Interaction Study SLV337/Simvastatin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Drug Interaction Study to Investigate the Effects of SLV337 on the Pharmacokinetics of Simvastatin and Simvastatin Acid in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924430
• Other study ID #: S337.1.002
• Secondary ID: 2009-010392-24
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2009
• Last updated: September 4, 2009
• Start date: June 2009
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin and simvastatin acid when co-administered in healthy male subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Clinically relevant medical history

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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
• 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

Locations

Country	Name	City	State
United Kingdom	Site 1	London

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simvastatin and simvastatin acid: Cmax, tmax, AUC0-t, AUC, lz, and t1/2, as well as CL/F and Vz/F for simvastatin only		20 days	No
Secondary	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		20 days	No
Secondary	Safety and tolerability assessments including adverse events, clinical laboratory tests, electrocardiogram (ECG) and vital signs		During the duration of study participation	No