Back to resultsMultiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects
Primary Purpose
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pf-05175157
placebo
midazolam
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus
Eligibility Criteria
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).
- Body Mass Index (BMI) of 25 to 35 kg/m2 inclusive; and a total body weight >50 kg (110 lbs).
- 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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm Label Pf-05175157, placebo, midazolam
Arm Description
Outcomes
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax)
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Plasma Decay Half-Life (t1/2)
Apparent Volume of Distribution (Vz/F)
Apparent Oral Clearance (CL/F)
Accumulation Ratio (Rac)
Ae,tau
Ae%
Clr
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Plasma Decay Half-Life (t1/2)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
fasting triglycerides
fasting LDL-cholesterol
fasting total cholesterol
fasting HDL cholesterol
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01757756
Brief Title
Multiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects
Official Title
A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Effect On Midazolam Pharmacokinetics Of Multiple Oral Doses Of PF-05175157 In Otherwise Healthy Overweight And Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm Label Pf-05175157, placebo, midazolam
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pf-05175157
Intervention Description
200-mg administered twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo administered twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
midazolam 3-mg admistered as single doses on Day 0 and Day 11.
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose
Title
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Title
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Title
Plasma Decay Half-Life (t1/2)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Title
Apparent Volume of Distribution (Vz/F)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Title
Apparent Oral Clearance (CL/F)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Title
Accumulation Ratio (Rac)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours postdose
Title
Ae,tau
Time Frame
0-12 hr
Title
Ae%
Time Frame
0-12 hr
Title
Clr
Time Frame
0-12 hr
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Title
Plasma Decay Half-Life (t1/2)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Title
fasting triglycerides
Time Frame
14 days
Title
fasting LDL-cholesterol
Time Frame
14 days
Title
fasting total cholesterol
Time Frame
14 days
Title
fasting HDL cholesterol
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Body Mass Index (BMI) of 25 to 35 kg/m2 inclusive; and a total body weight >50 kg (110 lbs).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1731017&StudyName=Multiple%20Dose%20Safety%20Toelrability%2C%20Pharmacokinetics%20and%20Midazolam%20Interaction%20In%20Healthy%20Overweight%20And%20Obese%20Subjects
Description
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Learn more about this trial
Multiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects
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