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)

July 29, 2013 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A Cohort 1
Drug: PF-06282999
Tablet, 10 mg, every 8 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 30 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 100 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 250 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 or 12 hours, 14 days
Drug: PF-06282999
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
Experimental: Part A Cohort 2
Drug: PF-06282999
Tablet, 10 mg, every 8 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 30 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 100 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 250 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 or 12 hours, 14 days
Drug: PF-06282999
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
Experimental: Part A Cohort 3
Drug: PF-06282999
Tablet, 10 mg, every 8 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 30 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 100 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 250 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 or 12 hours, 14 days
Drug: PF-06282999
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
Experimental: Part A Cohort 4
Drug: PF-06282999
Tablet, 10 mg, every 8 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 30 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 100 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 250 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 or 12 hours, 14 days
Drug: PF-06282999
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
Experimental: Part A Cohort 5
Drug: PF-06282999
Tablet, 10 mg, every 8 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 30 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 100 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 250 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 or 12 hours, 14 days
Drug: PF-06282999
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
Experimental: Part B Cohort 1
Drug: PF-06282999
Tablet, 10 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 30 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 100 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 250 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days
Drug: PF-06282999
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
Drug: midazolam
Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
Experimental: Part B Cohort 2
Drug: PF-06282999
Tablet, 10 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 30 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 100 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 250 mg, every 8 hours, 14 days
Drug: PF-06282999
Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days
Drug: PF-06282999
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
Drug: midazolam
Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 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 and 16 hrs post morning dose Day 1 Part A
Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Apparent Oral Clearance (CL/F)
Time Frame: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Maximum Observed Plasma Concentration (Cmax)
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
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
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
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
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
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
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
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: Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam
Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
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
-2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time Frame: Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 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
Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
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
-2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
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
-2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
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
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diastolic Blood Pressure
Time Frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Mean 24-hour average diastolic blood pressure
Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Diastolic Blood Pressure
Time Frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Mean 24-hour average diastolic blood pressure
Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Systolic Blood Pressure
Time Frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Mean 24-hour average systolic blood pressure
Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Systolic Blood Pressure
Time Frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Mean 24-hour average systolic blood pressure
Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
interleukin-6
Time Frame: Days 1 and 14 pre-dose Part A
Days 1 and 14 pre-dose Part A
high-sensitivity C-reactive protein
Time Frame: Days 1 and 14 pre-dose Part A
Days 1 and 14 pre-dose Part A
total cholesterol, HDL-C, triglycerides and calculated LDL-C
Time Frame: Days 1 and 14 pre-dose Part A
Days 1 and 14 pre-dose Part A
ApoBTotal,ApoB48, ApoB100, ApoA-1
Time Frame: Days 1 and 14 pre-dose Part A
Days 1 and 14 pre-dose Part A
Diastolic Blood Pressure
Time Frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Mean 24-hour average diastolic blood pressure
Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Diastolic Blood Pressure
Time Frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Mean 24-hour average diastolic blood pressure
Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Systolic Blood Pressure
Time Frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Mean 24-hour average systolic blood pressure
Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Systolic Blood Pressure
Time Frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Mean 24-hour average systolic blood pressure
Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B5211002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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