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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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
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.

NCT01707082
Pfizer
Completed
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

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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
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
May 2013
May 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01707082
B5211002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2013

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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