First in Man Study With SLV342

This study has been terminated.
(Terminated on 14 Sep 2010 due to strategic considerations)
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:
NCT00985478
First received: September 25, 2009
Last updated: August 24, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Pharmacokinetics
Drug: SLV342
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Midazolam PK parameters [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
SLV342 suspension or capsule
Drug: SLV342
25 mg once daily - Maximal Tolerated Dose
Placebo Comparator: B
matching placebo
Drug: placebo
matching placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Healthy

Exclusion Criteria

  • Not healthy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985478

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

No publications provided

Responsible Party: Abbott ( Abbott Products )
ClinicalTrials.gov Identifier: NCT00985478     History of Changes
Other Study ID Numbers: S342.1.001, 2009-014245-88
Study First Received: September 25, 2009
Last Updated: August 24, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Abbott:
First in Man
SLV342
Atherosclerosis

ClinicalTrials.gov processed this record on April 23, 2014