Multiple Dose Safety Tolerability, 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 Safety, Tolerability, Pharmacokinetics And Effect On Midazolam Pharmacokinetics Of Multiple Oral Doses Of PF-05175157 Administered In A Tablet Formulation In Otherwise Healthy Overweight And Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807377
• Other study ID #: B1731021
• Status: Completed
• Phase: Phase 1
• First received: March 6, 2013
• Last updated: September 16, 2013
• Start date: April 2013
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• 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: 15
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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:

• 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• PF-05175157
200 mg tablet administered twice per day for 14 days
• Midazolam
2mg administered as single doses on Days 0 and 11

Other:
• Placebo
Placebo administered twice per day for 14 days

Drug:
• Midazolam
2mg administered as single doses on Days 0 and 11

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Chula Vista	California

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 PF-05175157 Concentration (Cmax)	Single Dose	0 - 10 hrs postdose	No
Primary	Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau)	Single Dose	0 - 10 hrs postdose	No
Primary	Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)	Single Dose	0 - 10 hrs postdose	No
Primary	Maximum Observed Plasma PF-05175157 Concentration (Cmax)	Steady State	0 - 48 hours postdose	No
Primary	Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157	Steady State	0 - 48 hours postdose	No
Primary	Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)	Steady State	0 - 48 hours postdose	No
Primary	Apparent Oral Clearance of PF-05175157 (CL/F)		0 - 48 hours postdose	No
Primary	Accumulation Ratio of PF-05175157 (Rac)		0 - 10 hours postdose	No
Primary	Plasma Decay Half-Life of PF-05175157 (t1/2)		0 - 48 hours postdose	No
Primary	Apparent Volume of Distribution of PF-05175157 (Vz/F)		0 - 48 hours postdose	No
Primary	Urinary Recovery for PF-05175157 (AE24)	Amount of PF-05175157 recovered in urine over 24 hours	0 - 24 hours postdose	No
Primary	Renal Clearance for PF-05175157 (CLr)		0 - 24 hours post dose	No
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)]		0 - 48 hours postdose	No
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)]		0 - 48 hours postdose	No
Primary	Maximum Observed Plasma Concentration for midazolam (Cmax)		0 - 48 hours postdose	No
Primary	Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax)		0 - 48 hours post dose	No
Primary	Plasma Decay Half-Life of midazolam (t1/2)		0 - 48 hours postdose	No
Primary	Fasting triglycerides		14 days	No
Primary	Total cholesterol		14 days	No
Primary	LDL cholesterol		14 days	No
Primary	HDL cholesterol		14 days	No

External Links

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