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

Solvay

Status and phase: Completed; Phase 1

Conditions: Pharmacology, Clinical

Treatments: Radiation: SLV 334

Study type: Interventional

Funder types: Industry

Identifiers

NCT01044524

S334.1.004

01044524 (Other Grant/Funding Number)

2009-017406-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

1

Experimental group

Description:

SLV 334

Treatment:

Radiation: SLV 334