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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42541

Enrollment

Registered

2015-11-25

Start date

2016-01-11

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

Infantile spasm West syndrome

Interventions

The study will consist of 1 period during which you will receive 30 mg radiprodil once. Radiprodil will be given as an oral suspension of 12 mL Should, in the opinion of the investigators, unaccept

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The purpose of the study is to investigate how quickly and to what extent radiprodil is absorbed and eliminated from the body (this is called pharmacokinetics).	—

Secondary

Measure	Time frame
Also 2 new blood sampling methods, allowing easier blood sampling in young children, will be tested	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)