Back to resultsA 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)
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
PF-06282999
Placebo
PF-06282999
Placebo
PF-06282999
Placebo
PF-06282999
Placebo
PF-06282999
Placebo
midazolam
PF-06282999
midazolam
PF-06282999
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part A Cohort 1
Part A Cohort 2
Part A Cohort 3
Part A Cohort 4
Part A Cohort 5
Part B Cohort 1
Part B Cohort 2
Arm Description
Outcomes
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Apparent Oral Clearance (CL/F)
Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Minimum Observed Plasma Trough Concentration (Cmin)
Apparent Oral Clearance (CL/F)
Plasma Decay Half-Life (t1/2)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
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)]
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
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
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
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration (Cmax)
Average Concentration (Cav)
Accumulation Ratio
Secondary Outcome Measures
Diastolic Blood Pressure
Mean 24-hour average diastolic blood pressure
Diastolic Blood Pressure
Mean 24-hour average diastolic blood pressure
Systolic Blood Pressure
Mean 24-hour average systolic blood pressure
Systolic Blood Pressure
Mean 24-hour average systolic blood pressure
interleukin-6
high-sensitivity C-reactive protein
total cholesterol, HDL-C, triglycerides and calculated LDL-C
ApoBTotal,ApoB48, ApoB100, ApoA-1
Diastolic Blood Pressure
Mean 24-hour average diastolic blood pressure
Diastolic Blood Pressure
Mean 24-hour average diastolic blood pressure
Systolic Blood Pressure
Mean 24-hour average systolic blood pressure
Systolic Blood Pressure
Mean 24-hour average systolic blood pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01707082
Brief Title
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
Acronym
B521MAD
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A Cohort 1
Arm Type
Experimental
Arm Title
Part A Cohort 2
Arm Type
Experimental
Arm Title
Part A Cohort 3
Arm Type
Experimental
Arm Title
Part A Cohort 4
Arm Type
Experimental
Arm Title
Part A Cohort 5
Arm Type
Experimental
Arm Title
Part B Cohort 1
Arm Type
Experimental
Arm Title
Part B Cohort 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-06282999
Intervention Description
Tablet, 10 mg, every 8 hours, 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, 0 mg, every 8 hours, 14 days
Intervention Type
Drug
Intervention Name(s)
PF-06282999
Intervention Description
Tablet, 30 mg, every 8 hours, 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, 0 mg, every 8 hours, 14 days
Intervention Type
Drug
Intervention Name(s)
PF-06282999
Intervention Description
Tablet, 100 mg, every 8 hours, 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, 0 mg, every 8 hours, 14 days
Intervention Type
Drug
Intervention Name(s)
PF-06282999
Intervention Description
Tablet, 250 mg, every 8 hours, 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, 0 mg, every 8 hours, 14 days
Intervention Type
Drug
Intervention Name(s)
PF-06282999
Intervention Description
Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, 0 mg, every 8 or 12 hours, 14 days
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
Intervention Type
Drug
Intervention Name(s)
PF-06282999
Intervention Description
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
Intervention Type
Drug
Intervention Name(s)
PF-06282999
Intervention Description
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam
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
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam
Time Frame
-2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Description
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
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
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Description
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
Time Frame
-2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
Title
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
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
Diastolic Blood Pressure
Description
Mean 24-hour average diastolic blood pressure
Time Frame
Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Title
Diastolic Blood Pressure
Description
Mean 24-hour average diastolic blood pressure
Time Frame
Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Title
Systolic Blood Pressure
Description
Mean 24-hour average systolic blood pressure
Time Frame
Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Title
Systolic Blood Pressure
Description
Mean 24-hour average systolic blood pressure
Time Frame
Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Title
interleukin-6
Time Frame
Days 1 and 14 pre-dose Part A
Title
high-sensitivity C-reactive protein
Time Frame
Days 1 and 14 pre-dose Part A
Title
total cholesterol, HDL-C, triglycerides and calculated LDL-C
Time Frame
Days 1 and 14 pre-dose Part A
Title
ApoBTotal,ApoB48, ApoB100, ApoA-1
Time Frame
Days 1 and 14 pre-dose Part A
Title
Diastolic Blood Pressure
Description
Mean 24-hour average diastolic blood pressure
Time Frame
Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Title
Diastolic Blood Pressure
Description
Mean 24-hour average diastolic blood pressure
Time Frame
Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Title
Systolic Blood Pressure
Description
Mean 24-hour average systolic blood pressure
Time Frame
Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Title
Systolic Blood Pressure
Description
Mean 24-hour average systolic blood pressure
Time Frame
Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
12. IPD Sharing Statement
Links:
URL
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
Description
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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
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