An open-label, randomized crossover pilot study to evaluate the pharmacokinetics, bioavailability, and bioequivalence following administration of Oxybate formulations in healthy subjects.

An open-label, randomized crossover pilot study to evaluate the pharmacokinetics, bioavailability, and bioequivalence following administration of Oxybate formulations in healthy subjects. - KEY-507 PK, BA and BE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43111

Enrollment

Registered

2016-04-26

Start date

2016-05-18

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

narcolepsy sleeping disorder

Interventions

Treatment A: 1 x 9 mL KEY-507-A Treatment B: 1 x 9 mL KEY-507-G Treatment C: 1 x 9 mL KEY-507-C Treatment D: 1 x 9 mL KEY-507-D Treatment E: 1 x 9 mL Xyrem

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female volunteers 18 - 45 years of age, inclusive BMI 20 - 30 kg/m2, inclusive minimum bodyweight 60 kg 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 the four KEY-507 oral solutions compared with Xyrem under fasting conditions.	—

Secondary

Measure	Time frame
To assess the safety and tolerability of the four KEY-507 oral solutions and Xyrem under fasting conditions To assess the palatability of the taste of the four KEY-507 oral solutions and Xyrem under fasting conditions	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)