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.
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
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.
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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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