14-C ADME (Absorption, Disposition, Metabolism and Excretion) Study in Man
Phase 1
Completed
- Conditions
- Healthy Subjects
- Interventions
- Drug: SLV337 capsuleDrug: SLV337 suspension
- Registration Number
- NCT01176201
- Lead Sponsor
- Abbott Products
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description B SLV337 capsule 5 x 200 mg immediate release capsule A SLV337 suspension 400 mg suspension
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Site Reference ID/Investigator# 61345
🇳🇱Zuidlaren, Netherlands