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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579719
• Other study ID #: WP40609
• Secondary ID: 2018-001454-10
• Status: Completed
• Phase: Phase 1
• Start date: July 10, 2018
• Est. completion date: November 9, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Balovaptan
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
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.

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, Day 10 and Day 15 of Period 2
Primary	Maximum Plasma Concentration (Cmax) for M2 Metabolite (as Applicable)	Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.	Day 10 of Period 1, Day 10 and Day 15 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, Day 10 and Day 15 of Period 2
Primary	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
Primary	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
Primary	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
Primary	Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan		Day 10 of Period 1; Day 10 and Day 15 of Period 2
Primary	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
Primary	Time to Maximum Observed Plasma Concentration (Tmax) for M3 Metabolite		Day 10 of Period 1; Day 10 and Day 15 of Period 2
Secondary	Trough Plasma Concentration (Ctrough) for Balovaptan		Day 10 of Period 1; Day 10 and Day 15 of Period 2
Secondary	Trough Plasma Concentration (Ctrough) for M2 Metabolite (as Applicable)		Day 10 of Period 1; Day 10 and Day 15 of Period 2
Secondary	Trough Plasma Concentration (Ctrough) for M3 Metabolite		Day 10 of Period 1; Day 10 and Day 15 of Period 2
Secondary	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
Secondary	Percentage of Participants With Adverse Events		Up to 21 days postdose