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

NCT01757756 | Completed Phase 1

• 1 other identifier: B1731017
• Study Type: interventional
• Target: 12
• 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; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (22)

• Maximum Observed Plasma Concentration (Cmax)

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

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

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

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

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

• Maximum Observed Plasma Concentration (Cmax)

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

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

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

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

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

• Plasma Decay Half-Life (t1/2)

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

• Apparent Volume of Distribution (Vz/F)

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

• Apparent Oral Clearance (CL/F)

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

• Accumulation Ratio (Rac)

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

• Ae,tau

  0-12 hr

• Ae%

  0-12 hr

• Clr

  0-12 hr

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

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

• Maximum Observed Plasma Concentration (Cmax)

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

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

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

• Plasma Decay Half-Life (t1/2)

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

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

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

• fasting triglycerides

  14 days

• fasting LDL-cholesterol

  14 days

• fasting total cholesterol

  14 days

• fasting HDL cholesterol

  14 days

Study Arms (1)

Arm Label Pf-05175157, placebo, midazolam

EXPERIMENTAL

Drug: Pf-05175157; Drug: placebo; Drug: midazolam

Interventions

Pf-05175157 DRUG

200-mg administered twice daily for 14 days

Arm Label Pf-05175157, placebo, midazolam

placebo DRUG

placebo administered twice daily for 14 days

Arm Label Pf-05175157, placebo, midazolam

midazolam DRUG

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

Arm Label Pf-05175157, 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).
• 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.

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

South Miami, Florida, 33143, United States

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

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: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: December 31, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 31, 2012

Record last verified: 2012-12

Locations

US (1)