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CompletedNCT01807377Updated Sep 17, 2013

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

A Phase 1 interventional study of PF-05175157 and Midazolam in Diabetes Mellitus Type 2, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-17.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diabetes Mellitus Type 2
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 15 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    PF-05175157, Midazolam

    Day 0: Midazolam 2 mg administered alone Days 1-14: 200 mg PF-05175157 administered BID Day 11: Midazolam and PF-05175157

    Drug: PF-05175157 · Drug: Midazolam

  • Experimental
    Placebo, Midazolam

    Day 0: Midazolam 2 mg administered alone Days 1-14: Placebo administered BID Day 11: Midazolam and Placebo

    Other: Placebo · Drug: Midazolam

Interventions

  • DrugPF-05175157

    200 mg tablet administered twice per day for 14 days

  • DrugMidazolam

    2mg administered as single doses on Days 0 and 11

  • OtherPlacebo

    Placebo administered twice per day for 14 days

  • DrugMidazolam

    2mg administered as single doses on Days 0 and 11

06

What researchers measure

Primary outcomes

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

    Single Dose

    Time frame: 0 - 10 hrs postdose

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

    Single Dose

    Time frame: 0 - 10 hrs postdose

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

    Single Dose

    Time frame: 0 - 10 hrs postdose

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

    Steady State

    Time frame: 0 - 48 hours postdose

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

    Steady State

    Time frame: 0 - 48 hours postdose

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

    Steady State

    Time frame: 0 - 48 hours postdose

  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)

    Amount of PF-05175157 recovered in urine over 24 hours

    Time frame: 0 - 24 hours postdose

  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

07

Study locations

1 site
  • Pfizer Investigational Site
    Chula Vista, California 91911, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01807377
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Mar 8, 2013
Start date
Apr 2013
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Sep 17, 2013

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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