Clinical trial NCT01757756: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-12-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
measure: Apparent Oral Clearance (CL/F)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
measure: Accumulation Ratio (Rac)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours postdose
measure: Ae,tau
timeFrame: 0-12 hr
measure: Ae%
timeFrame: 0-12 hr
measure: Clr
timeFrame: 0-12 hr
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
measure: fasting triglycerides
timeFrame: 14 days
measure: fasting LDL-cholesterol
timeFrame: 14 days
measure: fasting total cholesterol
timeFrame: 14 days
measure: fasting HDL cholesterol
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: