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

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ClinicalTrials.gov Identifier: NCT01807377

Recruitment Status : Completed

First Posted : March 8, 2013

Last Update Posted : September 17, 2013

Sponsor:

Information provided by (Responsible Party):

Pfizer

Tracking Information

First Submitted Date ^ICMJE

March 6, 2013

First Posted Date ^ICMJE

March 8, 2013

Last Update Posted Date

September 17, 2013

Study Start Date ^ICMJE

April 2013

Actual Primary Completion Date

August 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum Observed Plasma PF-05175157 Concentration (Cmax) [ Time Frame: 0 - 10 hrs postdose ]
Single Dose
Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau) [ Time Frame: 0 - 10 hrs postdose ]
Single Dose
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) [ Time Frame: 0 - 10 hrs postdose ]
Single Dose
Maximum Observed Plasma PF-05175157 Concentration (Cmax) [ Time Frame: 0 - 48 hours postdose ]
Steady State
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157 [ Time Frame: 0 - 48 hours postdose ]
Steady State
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) [ Time Frame: 0 - 48 hours postdose ]
Steady State
Apparent Oral Clearance of PF-05175157 (CL/F) [ Time Frame: 0 - 48 hours postdose ]
Accumulation Ratio of PF-05175157 (Rac) [ Time Frame: 0 - 10 hours postdose ]
Plasma Decay Half-Life of PF-05175157 (t1/2) [ Time Frame: 0 - 48 hours postdose ]
Apparent Volume of Distribution of PF-05175157 (Vz/F) [ Time Frame: 0 - 48 hours postdose ]
Urinary Recovery for PF-05175157 (AE24) [ Time Frame: 0 - 24 hours postdose ]
Amount of PF-05175157 recovered in urine over 24 hours
Renal Clearance for PF-05175157 (CLr) [ Time Frame: 0 - 24 hours post dose ]
Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)] [ Time Frame: 0 - 48 hours postdose ]
Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)] [ Time Frame: 0 - 48 hours postdose ]
Maximum Observed Plasma Concentration for midazolam (Cmax) [ Time Frame: 0 - 48 hours postdose ]
Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax) [ Time Frame: 0 - 48 hours post dose ]
Plasma Decay Half-Life of midazolam (t1/2) [ Time Frame: 0 - 48 hours postdose ]
Fasting triglycerides [ Time Frame: 14 days ]
Total cholesterol [ Time Frame: 14 days ]
LDL cholesterol [ Time Frame: 14 days ]
HDL cholesterol [ Time Frame: 14 days ]

Original Primary Outcome Measures ^ICMJE

Maximum Observed Plasma PF-05175157 Concentration (Cmax) [ Time Frame: 0 - 10 hrs postdose ]
Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau) [ Time Frame: 0 - 10 hrs postdose ]
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) [ Time Frame: 0 - 10 hrs postdose ]
Maximum Observed Plasma PF-05175157 Concentration (Cmax) [ Time Frame: 0 - 48 hours postdose ]
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157 [ Time Frame: 0 - 48 hours postdose ]
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) [ Time Frame: 0 - 48 hours postdose ]
Apparent Oral Clearance of PF-05175157 (CL/F) [ Time Frame: 0 - 48 hours postdose ]
Accumulation Ratio of PF-05175157 (Rac) [ Time Frame: 0 - 10 hours postdose ]
Plasma Decay Half-Life of PF-05175157 (t1/2) [ Time Frame: 0 - 48 hours postdose ]
Apparent Volume of Distribution of PF-05175157 (Vz/F) [ Time Frame: 0 - 48 hours postdose ]
Urinary Recovery for PF-05175157 (AE24) [ Time Frame: 0 - 24 hours postdose ]
Renal Clearance for PF-05175157 (CLr) [ Time Frame: 0 - 24 hours post dose ]
Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)] [ Time Frame: 0 - 48 hours postdose ]
Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)] [ Time Frame: 0 - 48 hours postdose ]
Maximum Observed Plasma Concentration for midazolam (Cmax) [ Time Frame: 0 - 48 hours postdose ]
Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax) [ Time Frame: 0 - 48 hours post dose ]
Plasma Decay Half-Life of midazolam (t1/2) [ Time Frame: 0 - 48 hours postdose ]
Fasting triglycerides [ Time Frame: 14 days ]
Total cholesterol [ Time Frame: 14 days ]
LDL cholesterol [ Time Frame: 14 days ]
HDL cholesterol [ Time Frame: 14 days ]

Change History

Complete list of historical versions of study NCT01807377 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Diabetes Mellitus Type 2

Intervention ^ICMJE

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

Study Arms

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

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

Original Estimated Enrollment ^ICMJE

Same as current

Actual Study Completion Date

August 2013

Actual Primary Completion Date

August 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 55 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01807377

Other Study ID Numbers ^ICMJE

B1731021

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

PRS Account

Pfizer

Verification Date

September 2013

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

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