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

Phase 1

Completed

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

• Registration Number: NCT03579719
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-09
• Study Start: 2018-07-10
• Primary Completion: 2018-11-09
• Study Completion: 2018-11-09
• Status Verified: 2019-10
• Results First Submitted: 2019-10-14
• Results First Submitted QC: 2019-10-14
• Last Update Submitted: 2019-10-14
• Results First Posted: 2019-11-04
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Balovaptan + Itraconzole	Balovaptan	Dosing in Period 1 was separated by at least a 7 day washout period before dosing starts in Period 2. Participants received the study drugs in 2 periods over a total of 37 days.
Balovaptan + Itraconzole	Itraconazole	Dosing in Period 1 was separated by at least a 7 day washout period before dosing starts in Period 2. Participants received the study drugs in 2 periods over a total of 37 days.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) for M3 Metabolite	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.
Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for Balovaptan	Day 10 of Period 1, Day 10 and Day 15 of Period 2
Maximum Plasma Concentration (Cmax) for Balovaptan	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.
Maximum Plasma Concentration (Cmax) for M2 Metabolite (as Applicable)	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.
Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for M3 Metabolite	Day 10 of Period 1, Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for M3 Metabolite	Day 10 of Period 1; Day 10 and Day 15 of Period 2
Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for M2 Metabolite (as Applicable)	Day 10 of Period 1, Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan	Day 10 of Period 1; Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for M2 Metabolite (as Applicable)	Day 10 of Period 1; Day 10 and Day 15 of Period 2

Secondary Outcome Measures

Name	Time	Method
Trough Plasma Concentration (Ctrough) for M2 Metabolite (as Applicable)	Day 10 of Period 1; Day 10 and Day 15 of Period 2
Time to Steady State for Balovaptan	Days 1, 3, 5, 8, 9, 10 in Period 1 and Days 1, 3, 5, 8, 9, 10, 13, 14, 15 in Period 2
Percentage of Participants With Adverse Events	Up to 21 days postdose
Trough Plasma Concentration (Ctrough) for Balovaptan	Day 10 of Period 1; Day 10 and Day 15 of Period 2
Trough Plasma Concentration (Ctrough) for M3 Metabolite	Day 10 of Period 1; Day 10 and Day 15 of Period 2

Trial Locations

Locations (1)

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