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Completed

NCT Number: NCT03586726

A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers

This study was a single-center, non-randomized, open-label, one-sequence, two-period, within-subject study to investigate the effects of multiple doses of rifampicin on the PK and safety of multiple doses of balovaptan in healthy subjects. 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.

Rifampicin-related Exclusion Criteria:

  • Subjects diagnosed, or suspected of having porphyria, and subjects with first-degree relatives diagnosed, or suspected of having porphyria.
  • Known hypersensitivity to rifampicin

Treatment and study plan

Balovaptan

Drug

In Period 1, balovaptan was administered alone as a once daily (qd) dose on Days 1 to 10.

In Period 2, balovaptan was administered as a qd dose on Days 7 to 16.

rifampicin

Drug

In Period 2, 600 mg of rifampicin will be administered alone as a qd dose from Day 1 to Day 6, and as a qd dose on Days 7 to 16.

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) for Balovaptan

    Time frame: Day 10 of Period 1 and Day 16 of Period 2

    Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.

  2. Maximum Plasma Concentration (Cmax) for M2 Metabolite

    Time frame: Day 10 of Period 1 and Day 16 of Period 2

    Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.

  3. Maximum Plasma Concentration (Cmax) for M3 Metabolite

    Time frame: Day 10 of Period 1 and Day 16 of Period 2

    Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.

  4. Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC0-24) for Balovaptan

    Time frame: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2

    AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.

  5. Area Under the Plasma Concentration Curve From Time 0 to 24 Hours for M2 Metabolite

    Time frame: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2

    AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.

  6. Area Under the Plasma Concentration Curve From Time 0 to 24 Hours for M3 Metabolite

    Time frame: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2

    AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.

Secondary outcomes

  1. Percentage of Participants With Adverse Events

    Time frame: Up to 21 days postdose

  2. Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan

    Time frame: Day 10 of Period 1 and Day 16 of Period 2

    Tmax is the first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units.

  3. Time to Maximum Observed Plasma Concentration for M2 Metabolite

    Time frame: Day 10 of Period 1 and Day 16 of Period 2

    Tmax is the first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units.

  4. Time to Maximum Observed Plasma Concentration for M3 Metabolite

    Time frame: Day 10 of Period 1 and Day 16 of Period 2

    Tmax is the first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units.

  5. Metabolite to Parent Ratio for M2 Metabolite Based on AUC0-24

    Time frame: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2

  6. Metabolite to Parent Ratio for M2 Metabolite Based on Cmax

    Time frame: Day 10 of Period 1 and Day 16 of Period 2

  7. Metabolite to Parent Ratio for M3 Metabolite Based on AUC0-24

    Time frame: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2

  8. Metabolite to Parent Ratio for M3 Metabolite Based on Cmax

    Time frame: Day 10 of Period 1 and Day 16 of Period 2

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single-Center, Non-Randomized, Open-Label, One-Sequence, Two-Period Within-Subject Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of Multiple Doses of Balovaptin In Healthy Volunteers

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 16, 2018
Registry last updated
Nov 7, 2019

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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