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Completed

NCT Number: NCT03579719

A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers

This study was a non-randomized, open-label, one-sequence, two-period within-subject study to investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female volunteers using itraconazole as a CYP3A inhibitor. 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

Balovaptan

Drug

In Period 1, balovaptan was administered orally once daily (qd) on Days 1 to 10.

In Period 2, balovaptan was administered qd on Days 6 to 20.

Itraconazole

Drug

In Period 2, 200 mg itraconzole was administered bid for 4 days and qd on Days 5-20, approximately 12 hours apart. On Days 6-20, 200 mg itraconazole was administered qd.

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) for Balovaptan

    Time frame: Day 10 of Period 1, Day 10 and Day 15 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 (as Applicable)

    Time frame: Day 10 of Period 1, Day 10 and Day 15 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, Day 10 and Day 15 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 Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for Balovaptan

    Time frame: Day 10 of Period 1, Day 10 and Day 15 of Period 2

  5. Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for M2 Metabolite (as Applicable)

    Time frame: Day 10 of Period 1, Day 10 and Day 15 of Period 2

  6. Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for M3 Metabolite

    Time frame: Day 10 of Period 1, Day 10 and Day 15 of Period 2

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

    Time frame: Day 10 of Period 1; Day 10 and Day 15 of Period 2

  8. Time to Maximum Observed Plasma Concentration (Tmax) for M2 Metabolite (as Applicable)

    Time frame: Day 10 of Period 1; Day 10 and Day 15 of Period 2

  9. Time to Maximum Observed Plasma Concentration (Tmax) for M3 Metabolite

    Time frame: Day 10 of Period 1; Day 10 and Day 15 of Period 2

Secondary outcomes

  1. Trough Plasma Concentration (Ctrough) for Balovaptan

    Time frame: Day 10 of Period 1; Day 10 and Day 15 of Period 2

  2. Trough Plasma Concentration (Ctrough) for M2 Metabolite (as Applicable)

    Time frame: Day 10 of Period 1; Day 10 and Day 15 of Period 2

  3. Trough Plasma Concentration (Ctrough) for M3 Metabolite

    Time frame: Day 10 of Period 1; Day 10 and Day 15 of Period 2

  4. Time to Steady State for Balovaptan

    Time frame: Days 1, 3, 5, 8, 9, 10 in Period 1 and Days 1, 3, 5, 8, 9, 10, 13, 14, 15 in Period 2

  5. Percentage of Participants With Adverse Events

    Time frame: Up to 21 days postdose

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 Itraconazole on the Pharmacokinetics of Multiple Doses of Balovaptan in Healthy Volunteers

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 9, 2018
Registry last updated
Nov 4, 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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