A SINGLE DOSE, RANDOMIZED, OPEN-LABEL, 4-WAY CROSSOVER STUDY TO ASSESS THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ESKETAMINE (ORAL TABLET OF 20 MG AND 100 MG, ORAL SOLUTION OF 20 MG AND IV INFUSION OF 20 MG) IN HEALTHY VOLUNTEERS.

A SINGLE DOSE, RANDOMIZED, OPEN-LABEL, 4-WAY CROSSOVER STUDY TO ASSESS THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ESKETAMINE (ORAL TABLET OF 20 MG AND 100 MG, ORAL SOLUTION OF 20 MG AND IV INFUSION OF 20 MG) IN HEALTHY VOLUNTEERS. - Esketamine safety and pharmacokinetics study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43097

Enrollment

Registered

2016-09-21

Start date

2016-09-22

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

Depression.

Interventions

20 mg esketamine as intravenous infusion (prepared with Ketanest-S®, 5 mg per mL)

Depression

Esketamine

TEV-50370

Period 1, 2, 3 or 4, Day 1

20 mg esketamine as oral tablet (TEV-50370) Period 1, 2, 3 or 4, Day 1

100 mg esketamine as oral tablet (TEV-50370) Period 1, 2, 3 or 4, Day 1

20 mg esketamine as oral solution (prepared with Ketanest-S®, 5 mg per mL) Period 1, 2, 3 or 4, Day 1

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male or female 18-55 years, inclusive BMI 19.0 - 29.0 kg/m2, inclusive at least 60 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

Measure	Time frame
* To evaluate the safety and tolerability after oral and intravenous (iv) administration of esketamine * To evaluate the pharmacokinetics (PK) of esketamine and its metabolites after oral and iv administration of esketamine * To assess the absolute bioavailability of esketamine after oral administration of esketamine * To assess the relative bioavailability of oral tablets with esketamine compared with an oral solution with esketamine * To assess the dose proportionality of esketamine and its metabolites after oral administration of 20 mg and 100 mg esketamine as oral tablets * To assess the parent to metabolite ratios after oral and iv administration of esketamine	—

Measure

Time frame

* To evaluate the safety and tolerability after oral and intravenous (iv) administration of esketamine * To evaluate the pharmacokinetics (PK) of esketamine and its metabolites after oral and iv administration of esketamine * To assess the absolute bioavailability of esketamine after oral administration of esketamine * To assess the relative bioavailability of oral tablets with esketamine compared with an oral solution with esketamine * To assess the dose proportionality of esketamine and its metabolites after oral administration of 20 mg and 100 mg esketamine as oral tablets * To assess the parent to metabolite ratios after oral and iv administration of esketamine

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)