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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586726
• Other study ID #: WP40608
• Secondary ID: 2018-001783-40
• Status: Completed
• Phase: Phase 1
• Start date: July 24, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: October 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 15, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Balovaptan
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
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.

Locations

Country	Name	City	State
Netherlands	Pra International Group B.V	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax) for Balovaptan	Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.	Day 10 of Period 1 and Day 16 of Period 2
Primary	Maximum Plasma Concentration (Cmax) for M2 Metabolite	Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.	Day 10 of Period 1 and Day 16 of Period 2
Primary	Maximum Plasma Concentration (Cmax) for M3 Metabolite	Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.	Day 10 of Period 1 and Day 16 of Period 2
Primary	Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC0-24) for Balovaptan	AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.	Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
Primary	Area Under the Plasma Concentration Curve From Time 0 to 24 Hours for M2 Metabolite	AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.	Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
Primary	Area Under the Plasma Concentration Curve From Time 0 to 24 Hours for M3 Metabolite	AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.	Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
Secondary	Percentage of Participants With Adverse Events		Up to 21 days postdose
Secondary	Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan	Tmax is the first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units.	Day 10 of Period 1 and Day 16 of Period 2
Secondary	Time to Maximum Observed Plasma Concentration for M2 Metabolite	Tmax is the first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units.	Day 10 of Period 1 and Day 16 of Period 2
Secondary	Time to Maximum Observed Plasma Concentration for M3 Metabolite	Tmax is the first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units.	Day 10 of Period 1 and Day 16 of Period 2
Secondary	Metabolite to Parent Ratio for M2 Metabolite Based on AUC0-24		Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
Secondary	Metabolite to Parent Ratio for M2 Metabolite Based on Cmax		Day 10 of Period 1 and Day 16 of Period 2
Secondary	Metabolite to Parent Ratio for M3 Metabolite Based on AUC0-24		Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
Secondary	Metabolite to Parent Ratio for M3 Metabolite Based on Cmax		Day 10 of Period 1 and Day 16 of Period 2