A double-blind, placebo controlled, randomised, parallel group study with an open-label cross-over part, investigating safety, tolerability, pharmacokinetics, and pharmacodynamics after single ascending oral doses and a single intravenous dose of the vasopressin V2-receptor agonist FE 201836

Completed

• Conditions: octuria; night voiding

• Registration Number: NL-OMON43629
• Lead Sponsor: Ferring

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 76

Inclusion Criteria

- healthy male or female
- 18-45 years old inclusive
- BMI between 18.5 - 29.9 kg/m2
- non smoker

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90
days before the start of this study or being a blood donor within 60 days from the start of the study. In case of
donating more than 1.5 liters of blood in the 10 months prior the start of this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To assess the safety and tolerability of single intravenous and oral doses of<br /><br>FE 201836<br /><br>- To determine single oral dose pharmacokinetics of FE 201836<br /><br>- To determine single intravenous dose pharmacokinetics of FE 201836<br /><br>- To determine single intravenous dose pharmacodynamics of FE 201836<br /><br>- To study the metabolite pattern of FE 201836 in plasma and urine<br /><br>- To collect data for analysis of the effect of FE 201836 on the QT interval<br /><br>- To compare intravenous single dose pharmacokinetics and pharmacodynamics of<br /><br>FE 201836 with desmopressin</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>