First in Man Study With SLV341

Phase 1

Terminated

• Conditions: Diabetes
• Interventions: Drug: SLV341; Drug: placebo

• Registration Number: NCT00887445
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-27
• Last Update Posted: 2010-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 87

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	SLV341	-
B	placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination.	7 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR	1 - 28 days
Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring.	28 days
Interaction with Midazolam	24 hours

Trial Locations

Locations (1)

S341.1.001 Site #; 🇬🇧 London, United Kingdom