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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01044524

Enrollment

Registered

2010-01-08

Start date

2010-02-28

Completion date

2010-03-31

Last updated

2010-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacology, Clinical

Keywords

14C labeled ADME (Aborption Distribution Metabolism and Elimination) study, Phase I

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.

Interventions

RADIATIONSLV 334

2000 mg via i.v. solution

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

healthy non-smoking subjects

Exclusion criteria

QTc \> 430 ms; positive drug screen

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Laboratory safety variables	16 days
adverse events	16 days
Physical examination	16 days
vital signs	16 days
ECG	16 days

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026