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OpenTrials
Completed

NCT Number: NCT01044524

Study to Investigate ADME of 14C Labeled SLV334 After an i.v. Infusion

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.

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Key information

Conditions

Pharmacology, Clinical

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

S334.1.004 - Site 1

Zuidlaren, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy non-smoking subjects Exclusion Criteria QTc > 430 ms; positive drug screen

Treatment and study plan

SLV 334

Radiation

2000 mg via i.v. solution

Primary outcomes

  1. Percentage excreted in urine and feces

    Time frame: 16 days

  2. metabolic profile SLV334

    Time frame: 16 days

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

    Time frame: 16 Days

Secondary outcomes

  1. adverse events

    Time frame: 16 days

  2. vital signs

    Time frame: 16 days

  3. ECG

    Time frame: 16 days

  4. Laboratory safety variables

    Time frame: 16 days

  5. Physical examination

    Time frame: 16 days

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study title

An Open Label Study to Determine ADME of 14C Labeled SLV334 and Its Metabolites After Single Intravenous Dose Infusion

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 8, 2010
Registry last updated
Sep 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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