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

Diabetes Mellitus, Type 2 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757756
• Other study ID #: B1731017
• Status: Completed
• Phase: Phase 1
• First received: October 23, 2012
• Last updated: December 21, 2012
• Start date: October 2012
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• Pf-05175157
200-mg administered twice daily for 14 days
• placebo
placebo administered twice daily for 14 days
• midazolam
midazolam 3-mg admistered as single doses on Day 0 and Day 11.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose	No
Primary	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	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose	No
Primary	Maximum Observed Plasma Concentration (Cmax)		0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose	No
Primary	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	No
Primary	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	No
Primary	Plasma Decay Half-Life (t1/2)		0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose	No
Primary	Apparent Volume of Distribution (Vz/F)		0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose	No
Primary	Apparent Oral Clearance (CL/F)		0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose	No
Primary	Accumulation Ratio (Rac)		0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours postdose	No
Primary	Ae,tau		0-12 hr	No
Primary	Ae%		0-12 hr	No
Primary	Clr		0-12 hr	No
Primary	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	No
Primary	Maximum Observed Plasma Concentration (Cmax)		0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours	No
Primary	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	No
Primary	Plasma Decay Half-Life (t1/2)		0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours	No
Primary	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	No
Primary	fasting triglycerides		14 days	No
Primary	fasting LDL-cholesterol		14 days	No
Primary	fasting total cholesterol		14 days	No
Primary	fasting HDL cholesterol		14 days	No

External Links

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