Healthy VolunteersPhase 1NCT03586726

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

A Phase 1 study testing Balovaptan and Rifampicin in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Balovaptan and Rifampicin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteNetherlands
Study dates: 24 Jul 2018to 15 Nov 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Pra International Group B.V
Groningen, 9728 NZ

Other trials in Netherlands

About this study

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

Conditions: Healthy Volunteers
Being tested: Balovaptan, Rifampicin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BalovaptanDrug
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.
RifampicinDrug
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.

Study groups in NCT03586726
Study group	Role	What they receive
Balovaptan + Rifampicin	Experimental	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. Receives: Drug: Balovaptan; Drug: Rifampicin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 10 of Period 1 and Day 16 of Period 2
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.
Measured: Day 10 of Period 1 and Day 16 of Period 2
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.
Measured: Day 10 of Period 1 and Day 16 of Period 2
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.
Measured: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
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.
Measured: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
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.
Measured: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2

Secondary outcomes (8)

Percentage of Participants With Adverse Events
Measured: Up to 21 days postdose
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.
Measured: Day 10 of Period 1 and Day 16 of Period 2
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.
Measured: Day 10 of Period 1 and Day 16 of Period 2
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.
Measured: Day 10 of Period 1 and Day 16 of Period 2
Metabolite to Parent Ratio for M2 Metabolite Based on AUC0-24
Measured: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
Metabolite to Parent Ratio for M2 Metabolite Based on Cmax
Measured: Day 10 of Period 1 and Day 16 of Period 2
Metabolite to Parent Ratio for M3 Metabolite Based on AUC0-24
Measured: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
Metabolite to Parent Ratio for M3 Metabolite Based on Cmax
Measured: Day 10 of Period 1 and Day 16 of Period 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jul 201815 Nov 2018

First posted16 Jul 2018
Study start24 Jul 2018
Primary completion2 Nov 2018
Study completion15 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03586726
Sponsor's protocol ID: WP40608
Other IDs: 2018-001783-40, 2018
Status last verified: Oct 2019
First submitted: 3 Jul 2018
Last updated: 7 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Derks MGM, Wandel C, Young A, Bolt SK, Meyenberg C. Open-Label Assessment of the Effects of Itraconazole and Rifampicin on Balovaptan Pharmacokinetics in Healthy Volunteers. Adv Ther. 2020 Nov;37(11):4720-4729. doi: 10.1007/s12325-020-01491-y. Epub 2020 Sep 15.
PubMed 32935287

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03586726
Acronym / sponsor ID: WP40608
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 24 Jul 2018 (actual)
Primary completion: 2 Nov 2018 (actual)
Study completion: 15 Nov 2018 (actual)
First posted: 16 Jul 2018 (actual)
Results: Posted 7 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Balovaptan + Rifampicin	Experimental	Drug: Balovaptan, Drug: RifampicinParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.
Subjects diagnosed, or suspected of having porphyria, and subjects with first-degree relatives diagnosed, or suspected of having porphyria.
Known hypersensitivity to rifampicin

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BalovaptanIn 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.	Drug	Balovaptan + Rifampicin
RifampicinIn 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.	Drug	Balovaptan + Rifampicin

Primary outcome

Maximum Plasma Concentration (Cmax) for Balovaptan
Time frame: 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.
Maximum Plasma Concentration (Cmax) for M2 Metabolite
Time frame: 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.
Maximum Plasma Concentration (Cmax) for M3 Metabolite
Time frame: 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
Time frame: 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.
Area Under the Plasma Concentration Curve From Time 0 to 24 Hours for M2 Metabolite
Time frame: 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.
Area Under the Plasma Concentration Curve From Time 0 to 24 Hours for M3 Metabolite
Time frame: 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.

8 secondary outcomes

Percentage of Participants With Adverse Events
Time frame: Up to 21 days postdose
Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan
Time frame: Day 10 of Period 1 and Day 16 of Period 2
Time to Maximum Observed Plasma Concentration for M2 Metabolite
Time frame: Day 10 of Period 1 and Day 16 of Period 2
Time to Maximum Observed Plasma Concentration for M3 Metabolite
Time frame: Day 10 of Period 1 and Day 16 of Period 2
Metabolite to Parent Ratio for M2 Metabolite Based on AUC0-24
Time frame: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
Metabolite to Parent Ratio for M2 Metabolite Based on Cmax
Time frame: Day 10 of Period 1 and Day 16 of Period 2
Metabolite to Parent Ratio for M3 Metabolite Based on AUC0-24
Time frame: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
Metabolite to Parent Ratio for M3 Metabolite Based on Cmax
Time frame: Day 10 of Period 1 and Day 16 of Period 2

Results and safety

Results posted to the registry on 7 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Balovaptan + Rifampicin	16	15

Primary outcome: Maximum Plasma Concentration (Cmax) for Balovaptan

Time frame: Day 10 of Period 1 and Day 16 of Period 2. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Balovaptan + Rifampicin n = 16
Balovaptan (Period 1)	94.2 (33.4)
Balovaptan + rifampicin (Period 2)	12.9 (22.8)

Population analysed: The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.

Primary outcome: Maximum Plasma Concentration (Cmax) for M2 Metabolite

Time frame: Day 10 of Period 1 and Day 16 of Period 2. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Balovaptan + Rifampicin n = 16
Balovaptan (Period 1)	22.0 (22.7)
Balovaptan + rifampicin (Period 2)	8.09 (20.5)

Primary outcome: Maximum Plasma Concentration (Cmax) for M3 Metabolite

Time frame: Day 10 of Period 1 and Day 16 of Period 2. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Balovaptan + Rifampicin n = 16
Balovaptan (Period 1)	49.6 (26.4)
Balovaptan + rifampicin (Period 2)	10.9 (23.2)

Primary outcome: Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC0-24) for Balovaptan

Time frame: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2. Geometric mean (Geometric Coefficient of Variation). Unit: ng.h/mL

Measure	Balovaptan + Rifampicin n = 16
Balovaptan (Period 1)	1000 (29.6)
Balovaptan + rifampicin (Period 2)	67.0 (16.3)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 21 days postdose (15 November 2018).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BALOVAPTAN+RIFAMPICIN	0 of 16 (0%)	15 of 16 (93.8%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32935287Derks MGM, Wandel C, Young A, Bolt SK, Meyenberg C. Open-Label Assessment of the Effects of Itraconazole and Rifampicin on Balovaptan Pharmacokinetics in Healthy Volunteers. Adv Ther. 2020 Nov;37(11):4720-4729. doi: 10.1007/s12325-020-01491-y. Epub 2020 Sep 15.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Balovaptan and Rifampicin in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) for Balovaptan (time frame: Day 10 of Period 1 and Day 16 of Period 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03586726, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.