An open label, sequential study to assess the drug-drug interaction of Divalproex Sodium extended release (ER) at steady-state on FT218 formulation administered at a single 6 g dose in healthy volunteeers

An open label, sequential study to assess the drug-drug interaction of Divalproex Sodium extended release (ER) at steady-state on FT218 formulation administered at a single 6 g dose in healthy volunteeers - FT218 Divalproex Sodium Drug-Drug Interaction Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46476

Enrollment

Registered

2018-02-27

Start date

2018-03-09

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Cataplexy Narcolepsy

Interventions

Not applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18-55 years, inclusive BMI 18.0-28.0 kg/m2, inclusive Weight >= 60 kg

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 pharmacokinetics (PK) of a single 6 g dose of FT218 with or without 1250 mg/day divalproex sodium ER at steady-state in healthy volunteers.	—

Secondary

Measure	Time frame
To assess the safety of a single dose of 6 g FT218 with or without 1250 mg/day divalproex sodium ER at steady-state in healthy volunteers	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)