A Study To Estimate The Effect Of Repeated Dosing of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01469468
First received: October 29, 2011
Last updated: December 27, 2011
Last verified: December 2011
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Purpose
The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Simvastatin Drug: PF-05175157 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Area under the plasma concentration curve of simvastatin and simvastatin acid [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- Maximum observed plasma concentration of simvastatin and simvastatin acid [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- If the data permit, terminal elimination half-life of simvastatin and simvastatin acid [ Time Frame: 10 days ] [ Designated as safety issue: No ]
| Enrollment: | 14 |
| Study Start Date: | November 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single arm, fixed sequence dosing |
Drug: Simvastatin
Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157)
Drug: PF-05175157
Days 2-9 inclusive: daily dosing of PF-05175157 200 mg
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy subjects with normal results in all screening examinations.
- Body Mass Index of 17.5 to 35.5 kg/m2
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, ocular, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Known history of intolerance to simvastatin or other statins.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01469468 History of Changes |
| Other Study ID Numbers: | B1731012 |
| Study First Received: | October 29, 2011 |
| Last Updated: | December 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Simvastatin Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013