First in Man Study With SLV341

Diabetes Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV341 in Young Healthy Male Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00887445
• Other study ID #: S341.1.001
• Secondary ID: 2007-007196-1700
• Status: Terminated
• Phase: Phase 1
• First received: January 30, 2009
• Last updated: April 27, 2010
• Start date: July 2008
• Est. completion date: May 2009

Study information

• Verified date: April 2010
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: MHRA - Medicines and Healthcare products Regulatory Agency UK
• Study type: Interventional

Clinical Trial Summary

First in man study with single and multiple rising doses with SLV341

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years
• Eligibility: Inclusion Criteria healthy Exclusion Criteria not healthy

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• SLV341
5 - 1000mg once daily
• placebo

Locations

Country	Name	City	State
United Kingdom	S341.1.001 Site #	London

Sponsors (2)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals	Quintiles, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination.		7 days	No
Secondary	Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, ?z, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR		1 - 28 days	No
Secondary	Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring.		28 days	No
Secondary	Interaction with Midazolam		24 hours	No