MedDataX Logo

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

NCT ID: NCT01707082

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A Cohort 1

Group Type EXPERIMENTAL

PF-06282999

Intervention Type DRUG

Tablet, 10 mg, every 8 hours, 14 days

Placebo

Intervention Type DRUG

Tablet, 0 mg, every 8 hours, 14 days

Part A Cohort 2

Group Type EXPERIMENTAL

PF-06282999

Intervention Type DRUG

Tablet, 30 mg, every 8 hours, 14 days

Placebo

Intervention Type DRUG

Tablet, 0 mg, every 8 hours, 14 days

Part A Cohort 3

Group Type EXPERIMENTAL

PF-06282999

Intervention Type DRUG

Tablet, 100 mg, every 8 hours, 14 days

Placebo

Intervention Type DRUG

Tablet, 0 mg, every 8 hours, 14 days

Part A Cohort 4

Group Type EXPERIMENTAL

PF-06282999

Intervention Type DRUG

Tablet, 250 mg, every 8 hours, 14 days

Placebo

Intervention Type DRUG

Tablet, 0 mg, every 8 hours, 14 days

Part A Cohort 5

Group Type EXPERIMENTAL

PF-06282999

Intervention Type DRUG

Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days

Placebo

Intervention Type DRUG

Tablet, 0 mg, every 8 or 12 hours, 14 days

Part B Cohort 1

Group Type EXPERIMENTAL

midazolam

Intervention Type DRUG

Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14

PF-06282999

Intervention Type DRUG

Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days

Part B Cohort 2

Group Type EXPERIMENTAL

midazolam

Intervention Type DRUG

Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14

PF-06282999

Intervention Type DRUG

Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-06282999

Tablet, 10 mg, every 8 hours, 14 days

Intervention Type DRUG

Placebo

Tablet, 0 mg, every 8 hours, 14 days

Intervention Type DRUG

PF-06282999

Tablet, 30 mg, every 8 hours, 14 days

Intervention Type DRUG

Placebo

Tablet, 0 mg, every 8 hours, 14 days

Intervention Type DRUG

PF-06282999

Tablet, 100 mg, every 8 hours, 14 days

Intervention Type DRUG

Placebo

Tablet, 0 mg, every 8 hours, 14 days

Intervention Type DRUG

PF-06282999

Tablet, 250 mg, every 8 hours, 14 days

Intervention Type DRUG

Placebo

Tablet, 0 mg, every 8 hours, 14 days

Intervention Type DRUG

PF-06282999

Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days

Intervention Type DRUG

Placebo

Tablet, 0 mg, every 8 or 12 hours, 14 days

Intervention Type DRUG

midazolam

Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14

Intervention Type DRUG

PF-06282999

Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days

Intervention Type DRUG

midazolam

Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14

Intervention Type DRUG

PF-06282999

Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5211002&StudyName=A%20Study%20To%20Test%20The%20Safety%2C%20Amount%20And%20Effects%20Of%20PF-06282999%20In%20Healthy%20Overweight%20Adults%20And%20A%20Study%20To%20Test%20The%20Effects%20Of%20

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B5211002

Identifier Type: -

Identifier Source: org_study_id