A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults (B521MAD)

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: PF-06282999

Drug: Placebo

Drug: midazolam

Study type

Interventional

Funder types

Industry

Identifiers

NCT01707082

B5211002

Details and patient eligibility

About

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.

Enrollment

69 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

69 participants in 7 patient groups

Part A Cohort 1

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06282999

Drug: Placebo

Drug: PF-06282999

Drug: Placebo

Part A Cohort 2

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06282999

Drug: Placebo

Drug: PF-06282999

Drug: Placebo

Part A Cohort 3

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06282999

Drug: Placebo

Drug: PF-06282999

Drug: Placebo

Part A Cohort 4

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06282999

Drug: Placebo

Drug: PF-06282999

Drug: Placebo

Part A Cohort 5

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06282999

Drug: Placebo

Drug: PF-06282999

Drug: Placebo

Part B Cohort 1

Experimental group

Treatment:

Drug: PF-06282999

Drug: midazolam

Drug: PF-06282999

Drug: midazolam

Drug: PF-06282999

Part B Cohort 2

Experimental group

Treatment:

Drug: PF-06282999

Drug: midazolam

Drug: PF-06282999

Drug: midazolam

Drug: PF-06282999

Trial contacts and locations

1

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