Study Stopped
The study was terminated on June 25th, 2009 due to strategic decision
First in Man Study With SLV341
A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV341 in Young Healthy Male Subjects
3 other identifiers
interventional
87
1 country
1
Brief Summary
First in man study with single and multiple rising doses with SLV341
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes
Started Jul 2008
Typical duration for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 30, 2009
CompletedFirst Posted
Study publicly available on registry
April 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedApril 28, 2010
April 1, 2010
10 months
January 30, 2009
April 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solvay Pharmaceuticalslead
- Quintiles, Inc.collaborator
Study Sites (1)
S341.1.001 Site #
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ingrid Meuwsen
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 30, 2009
First Posted
April 24, 2009
Study Start
July 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
April 28, 2010
Record last verified: 2010-04