Study to evaluate the pharmacokinetics of oxybate formulations in healthy subjects.

Study to evaluate the pharmacokinetics of oxybate formulations in healthy subjects. - JZP-258 PK Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43010

Enrollment

Registered

2016-06-14

Start date

2016-06-14

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

cataplexy narcolepsy

Interventions

Treatment A: 4.5 g JZP-258 taken with 60 mL water under fasting conditions, once Treatment B: 4.5 g Xyrem taken with 60 mL water under fasting conditions, once Treatment C: 4.5 g JZP-258 taken with 60

Oxybate formulations

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy male or female Caucasion volunteers 18-45 years, inclusive BMI 20-30 kg/m2, inclusive 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

Measure	Time frame
To assess the relative bioavailability and bioequivalence of JZP-258 oral solution versus Xyrem taken with 60 mL water under fasting conditions.	—

Secondary

Measure	Time frame
To assess the effect of food on pharmacokinetics (PK) of JZP-258 oral solution and Xyrem taken with 60 mL water To assess the safety and tolerability of JZP-258 oral solution and Xyrem administered under all dosing conditions in this study	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)