Clinical trial NCT01807377: Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-03-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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:

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.

Primary outcomes:
measure: Maximum Observed Plasma PF-05175157 Concentration (Cmax)
timeFrame: 0 - 10 hrs postdose
measure: Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau)
timeFrame: 0 - 10 hrs postdose
measure: Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)
timeFrame: 0 - 10 hrs postdose
measure: Maximum Observed Plasma PF-05175157 Concentration (Cmax)
timeFrame: 0 - 48 hours postdose
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157
timeFrame: 0 - 48 hours postdose
measure: Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)
timeFrame: 0 - 48 hours postdose
measure: Apparent Oral Clearance of PF-05175157 (CL/F)
timeFrame: 0 - 48 hours postdose
measure: Accumulation Ratio of PF-05175157 (Rac)
timeFrame: 0 - 10 hours postdose
measure: Plasma Decay Half-Life of PF-05175157 (t1/2)
timeFrame: 0 - 48 hours postdose
measure: Apparent Volume of Distribution of PF-05175157 (Vz/F)
timeFrame: 0 - 48 hours postdose
measure: Urinary Recovery for PF-05175157 (AE24)
timeFrame: 0 - 24 hours postdose
measure: Renal Clearance for PF-05175157 (CLr)
timeFrame: 0 - 24 hours post dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)]
timeFrame: 0 - 48 hours postdose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)]
timeFrame: 0 - 48 hours postdose
measure: Maximum Observed Plasma Concentration for midazolam (Cmax)
timeFrame: 0 - 48 hours postdose
measure: Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax)
timeFrame: 0 - 48 hours post dose
measure: Plasma Decay Half-Life of midazolam (t1/2)
timeFrame: 0 - 48 hours postdose
measure: Fasting triglycerides
timeFrame: 14 days
measure: Total cholesterol
timeFrame: 14 days
measure: LDL cholesterol
timeFrame: 14 days
measure: HDL cholesterol
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: