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Completed

NCT Number: NCT03764449

A Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers

This study was a non-randomized, open-label, parallel group, two-treatment study in healthy volunteers to investigate the absolute oral bioavailability of balovaptan. The study was conducted at 1 site in the Netherlands.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pra International Group B.V

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female subjects. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, urinalysis, and serology.
  • Body Mass Index of 18 to 30 kg/m2, inclusive.
  • For women of childbearing potential: agreement to use at least 2 acceptable contraceptive methods during the treatment period and for 90 days after the last dose of study drug.
  • For men: agreement to use contraceptive measures, and agreement to refrain from donating sperm until 90 days after the last dose of study drug.

Exclusion criteria

  • Female subjects who are pregnant or lactating.
  • Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.

Treatment and study plan

Oral Balovaptan

Drug

In Period 1, balovaptan was administered as a single oral dose.

In Period 2, balovaptan was administered as an oral dose once daily on Day 1 to Day 14.

IV Balovaptan

Drug

In Period 1, IV infusion of balovaptan was administered after the balovaptan oral dose.

In Period 2, IV infusion of balovaptan was administered after the final oral dose of balovaptan.

Primary outcomes

  1. Absolute Bioavailability of Oral Balovaptan at Dose Level A (Cohort 1)

    Time frame: Day 1 of Period 1 (Period 1 is 14 days).

    Absolute oral bioavailability of a single dose A of balovaptan.

Secondary outcomes

  1. Absolute Bioavailability of Oral Balovaptan at Dose Level B (Cohort 2)

    Time frame: Day 1 of Period 1 (Period 1 is 14 days).

    Absolute oral bioavailability of a single dose B balovaptan.

  2. Absolute Bioavailability of Oral Balovaptan at Dose A and Dose B

    Time frame: Day 14 of Period 2 (Period 2 is 19 days).

    Absolute oral bioavailability of balovaptan after once daily doses of Dose A and Dose B for 14 days.

  3. Maximum Plasma Concentration (Cmax) of IV Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  4. Cmax of Oral Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  5. Cmax of M2 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  6. Cmax of M3 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  7. Time to Maximum Observed Plasma Concentration (Tmax) of IV Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  8. Tmax of Oral Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  9. Tmax of M2 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  10. Tmax of M3 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  11. Apparent Terminal Half-Life (t1/2) of IV Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  12. T1/2 of Oral Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  13. T1/2 of M2 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  14. T1/2 of M3 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  15. Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measurable Plasma Concentration Time Point (AUC0-last) of IV Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days)

  16. AUC0-last of Oral Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days)

  17. AUC0-last of M2 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days)

  18. AUC0-last of M3 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days)

  19. Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of IV Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  20. AUC0-inf of Oral Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days).

  21. AUC0-inf of M2 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days).

  22. AUC0-inf of M3 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days).

  23. Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUC0-24) of IV Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  24. AUC0-24 of Oral Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  25. AUC0-24 of M2 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  26. AUC0-24 of M3 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  27. Last Measurable Plasma Concentration (Clast) of IV Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  28. Clast of Oral Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  29. Clast of M2 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  30. Clast of M3 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  31. Time of Last Measurable Plasma Concentration (Tlast) of IV Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  32. Tlast of Oral Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  33. Tlast of M2 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  34. Tlast of M3 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  35. Terminal Elimination Rate Constant (λz) of IV Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  36. λz of Oral Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  37. λz of M2 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  38. λz of M3 Metabolites

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  39. Total Body Clearance (CL) of IV Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  40. Volume of Distribution (Vss) of IV Balovaptan

    Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  41. Percentage of Participants With Treatment-Emergent Adverse Events

    Time frame: Up to 35 days from screening (sceening is up to 28 days prior to admission to the clinical research unit).

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single-Center, Non-Randomized, Open-Label, Parallel Group, Two-Treatment Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2018
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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