NCT01044524

Brief Summary

This study will investigate the absorption, distribution, metabolism and excretion after giving 2000 mg 14C-SLV334 via a 1-hour infusion. The absolute bioavailability will also be determined.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2009

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 17, 2010

Status Verified

September 1, 2010

Enrollment Period

28 days

First QC Date

December 11, 2009

Last Update Submit

September 16, 2010

Conditions

Pharmacology, Clinical

Keywords

14C labeled ADME (Aborption Distribution Metabolism and Elimination) studyPhase I

Outcome Measures

Primary Outcomes (3)

  • Percentage excreted in urine and feces

    16 days

  • metabolic profile SLV334

    16 days

  • AUC, CL, lambda z, Cmax, t1/2, tmax and Vss

    16 Days

Secondary Outcomes (5)

  • adverse events

    16 days

  • vital signs

    16 days

  • ECG

    16 days

  • Laboratory safety variables

    16 days

  • Physical examination

    16 days

Study Arms (1)

1

EXPERIMENTAL

SLV 334

Radiation: SLV 334

Interventions

SLV 334RADIATION

2000 mg via i.v. solution

1

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S334.1.004 - Site 1

Zuidlaren, Netherlands

Location

Study Officials

  • Anita Vanderlaan

    Abbott Products

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 11, 2009

First Posted

January 8, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 17, 2010

Record last verified: 2010-09

Locations

NL(1)