Study Stopped
Terminated on 14 Sep 2010 due to strategic considerations
First in Man Study With SLV342
A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV342 in Young Healthy Male Subjects
2 other identifiers
interventional
48
1 country
1
Brief Summary
First in man study with single and multiple rising doses with SLV342
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2010
Shorter than P25 for phase_1
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
First Submitted
Initial submission to the registry
September 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedAugust 25, 2011
August 1, 2011
5 months
September 25, 2009
August 24, 2011
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
28 Days
Secondary Outcomes (3)
Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR
28 days
Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring
28 days
Midazolam PK parameters
24 hours
Study Arms (2)
A
EXPERIMENTALSLV342 suspension or capsule
B
PLACEBO COMPARATORmatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- Healthy
You may not qualify if:
- Not healthy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Productslead
- Quintiles, Inc.collaborator
Study Sites (1)
Site Reference ID/Investigator# 61142
London, SE1 1YR, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ingrid Meuwsen, MS
Abbott Healthcare Products B.V
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2009
First Posted
September 28, 2009
Study Start
January 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
August 25, 2011
Record last verified: 2011-08