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Interaction Study SLV337/Simvastatin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00924430
First Posted: June 19, 2009
Last Update Posted: September 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solvay Pharmaceuticals
  Purpose
To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin and simvastatin acid when co-administered in healthy male subjects

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin Drug: Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Drug Interaction Study to Investigate the Effects of SLV337 on the Pharmacokinetics of Simvastatin and Simvastatin Acid in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Simvastatin and simvastatin acid: Cmax, tmax, AUC0-t, AUC, lz, and t1/2, as well as CL/F and Vz/F for simvastatin only [ Time Frame: 20 days ]

Secondary Outcome Measures:
  • SLV337 and its acylglucuronide metabolite: Cmax, tmax, AUC0-24, AUC0-t, CL/F (SLV337 only) on Days 1 and 13, as well as AUC, lz, t1/2 and Vz/F (SLV337 only) on Day 1 [ Time Frame: 20 days ]
  • Safety and tolerability assessments including adverse events, clinical laboratory tests, electrocardiogram (ECG) and vital signs [ Time Frame: During the duration of study participation ]

Enrollment: 16
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin
Single dose of 40 mg simvastatin tablet, single dose of 1400 mg SLV337 beta capsule, single dose of 1400 mg SLV337 alpha capsule, multiple dose over 12 days of 1400 mg/day SLV337 beta capsule including a single dose of 40 mg simvastatin tablet before the last dosing day
2 Drug: Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin
Single dose of 40 mg simvastatin tablet, single dose of 1400 mg SLV337 alpha capsule, single dose of 1400 mg SLV337 beta capsule, multiple dose over 12 days of 1400 mg/day SLV337 beta capsule including a single dose of 40 mg simvastatin tablet before the last dosing day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers with Body Mass Index 18.0-28.0 kg/m2

Exclusion Criteria:

  • Clinically relevant medical history
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924430


Locations
United Kingdom
Site 1
London, United Kingdom
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Responsible Party: Claire Nee, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00924430     History of Changes
Other Study ID Numbers: S337.1.002
2009-010392-24
First Submitted: May 19, 2009
First Posted: June 19, 2009
Last Update Posted: September 9, 2009
Last Verified: September 2009

Keywords provided by Solvay Pharmaceuticals:
Interaction SLV337 and simvastatin
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors