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NCT00985478 Clinical Trial

First in Man Study With SLV342

Pharmacokinetics Clinical Trial

Official title:
A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV342 in Young Healthy Male Subjects

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00985478
Other study ID # S342.1.001
Secondary ID 2009-014245-88
Status Terminated
Phase Phase 1
First received September 25, 2009
Last updated August 24, 2011
Start date January 2010
Est. completion date June 2010

Study information
Verified date August 2011
Source Abbott
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

First in man study with single and multiple rising doses with SLV342

Recruitment information / eligibility
Status Terminated
Enrollment 48
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria

- Healthy

Exclusion Criteria

- Not healthy

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SLV342
25 mg once daily - Maximal Tolerated Dose
• placebo
matching placebo

Locations
Country Name City State
United Kingdom Site Reference ID/Investigator# 61142 London

Sponsors (2)
Lead Sponsor Collaborator
Abbott Products Quintiles, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination 28 Days Yes
Secondary Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, ?z, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR 28 days No
Secondary Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring 28 days No
Secondary Midazolam PK parameters 24 hours No
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