A single-center, open-label, single oral dose study to investigate the absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetics of EMA401 after a single dose of [14C]EMA401 in healthy male subjects

Completed

• Conditions: neuralgia; peripheral neuropathic pain; 10034606

• Registration Number: NL-OMON44485
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

- healthy male subjects
- 40-55 yrs, inclusive
- BMI: 18.0-30.0 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study. Donation or loss of 50 mL or more of blood within eight weeks prior to initial dosing, or longer if required by local regulation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Excretion/ mass balance of [14C]-radioactivity in excreta (urine, feces) as<br /><br>percentage (% ) of administered dose<br /><br>- Cmax, Tmax, AUC, T1/2 and any other PK parameters as appropriate from the<br /><br>concentration vs. time data of 14C radioactivity (whole blood, plasma)<br /><br>- Cmax, Tmax, T1/2, AUC, CL/F, Vz/F any other pharmacokinetic parameter as<br /><br>appropriate from concentration vs. time profiles of EMA401 and known<br /><br>metabolites, if applicable.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>All safety and tolerability data (including vital signs, ECG parameters,<br /><br>clinical safety laboratory parameters, averse events reporting, physical<br /><br>examination) up until and including 14 days post-dose</p><br>