First in Man Study With SLV342

• Sponsor: Abbott Products (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00985478
• Collaborator: Quintiles, Inc. (Industry)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Drug: SLV342; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV342 in Young Healthy Male Subjects
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A SLV342 suspension or capsule	Drug: SLV342; 25 mg once daily - Maximal Tolerated Dose
Placebo Comparator: B matching placebo	Drug: placebo; matching placebo

Outcome Measures

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 [28 Days]

Secondary Outcome Measures

1. Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR [28 days]

2. Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring [28 days]

3. Midazolam PK parameters [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Healthy

Exclusion Criteria

• Not healthy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 61142	London		United Kingdom	SE1 1YR

Sponsors and Collaborators

• Abbott Products
• Quintiles, Inc.

Investigators

• Study Director: Ingrid Meuwsen, MS, Abbott Healthcare Products B.V

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Products
• ClinicalTrials.gov Identifier: NCT00985478
• Other Study ID Numbers: S342.1.001; 2009-014245-88
• First Posted: Sep 28, 2009
• Last Update Posted: Aug 25, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by Abbott Products: First in Man; SLV342; Atherosclerosis

Study Results

No Results Posted as of Aug 25, 2011