First in Man Study With SLV341

This study is currently recruiting participants.

Verified by Solvay Pharmaceuticals, April 2009

First Received: January 30, 2009 Last Updated: April 23, 2009 History of Changes

Sponsors and Collaborators:	Solvay Pharmaceuticals Quintiles
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00887445

Purpose

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

Condition	Intervention	Phase
Diabetes	Drug: SLV341 Drug: Placebo	Phase I

MedlinePlus related topics: Diabetes

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV341 in Young Healthy Male Subjects

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR [ Time Frame: 1-28 days ] [ Designated as safety issue: No ]
Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Interaction with Midazolam [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	110
Study Start Date:	September 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: SLV341 5 - 1000mg once daily
B: Placebo Comparator	Drug: Placebo Placebo

Eligibility

Criteria

Inclusion criteria: - Healthy Exclusion criteria: - Not Healthy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887445

Contacts

Contact: Ingrid Meuwsen

Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Quintiles

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Ingrid Meuwsen )
Study ID Numbers:	S341.1.001, 2007-007196-17
Study First Received:	January 30, 2009
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00887445 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Solvay Pharmaceuticals:

First in Man
SLV341
diabetes

Study placed in the following topic categories:

Diabetes Mellitus
Healthy

ClinicalTrials.gov processed this record on May 06, 2009