First in Man Study With SLV342

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00985478
Recruitment Status : Terminated (Terminated on 14 Sep 2010 due to strategic considerations)
First Posted : September 28, 2009
Last Update Posted : August 25, 2011
Quintiles, Inc.
Information provided by (Responsible Party):
Abbott ( Abbott Products )

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 Type : Interventional  (Clinical Trial)
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 : January 2010
Primary Completion Date : June 2010
Study Completion Date : June 2010

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

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 [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR [ Time Frame: 28 days ]
  2. Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring [ Time Frame: 28 days ]
  3. Midazolam PK parameters [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • Healthy

Exclusion Criteria

  • Not healthy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00985478

United Kingdom
Site Reference ID/Investigator# 61142
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
Abbott Products
Quintiles, Inc.
Study Director: Ingrid Meuwsen, MS Abbott Healthcare Products B.V

Responsible Party: Abbott Products Identifier: NCT00985478     History of Changes
Other Study ID Numbers: S342.1.001
2009-014245-88 ( EudraCT Number )
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: August 25, 2011
Last Verified: August 2011

Keywords provided by Abbott ( Abbott Products ):
First in Man