Clinical Trials/NCT01707082

NCT01707082

Completed

Phase 1

A Phase 1, Randomized, Placebo-Controlled, Multiple Dose Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of PF-06282999 In Healthy Overweight Subjects And A Fixed-Sequence Study To Assess The Effect Of PF-06282999 On The Pharmacokinetics Of Midazolam In Healthy Subjects

Pfizer1 site in 1 country69 target enrollmentOctober 2012

ConditionsHealthy

InterventionsPF-06282999 Placebo midazolam

DrugsPF-06282999 Placebo midazolam

Overview

Phase: Phase 1
Intervention: PF-06282999
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 69
Locations: 1
Primary Endpoint: Maximum Observed Plasma Concentration (Cmax)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Part A of the study will test the safety, the amount of drug in the body, and effects of the drug in the body after multiple doses. This will be conducted in healthy overweight adults. Part B of the study will test the effects of multiple doses of the investigational drug on the amount of midazolam, an approved drug, in healthy adults.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

May 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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). Women must be of non childbearing potential.
•Body Mass Index (BMI) of 27.0 to 35.0 kg/m2 (Part A) or 17.5 to 30.5 kg/m2 (Part B); and a total body weight \>50 kg (110 lbs).

Exclusion Criteria

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
•Subject with any contraindication to midazolam according to the country specific labeling or subject with previous intolerance or allergy to benzodiazepines (applicable to Part B of study only).
•Subjects who were enrolled in Part A are excluded from participation in Part B of this study.
•Subjects who have previously participated in a study with PF-06282999.

Arms & Interventions

Part A Cohort 1

Intervention: PF-06282999

Part A Cohort 1

Intervention: Placebo

Part A Cohort 2

Intervention: PF-06282999

Part A Cohort 2

Intervention: Placebo

Part A Cohort 3

Intervention: PF-06282999

Part A Cohort 3

Intervention: Placebo

Part A Cohort 4

Intervention: PF-06282999

Part A Cohort 4

Intervention: Placebo

Part A Cohort 5

Intervention: PF-06282999

Part A Cohort 5

Intervention: Placebo

Part B Cohort 1

Intervention: midazolam

Part B Cohort 1

Intervention: PF-06282999

Part B Cohort 2

Intervention: midazolam

Part B Cohort 2

Intervention: PF-06282999

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax)

Time Frame: -2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time Frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A

Area Under the Curve from Time Zero to end of dosing interval (AUCtau)

Time Frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A

Apparent Oral Clearance (CL/F)

Time Frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A

Minimum Observed Plasma Trough Concentration (Cmin)

Time Frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A

Plasma Decay Half-Life (t1/2)

Time Frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Time Frame: -2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

Time Frame: -2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B

AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). Midazolam

Average Concentration (Cav)

Time Frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A

Accumulation Ratio

Time Frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A

Secondary Outcomes

Diastolic Blood Pressure(Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B)
Systolic Blood Pressure(Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B)
interleukin-6(Days 1 and 14 pre-dose Part A)
high-sensitivity C-reactive protein(Days 1 and 14 pre-dose Part A)
total cholesterol, HDL-C, triglycerides and calculated LDL-C(Days 1 and 14 pre-dose Part A)
ApoBTotal,ApoB48, ApoB100, ApoA-1(Days 1 and 14 pre-dose Part A)