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AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, TWO-TREATMENT (FED VS FASTING), TWO-PERIOD, TWO-SEQUENCE CROSSOVER STUDY TO ASSESS THE EFFECT OF FOOD ON SODIUM OXYBATE FOR EXTENDED RELEASE ORAL SUPENSION (FT218) FORMULATION ADMINISTRERED AT 6 G IN HEALTHY VOLUNTEERS

AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, TWO-TREATMENT (FED VS FASTING), TWO-PERIOD, TWO-SEQUENCE CROSSOVER STUDY TO ASSESS THE EFFECT OF FOOD ON SODIUM OXYBATE FOR EXTENDED RELEASE ORAL SUPENSION (FT218) FORMULATION ADMINISTRERED AT 6 G IN HEALTHY VOLUNTEERS - FT218 PK, FE Study in Healthy Subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44554
Enrollment
16
Registered
2017-10-17
Start date
2017-11-09
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 and narcolepsy

Interventions

Not applicable.

Sponsors

Flamel Ireland Limited (Ltd) trading under the business name Avadel Ireland
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female age 18 - 55 years, inclusive BMI 18.0 - 28.0 kilograms/meter2, inclusive weight 60.0 kg or more. non smoking

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

MeasureTime frame
To assess the pharmacokinetics (PK) and of a single dose of 6 g FT218 taken 30 minutes after the start of a standardized meal (fed condition) vs. 6 g FT218 taken after a 10-hour overnight fast (fasted condition) in healthy volunteers.—

Secondary

MeasureTime frame
To assess the safety of a single dosing of 6 g FT218 in fasted and fed states in healthy volunteers.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)