First in Man Study With SLV342

Phase 1

Terminated

• Conditions: Pharmacokinetics
• Interventions: Drug: SLV342; Drug: placebo

• Registration Number: NCT00985478
• Lead Sponsor: Abbott Products

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-25
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-28
• Study Start: 2010-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-24
• Last Update Posted: 2011-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	SLV342	SLV342 suspension or capsule
B	placebo	matching placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Site Reference ID/Investigator# 61142; 🇬🇧 London, United Kingdom