- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01807377
Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects
September 16, 2013 updated by: Pfizer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Chula Vista, California, United States, 91911
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
200 mg tablet administered twice per day for 14 days
2mg administered as single doses on Days 0 and 11
|
Experimental: Placebo, Midazolam
Day 0: Midazolam 2 mg administered alone Days 1-14: Placebo administered BID Day 11: Midazolam and Placebo
|
2mg administered as single doses on Days 0 and 11
Placebo administered twice per day for 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Plasma PF-05175157 Concentration (Cmax)
Time Frame: 0 - 10 hrs postdose
|
Single Dose
|
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
|
Single Dose
|
0 - 10 hrs postdose
|
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)
Time Frame: 0 - 10 hrs postdose
|
Single Dose
|
0 - 10 hrs postdose
|
Maximum Observed Plasma PF-05175157 Concentration (Cmax)
Time Frame: 0 - 48 hours postdose
|
Steady State
|
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
|
Steady State
|
0 - 48 hours postdose
|
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)
Time Frame: 0 - 48 hours postdose
|
Steady State
|
0 - 48 hours postdose
|
Apparent Oral Clearance of PF-05175157 (CL/F)
Time Frame: 0 - 48 hours postdose
|
0 - 48 hours postdose
|
|
Accumulation Ratio of PF-05175157 (Rac)
Time Frame: 0 - 10 hours postdose
|
0 - 10 hours postdose
|
|
Plasma Decay Half-Life of PF-05175157 (t1/2)
Time Frame: 0 - 48 hours postdose
|
0 - 48 hours postdose
|
|
Apparent Volume of Distribution of PF-05175157 (Vz/F)
Time Frame: 0 - 48 hours postdose
|
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
|
0 - 24 hours postdose
|
Renal Clearance for PF-05175157 (CLr)
Time Frame: 0 - 24 hours post dose
|
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
|
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
|
0 - 48 hours postdose
|
|
Maximum Observed Plasma Concentration for midazolam (Cmax)
Time Frame: 0 - 48 hours postdose
|
0 - 48 hours postdose
|
|
Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax)
Time Frame: 0 - 48 hours post dose
|
0 - 48 hours post dose
|
|
Plasma Decay Half-Life of midazolam (t1/2)
Time Frame: 0 - 48 hours postdose
|
0 - 48 hours postdose
|
|
Fasting triglycerides
Time Frame: 14 days
|
14 days
|
|
Total cholesterol
Time Frame: 14 days
|
14 days
|
|
LDL cholesterol
Time Frame: 14 days
|
14 days
|
|
HDL cholesterol
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
March 6, 2013
First Submitted That Met QC Criteria
March 6, 2013
First Posted (Estimate)
March 8, 2013
Study Record Updates
Last Update Posted (Estimate)
September 17, 2013
Last Update Submitted That Met QC Criteria
September 16, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Body Weight
- Diabetes Mellitus, Type 2
- Overweight
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Midazolam
Other Study ID Numbers
- B1731021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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