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

Phase 1

Completed

• Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders
• Interventions: Drug: Pf-05175157; Drug: placebo; Drug: midazolam

• Registration Number: NCT01757756
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-23
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-21
• Last Update Submitted: 2012-12-21
• Study First Posted: 2012-12-31
• Last Update Posted: 2012-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm Label Pf-05175157, placebo, midazolam	Pf-05175157	-
Arm Label Pf-05175157, placebo, midazolam	placebo	-
Arm Label Pf-05175157, placebo, midazolam	midazolam	-

Primary Outcome Measures

Name	Time	Method
fasting triglycerides	14 days
fasting LDL-cholesterol	14 days
fasting total cholesterol	14 days
fasting HDL cholesterol	14 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Maximum Observed Plasma Concentration (Cmax)	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Plasma Decay Half-Life (t1/2)	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Apparent Volume of Distribution (Vz/F)	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Apparent Oral Clearance (CL/F)	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Accumulation Ratio (Rac)	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours postdose
Ae,tau	0-12 hr
Ae%	0-12 hr
Clr	0-12 hr
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 South Miami, Florida, United States