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 202217

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 202217 - FE 202217 SAD and cross-over study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42319

Enrollment

Registered

2015-06-18

Start date

2015-06-23

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

nocturia night voiding

Interventions

Part 1: during this research the volunteer will receive FE 202217 or placebo as a 20 ml oral solution following a night of fasting. Part 2: in period one and 3 the volunteer will receive the study

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
- To assess the safety and tolerability of single intravenous and oral doses of FE 202217 - To determine single oral dose pharmacokinetics of FE 202217 - To determine single intravenous dose pharmacokinetics of FE 202217 - To determine single intravenous dose pharmacodynamics of FE 202217 - To study the metabolite pattern of FE 202217 in plasma and urine - To collect data for analysis of the effect of FE 202217 on the QT interval - To compare intravenous single dose pharmacokinetics and pharmacodynamics of FE 202217 with desmopressin	—

Measure

Time frame

- To assess the safety and tolerability of single intravenous and oral doses of FE 202217 - To determine single oral dose pharmacokinetics of FE 202217 - To determine single intravenous dose pharmacokinetics of FE 202217 - To determine single intravenous dose pharmacodynamics of FE 202217 - To study the metabolite pattern of FE 202217 in plasma and urine - To collect data for analysis of the effect of FE 202217 on the QT interval - To compare intravenous single dose pharmacokinetics and pharmacodynamics of FE 202217 with desmopressin

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)