First in Man Study With SLV341

This study has been terminated.
(The study was terminated on June 25th, 2009 due to strategic decision)
Sponsor:
Collaborator:
Quintiles
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00887445
First received: January 30, 2009
Last updated: April 27, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Diabetes
Drug: SLV341
Drug: placebo
Phase 1

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

Enrollment: 87
Study Start Date: July 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: SLV341
5 - 1000mg once daily
Placebo Comparator: B Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria healthy Exclusion Criteria not healthy

  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: NCT00887445

Locations
United Kingdom
S341.1.001 Site #
London, United Kingdom
Sponsors and Collaborators
Solvay Pharmaceuticals
Quintiles
Investigators
Study Director: Ingrid Meuwsen Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00887445     History of Changes
Other Study ID Numbers: S341.1.001, 2007-007196-17, 00887445
Study First Received: January 30, 2009
Last Updated: April 27, 2010
Health Authority: United Kingdom: MHRA - Medicines and Healthcare products Regulatory Agency UK

Keywords provided by Solvay Pharmaceuticals:
First in Man
SLV341
diabetes

ClinicalTrials.gov processed this record on October 19, 2014