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Completed

NCT Number: NCT01707082

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-06282999

Drug

Tablet, 10 mg, every 8 hours, 14 days

Placebo

Drug

Tablet, 0 mg, every 8 hours, 14 days

midazolam

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. interleukin-6

    Time frame: Days 1 and 14 pre-dose Part A

  6. high-sensitivity C-reactive protein

    Time frame: Days 1 and 14 pre-dose Part A

  7. total cholesterol, HDL-C, triglycerides and calculated LDL-C

    Time frame: Days 1 and 14 pre-dose Part A

  8. ApoBTotal,ApoB48, ApoB100, ApoA-1

    Time frame: Days 1 and 14 pre-dose Part A

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: B521MAD

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 15, 2012
Registry last updated
Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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