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

NCT01807377 | Completed Phase 1

• 1 other identifier: B1731021
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (21)

• Maximum Observed Plasma PF-05175157 Concentration (Cmax)

  Single Dose

  0 - 10 hrs postdose

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

  Single Dose

  0 - 10 hrs postdose

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

  Single Dose

  0 - 10 hrs postdose

• Maximum Observed Plasma PF-05175157 Concentration (Cmax)

  Steady State

  0 - 48 hours postdose

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

  Steady State

  0 - 48 hours postdose

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

  Steady State

  0 - 48 hours postdose

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

  0 - 48 hours postdose

• Accumulation Ratio of PF-05175157 (Rac)

  0 - 10 hours postdose

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

  0 - 48 hours postdose

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

  0 - 48 hours postdose

• Urinary Recovery for PF-05175157 (AE24)

  Amount of PF-05175157 recovered in urine over 24 hours

  0 - 24 hours postdose

• Renal Clearance for PF-05175157 (CLr)

  0 - 24 hours post dose

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

  0 - 48 hours postdose

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

  0 - 48 hours postdose

• Maximum Observed Plasma Concentration for midazolam (Cmax)

  0 - 48 hours postdose

• Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax)

  0 - 48 hours post dose

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

  0 - 48 hours postdose

• Fasting triglycerides

  14 days

• Total cholesterol

  14 days

• LDL cholesterol

  14 days

• HDL cholesterol

  14 days

Study Arms (2)

PF-05175157, Midazolam

EXPERIMENTAL

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

Placebo, Midazolam

EXPERIMENTAL

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

Other: Placebo; Drug: Midazolam

Interventions

PF-05175157 DRUG

200 mg tablet administered twice per day for 14 days

PF-05175157, Midazolam

Midazolam DRUG

2mg administered as single doses on Days 0 and 11

PF-05175157, Midazolam

Placebo OTHER

Placebo administered twice per day for 14 days

Placebo, Midazolam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Chula Vista, California, 91911, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 8, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

US (1)