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)
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01707082
First received: October 3, 2012
Last updated: May 12, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-06282999 Drug: Placebo Drug: midazolam |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Diastolic Blood Pressure [ Time Frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A ] [ Designated as safety issue: No ]
- Diastolic Blood Pressure [ Time Frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A ] [ Designated as safety issue: No ]
- Systolic Blood Pressure [ Time Frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A ] [ Designated as safety issue: No ]
- Systolic Blood Pressure [ Time Frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A ] [ Designated as safety issue: No ]
- interleukin-6 [ Time Frame: Days 1 and 14 pre-dose Part A ] [ Designated as safety issue: No ]
- high-sensitivity C-reactive protein [ Time Frame: Days 1 and 14 pre-dose Part A ] [ Designated as safety issue: No ]
- total cholesterol, HDL-C, triglycerides and calculated LDL-C [ Time Frame: Days 1 and 14 pre-dose Part A ] [ Designated as safety issue: No ]
- ApoBTotal,ApoB48, ApoB100, ApoA-1 [ Time Frame: Days 1 and 14 pre-dose Part A ] [ Designated as safety issue: No ]
- Diastolic Blood Pressure [ Time Frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B ] [ Designated as safety issue: No ]
- Diastolic Blood Pressure [ Time Frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B ] [ Designated as safety issue: No ]
- Systolic Blood Pressure [ Time Frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B ] [ Designated as safety issue: No ]
- Systolic Blood Pressure [ Time Frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 68 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
| Experimental: Part A Cohort 2 |
Drug: PF-06282999
Tablet, 30 mg, every 8 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 hours, 14 days
|
| Experimental: Part A Cohort 3 |
Drug: PF-06282999
Tablet, 100 mg, every 8 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 hours, 14 days
|
| Experimental: Part A Cohort 4 |
Drug: PF-06282999
Tablet, 250 mg, every 8 hours, 14 days
Drug: Placebo
Tablet, 0 mg, every 8 hours, 14 days
|
| Experimental: Part A Cohort 5 |
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
|
| Experimental: Part B Cohort 1 |
Drug: midazolam
Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
Drug: PF-06282999
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
|
| Experimental: Part B Cohort 2 |
Drug: midazolam
Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
Drug: PF-06282999
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707082
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Belgium | |
| Pfizer Investigational Site | Recruiting |
| Bruxelles, Belgium, B-1070 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01707082 History of Changes |
| Other Study ID Numbers: | B5211002 |
| Study First Received: | October 3, 2012 |
| Last Updated: | May 12, 2013 |
| Health Authority: | European Union: European Medicines Agency |
Additional relevant MeSH terms:
|
Overweight Body Weight Signs and Symptoms Midazolam Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013