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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Balovaptan; Drug: Rifampicin

• Registration Number: NCT03586726
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-16
• Study Start: 2018-07-24
• Primary Completion: 2018-11-02
• Study Completion: 2018-11-15
• Status Verified: 2019-10
• Results First Submitted: 2019-10-15
• Results First Submitted QC: 2019-10-15
• Last Update Submitted: 2019-10-15
• Results First Posted: 2019-11-07
• Last Update Posted: 2019-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Balovaptan + Rifampicin	Balovaptan	Participants received the study drugs in 2 periods. There was a minimum of a 14-day to a maximum of a 21-day washout between the last dose in Period 1 and the first dose in Period 2.
Balovaptan + Rifampicin	Rifampicin	Participants received the study drugs in 2 periods. There was a minimum of a 14-day to a maximum of a 21-day washout between the last dose in Period 1 and the first dose in Period 2.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) for M3 Metabolite	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.
Area Under the Plasma Concentration Curve From Time 0 to 24 Hours for M2 Metabolite	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.
Maximum Plasma Concentration (Cmax) for M2 Metabolite	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.
Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC0-24) for Balovaptan	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.
Maximum Plasma Concentration (Cmax) for Balovaptan	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.
Area Under the Plasma Concentration Curve From Time 0 to 24 Hours for M3 Metabolite	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 Outcome Measures

Name	Time	Method
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
Percentage of Participants With Adverse Events	Up to 21 days postdose
Time to Maximum Observed Plasma Concentration for M2 Metabolite	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.
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
Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan	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.
Metabolite to Parent Ratio for M2 Metabolite Based on Cmax	Day 10 of Period 1 and Day 16 of Period 2
Time to Maximum Observed Plasma Concentration for M3 Metabolite	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.
Metabolite to Parent Ratio for M3 Metabolite Based on Cmax	Day 10 of Period 1 and Day 16 of Period 2

Trial Locations

Locations (1)

Pra International Group B.V; 🇳🇱 Groningen, Netherlands