First in Man Study With SLV341

April 27, 2010 updated by: Solvay Pharmaceuticals

A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV341 in Young Healthy Male Subjects

First in man study with single and multiple rising doses with SLV341

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria healthy Exclusion Criteria not healthy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: SLV341
5 - 1000mg once daily
Placebo Comparator: B
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination.
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR
Time Frame: 1 - 28 days
1 - 28 days
Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring.
Time Frame: 28 days
28 days
Interaction with Midazolam
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Collaborators

Quintiles, Inc.

Investigators

  • Study Director: Ingrid Meuwsen, Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

January 30, 2009

First Submitted That Met QC Criteria

April 23, 2009

First Posted (Estimate)

April 24, 2009

Study Record Updates

Last Update Posted (Estimate)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 27, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S341.1.001
  • 2007-007196-17
  • 00887445

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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