Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01807377
First received: March 6, 2013
Last updated: May 6, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Type 2 |
Drug: PF-05175157 Drug: Midazolam Other: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Maximum Observed Plasma PF-05175157 Concentration (Cmax) [ Time Frame: 0 - 10 hrs postdose ] [ Designated as safety issue: No ]
- Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau) [ Time Frame: 0 - 10 hrs postdose ] [ Designated as safety issue: No ]
- Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) [ Time Frame: 0 - 10 hrs postdose ] [ Designated as safety issue: No ]
- Maximum Observed Plasma PF-05175157 Concentration (Cmax) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
- Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157 [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
- Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
- Apparent Oral Clearance of PF-05175157 (CL/F) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
- Accumulation Ratio of PF-05175157 (Rac) [ Time Frame: 0 - 10 hours postdose ] [ Designated as safety issue: No ]
- Plasma Decay Half-Life of PF-05175157 (t1/2) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
- Apparent Volume of Distribution of PF-05175157 (Vz/F) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
- Urinary Recovery for PF-05175157 (AE24) [ Time Frame: 0 - 24 hours postdose ] [ Designated as safety issue: No ]
- Renal Clearance for PF-05175157 (CLr) [ Time Frame: 0 - 24 hours post dose ] [ Designated as safety issue: No ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)] [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
- Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)] [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
- Maximum Observed Plasma Concentration for midazolam (Cmax) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
- Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax) [ Time Frame: 0 - 48 hours post dose ] [ Designated as safety issue: No ]
- Plasma Decay Half-Life of midazolam (t1/2) [ Time Frame: 0 - 48 hours postdose ] [ Designated as safety issue: No ]
- Fasting triglycerides [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Total cholesterol [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- LDL cholesterol [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- HDL cholesterol [ Time Frame: 14 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
200 mg tablet administered twice per day for 14 days
Drug: Midazolam
2mg administered as single doses on Days 0 and 11
|
|
Experimental: Placebo, Midazolam
Day 0: Midazolam 2 mg administered alone Days 1-14: Placebo administered BID Day 11: Midazolam and Placebo
|
Other: Placebo
Placebo administered twice per day for 14 days
Drug: Midazolam
2mg administered as single doses on Days 0 and 11
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01807377
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, California | |
| Pfizer Investigational Site | Recruiting |
| Chula Vista, California, United States, 91911 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01807377 History of Changes |
| Other Study ID Numbers: | B1731021 |
| Study First Received: | March 6, 2013 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Overweight Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Body Weight Signs and Symptoms Midazolam Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013