14-C ADME (Absorption, Disposition, Metabolism and Excretion) Study in Man

An Open-Label Study to Determine ADME of 14C Labeled SLV337 After a Single Dose of an Oral Suspension

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01176201

Enrollment

Registered

2010-08-05

Start date

2010-07-31

Completion date

2010-10-31

Last updated

2011-08-26

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

Conditions

Healthy Subjects

Keywords

SLV337, Diabetes, Relative bioavailability, ADME

Brief summary

This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.

Detailed description

The Absorption, Disposition, Metabolism and Excretion of SLV337 will be investigated after a single dose of an oral suspension of 14C-SLV337.

Interventions

DRUGSLV337 suspension

400 mg experimental

DRUGSLV337 capsule

5 x 200 mg immediate release capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI 18 - 28 kg/m2 * SBP 90-140 * DBP 50-90

Exclusion criteria

* Seizures, * Orthostatic hypotension

Design outcomes

Primary

Measure	Time frame
AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 (Part 1 and Part 2)	Part 1: 5 days Part 2: 8 days
AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 acyl-glucoronide (Part 2)	Part 2: 8 days
Excretion balance of total 14C-radioactivity (Part 2)	Part 2: 8 days
Total 14C-radioactivity (Part 2)	Part 2: 8 days
Metabolic profiling and identification of 14C-labeled parent compound and metabolites of SLV337 in plasma, urine and feces (Part 2)	Part 2: 8 days

Secondary

Measure	Time frame
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part 1 and Part 2)	Part 1: 19 days Part 2: 15 days

Countries

Netherlands

Outcome results

None listed

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