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Completed

NCT Number: NCT01807377

Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects

This study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of PF-05175157 administered twice daily for 14 days in healthy overweight and obese subjects.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

  • 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 25 to 35 kg/m2 inclusive; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Evidence or history of any chronic ongoing or current pulmonary disease.
  • History of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products. Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.

Treatment and study plan

PF-05175157

Drug

200 mg tablet administered twice per day for 14 days

midazolam

Drug

2mg administered as single doses on Days 0 and 11

Placebo

Other

Placebo administered twice per day for 14 days

Primary outcomes

  1. Maximum Observed Plasma PF-05175157 Concentration (Cmax)

    Time frame: 0 - 10 hrs postdose

    Single Dose

  2. Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau)

    Time frame: 0 - 10 hrs postdose

    Single Dose

  3. Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)

    Time frame: 0 - 10 hrs postdose

    Single Dose

  4. Maximum Observed Plasma PF-05175157 Concentration (Cmax)

    Time frame: 0 - 48 hours postdose

    Steady State

  5. Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157

    Time frame: 0 - 48 hours postdose

    Steady State

  6. Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)

    Time frame: 0 - 48 hours postdose

    Steady State

  7. Apparent Oral Clearance of PF-05175157 (CL/F)

    Time frame: 0 - 48 hours postdose

  8. Accumulation Ratio of PF-05175157 (Rac)

    Time frame: 0 - 10 hours postdose

  9. Plasma Decay Half-Life of PF-05175157 (t1/2)

    Time frame: 0 - 48 hours postdose

  10. Apparent Volume of Distribution of PF-05175157 (Vz/F)

    Time frame: 0 - 48 hours postdose

  11. Urinary Recovery for PF-05175157 (AE24)

    Time frame: 0 - 24 hours postdose

    Amount of PF-05175157 recovered in urine over 24 hours

  12. Renal Clearance for PF-05175157 (CLr)

    Time frame: 0 - 24 hours post dose

  13. Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)]

    Time frame: 0 - 48 hours postdose

  14. Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)]

    Time frame: 0 - 48 hours postdose

  15. Maximum Observed Plasma Concentration for midazolam (Cmax)

    Time frame: 0 - 48 hours postdose

  16. Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax)

    Time frame: 0 - 48 hours post dose

  17. Plasma Decay Half-Life of midazolam (t1/2)

    Time frame: 0 - 48 hours postdose

  18. Fasting triglycerides

    Time frame: 14 days

  19. Total cholesterol

    Time frame: 14 days

  20. LDL cholesterol

    Time frame: 14 days

  21. HDL cholesterol

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1 Placebo-Controlled Study To Assess Safety, Tolerability, Pharmacokinetics And Effect On Midazolam Pharmacokinetics Of Multiple Oral Doses Of PF-05175157 Administered In A Tablet Formulation In Otherwise Healthy Overweight And Obese Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2013
Registry last updated
Sep 17, 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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