Healthy VolunteersPhase 1NCT03579719
A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers
A Phase 1 study testing Balovaptan and Itraconazole in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in Netherlands.
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. 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 Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jul 2018to 9 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- Balovaptan, Itraconazole
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 orally once daily (qd) on Days 1 to 10.
In Period 2, balovaptan was administered qd on Days 6 to 20.
ItraconazoleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Balovaptan + Itraconzole | Experimental | 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. Receives: Drug: Balovaptan; Drug: Itraconazole |
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, Day 10 and Day 15 of Period 2
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.
Measured: Day 10 of Period 1, Day 10 and Day 15 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, Day 10 and Day 15 of Period 2
Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for Balovaptan
Measured: 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)
Measured: 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 M3 Metabolite
Measured: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan
Measured: 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)
Measured: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for M3 Metabolite
Measured: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Secondary outcomes (5)
Trough Plasma Concentration (Ctrough) for Balovaptan
Measured: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Trough Plasma Concentration (Ctrough) for M2 Metabolite (as Applicable)
Measured: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Trough Plasma Concentration (Ctrough) for M3 Metabolite
Measured: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Time to Steady State for Balovaptan
Measured: 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
Measured: Up to 21 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start10 Jul 2018
- Primary completion9 Nov 2018
- Study completion9 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579719
- Sponsor's protocol ID
- WP40609
- Other IDs
- 2018-001454-10, 2018
- Status last verified
- Oct 2019
- First submitted
- 26 Jun 2018
- Last updated
- 4 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
Study at a glance
From the registry record, last updated by the sponsor on 4 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 Itraconazole on the Pharmacokinetics of Multiple Doses of Balovaptan in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03579719
- Acronym / sponsor ID
- WP40609
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balovaptan + Itraconzole | Experimental | Drug: Balovaptan, Drug: ItraconazoleDosing 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. |
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 (2 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.
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 orally once daily (qd) on Days 1 to 10. In Period 2, balovaptan was administered qd on Days 6 to 20. | Drug | Balovaptan + Itraconzole |
| ItraconazoleIn 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. | Drug | Balovaptan + Itraconzole |
Primary outcome
Maximum Plasma Concentration (Cmax) for Balovaptan
Time frame: 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)
Time frame: 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 M3 Metabolite
Time frame: 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
Time frame: 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)
Time frame: 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 M3 Metabolite
Time frame: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan
Time frame: 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)
Time frame: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for M3 Metabolite
Time frame: Day 10 of Period 1; Day 10 and Day 15 of Period 2
5 secondary outcomes
Trough Plasma Concentration (Ctrough) for Balovaptan
Time frame: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Trough Plasma Concentration (Ctrough) for M2 Metabolite (as Applicable)
Time frame: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Trough Plasma Concentration (Ctrough) for M3 Metabolite
Time frame: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Time to Steady State for Balovaptan
Time frame: 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
Time frame: Up to 21 days postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 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 Itraconazole 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 2 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 4 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 4 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, Day 10 and Day 15 of Period 2). The study lists 9 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 NCT03579719, 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 4 Nov 2019.