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Completed

NCT Number: NCT01757756

Multiple Dose Safety Toelrability, 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 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

South Miami, Florida, 33143, United States

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).
  • Body Mass Index (BMI) of 25 to 35 kg/m2 inclusive; and a total body weight >50 kg (110 lbs).
  • 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 administered twice daily for 14 days

Placebo

Drug

placebo administered twice daily for 14 days

midazolam

Drug

midazolam 3-mg admistered as single doses on Day 0 and Day 11.

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose

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

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose

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

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose

  4. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose

  5. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose

  6. Area Under the Curve from Time Zero to end of dosing interval (AUCtau)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose

  7. Plasma Decay Half-Life (t1/2)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose

  8. Apparent Volume of Distribution (Vz/F)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose

  9. Apparent Oral Clearance (CL/F)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose

  10. Accumulation Ratio (Rac)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours postdose

  11. Ae,tau

    Time frame: 0-12 hr

  12. Ae%

    Time frame: 0-12 hr

  13. Clr

    Time frame: 0-12 hr

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

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours

  15. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours

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

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours

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

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours

  18. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours

  19. fasting triglycerides

    Time frame: 14 days

  20. fasting LDL-cholesterol

    Time frame: 14 days

  21. fasting total cholesterol

    Time frame: 14 days

  22. fasting 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 The Safety, Tolerability, Pharmacokinetics And Effect On Midazolam Pharmacokinetics Of Multiple Oral Doses Of PF-05175157 In Otherwise Healthy Overweight And Obese Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 31, 2012
Registry last updated
Dec 31, 2012

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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