A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy Volunteers
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00736606
First received: August 15, 2008
Last updated: November 30, 2010
Last verified: November 2010
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Purpose
The purpose of the study is to assess the pharmacokinetics of both AZD9056 (steady state) and simvastatin (single dose) when co-administered in healthy volunteers
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: simvastatin Drug: AZD9056 + simvastatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Phase I, Single Centre, Open-Label Study to Assess the Pharmacokinetics of Both AZD9056 (Steady State) and Simvastatin (Single Dose) When Co-Administered in Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- PK variables [ Time Frame: Frequent sampling occasions during study periods ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment periods ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 12 |
| Study Start Date: | August 2008 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Period 1
simvastatin
|
Drug: simvastatin
One single dose of 40mg
Other Name: Zocor
|
|
Experimental: Period 2
simvastatin + AZD9056
|
Drug: AZD9056 + simvastatin
AZD9056: 400 mg od, 8 days simvastatin: one single dose of 40 mg on day 7
Other Name: Zocor
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures.
- Male or female healthy subjects. Females should not be of childbearing potential
- Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results
Exclusion Criteria:
- Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
- Known allergy to simvastatin (or other statins) or previous complications to simvastatin therapy.
- Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736606
Locations
| Germany | |
| Research Site | |
| Berlin, Germany | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Rod Hepburn | AstraZeneca R&D, Charnwood, UK |
| Principal Investigator: | Maura Fallon | PAREXEL Clinical Pharmacology Research Unit |
More Information
No publications provided
| Responsible Party: | Mark Layton, MD, PhD, Medical Science Director, AstraZeneca R&D Alderely Park |
| ClinicalTrials.gov Identifier: | NCT00736606 History of Changes |
| Other Study ID Numbers: | D1520C00008, EudraCt nr 2008-003626-41 |
| Study First Received: | August 15, 2008 |
| Last Updated: | November 30, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by AstraZeneca:
|
simvastatin AZD5672 |
Additional relevant MeSH terms:
|
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 May 16, 2013