A SINGLE ORAL DOSE STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETIC PROFILE OF RADIPRODIL IN ADULT HEALTHY VOLUNTEERS

Completed

• Conditions: Infantile spasm; West syndrome; 10028037

• Registration Number: NL-OMON42541
• Lead Sponsor: PRA Health Sciences

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: 10

Inclusion Criteria

Healthy male and female subjects
18-45 years, inclusive
BMI:18 to 30kg/m² (inclusive)

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study or in case of donating more than 1.5 liter 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>The purpose of the study is to investigate how quickly and to what extent<br /><br>radiprodil is absorbed and eliminated from the body (this is called<br /><br>pharmacokinetics).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Also 2 new blood sampling methods, allowing easier blood sampling in young<br /><br>children, will be tested</p><br>