Phase 1
Completed N=16
A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers
Healthy Volunteers
Source: ClinicalTrials.gov NCT03586726 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) for Balovaptan — 94.2; 12.9 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) for Balovaptan |
94.2; 12.9 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) for M2 Metabolite |
22.0; 8.09 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) for M3 Metabolite |
49.6; 10.9 | — |
| PRIMARY Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC0-24) for Balovaptan |
1000; 67.0 | — |
| PRIMARY Area Under the Plasma Concentration Curve From Time 0 to 24 Hours for M2 Metabolite |
448; 149 | — |
| PRIMARY Area Under the Plasma Concentration Curve From Time 0 to 24 Hours for M3 Metabolite |
844; 110 | — |
| SECONDARY Percentage of Participants With Adverse Events |
94 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan |
1.00; 1.00 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration for M2 Metabolite |
2.50; 3.00 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration for M3 Metabolite |
1.00; 1.00 | — |
| SECONDARY Metabolite to Parent Ratio for M2 Metabolite Based on AUC0-24 |
0.430; 2.14 | — |
| SECONDARY Metabolite to Parent Ratio for M2 Metabolite Based on Cmax |
0.225; 0.606 | — |
| SECONDARY Metabolite to Parent Ratio for M3 Metabolite Based on AUC0-24 |
0.872; 1.70 | — |
| SECONDARY Metabolite to Parent Ratio for M3 Metabolite Based on Cmax |
0.545; 0.873 | — |
Eligibility Criteria
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.
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
Data sourced from ClinicalTrials.gov (NCT03586726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.