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First in Man Study With SLV341

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ClinicalTrials.gov Identifier: NCT00887445
Recruitment Status : Terminated (The study was terminated on June 25th, 2009 due to strategic decision)
First Posted : April 24, 2009
Last Update Posted : April 28, 2010
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
First in man study with single and multiple rising doses with SLV341

Condition or disease Intervention/treatment Phase
Diabetes Drug: SLV341 Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: A Drug: SLV341
5 - 1000mg once daily
Placebo Comparator: B Drug: placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR [ Time Frame: 1 - 28 days ]
  2. Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring. [ Time Frame: 28 days ]
  3. Interaction with Midazolam [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
Inclusion Criteria healthy Exclusion Criteria not healthy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887445


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

ClinicalTrials.gov Identifier: NCT00887445     History of Changes
Other Study ID Numbers: S341.1.001
2007-007196-17
00887445
First Posted: April 24, 2009    Key Record Dates
Last Update Posted: April 28, 2010
Last Verified: April 2010

Keywords provided by Solvay Pharmaceuticals:
First in Man
SLV341
diabetes