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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014