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Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01807377
First received: March 6, 2013
Last updated: September 16, 2013
Last verified: September 2013
History of Changes

March 6, 2013
September 16, 2013
April 2013
August 2013   (final data collection date for primary outcome measure)
  • Maximum Observed Plasma PF-05175157 Concentration (Cmax) [ Time Frame: 0 - 10 hrs postdose ] [ Designated as safety issue: No ]
    Single Dose
  • Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau) [ Time Frame: 0 - 10 hrs postdose ] [ Designated as safety issue: No ]
    Single Dose
  • Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) [ Time Frame: 0 - 10 hrs postdose ] [ Designated as safety issue: No ]
    Single Dose
  • Maximum Observed Plasma PF-05175157 Concentration (Cmax) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
    Steady State
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157 [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
    Steady State
  • Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
    Steady State
  • Apparent Oral Clearance of PF-05175157 (CL/F) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Accumulation Ratio of PF-05175157 (Rac) [ Time Frame: 0 - 10 hours postdose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life of PF-05175157 (t1/2) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Apparent Volume of Distribution of PF-05175157 (Vz/F) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Urinary Recovery for PF-05175157 (AE24) [ Time Frame: 0 - 24 hours postdose ] [ Designated as safety issue: No ]
    Amount of PF-05175157 recovered in urine over 24 hours
  • Renal Clearance for PF-05175157 (CLr) [ Time Frame: 0 - 24 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)] [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)] [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration for midazolam (Cmax) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax) [ Time Frame: 0 - 48 hours post dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life of midazolam (t1/2) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Fasting triglycerides [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • LDL cholesterol [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • HDL cholesterol [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma PF-05175157 Concentration (Cmax) [ Time Frame: 0 - 10 hrs postdose ] [ Designated as safety issue: No ]
  • Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau) [ Time Frame: 0 - 10 hrs postdose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) [ Time Frame: 0 - 10 hrs postdose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma PF-05175157 Concentration (Cmax) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157 [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Apparent Oral Clearance of PF-05175157 (CL/F) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Accumulation Ratio of PF-05175157 (Rac) [ Time Frame: 0 - 10 hours postdose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life of PF-05175157 (t1/2) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Apparent Volume of Distribution of PF-05175157 (Vz/F) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Urinary Recovery for PF-05175157 (AE24) [ Time Frame: 0 - 24 hours postdose ] [ Designated as safety issue: No ]
  • Renal Clearance for PF-05175157 (CLr) [ Time Frame: 0 - 24 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)] [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)] [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration for midazolam (Cmax) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax) [ Time Frame: 0 - 48 hours post dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life of midazolam (t1/2) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
  • Fasting triglycerides [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • LDL cholesterol [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • HDL cholesterol [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01807377 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects
A Phase 1 Placebo-Controlled Study To Assess Safety, Tolerability, Pharmacokinetics And Effect On Midazolam Pharmacokinetics Of Multiple Oral Doses Of PF-05175157 Administered In A Tablet Formulation In Otherwise Healthy Overweight And Obese Subjects

This study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of PF-05175157 administered twice daily for 14 days in healthy overweight and obese subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Diabetes Mellitus Type 2
  • Drug: PF-05175157
    200 mg tablet administered twice per day for 14 days
  • Drug: Midazolam
    2mg administered as single doses on Days 0 and 11
  • Other: Placebo
    Placebo administered twice per day for 14 days
  • Experimental: PF-05175157, Midazolam
    Day 0: Midazolam 2 mg administered alone Days 1-14: 200 mg PF-05175157 administered BID Day 11: Midazolam and PF-05175157
    Interventions:
    • Drug: PF-05175157
    • Drug: Midazolam
  • Experimental: Placebo, Midazolam
    Day 0: Midazolam 2 mg administered alone Days 1-14: Placebo administered BID Day 11: Midazolam and Placebo
    Interventions:
    • Other: Placebo
    • Drug: Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

  • 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 25 to 35 kg/m2 inclusive; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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).
  • Evidence or history of any chronic ongoing or current pulmonary disease.
  • History of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products. Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01807377
B1731021
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2013

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