazolam
    • Drug: PF-06282999
  • Experimental: Part B Cohort 2
    Interventions:
    • Drug: midazolam
    • Drug: PF-06282999
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2013)
69
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2012)
68
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 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). Women must be of non childbearing potential.
  • Body Mass Index (BMI) of 27.0 to 35.0 kg/m2 (Part A) or 17.5 to 30.5 kg/m2 (Part B); 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 clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Subject with any contraindication to midazolam according to the country specific labeling or subject with previous intolerance or allergy to benzodiazepines (applicable to Part B of study only).
  • Subjects who were enrolled in Part A are excluded from participation in Part B of this study.
  • Subjects who have previously participated in a study with PF-06282999.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01707082
Other Study ID Numbers  ICMJE B5211002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP