Interaction Study SLV337/Simvastatin

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00924430
First received: May 19, 2009
Last updated: September 4, 2009
Last verified: September 2009
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Safety and tolerability assessments including adverse events, clinical laboratory tests, electrocardiogram (ECG) and vital signs [ Time Frame: During the duration of study participation ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Claire Nee, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00924430     History of Changes
Other Study ID Numbers: S337.1.002, 2009-010392-24
Study First Received: May 19, 2009
Last Updated: September 4, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 16, 2014