Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Balovaptan · 5 trials · 3 indications
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. Measured 3 times over 12 weeks.
Maximum plasma concentration of Balovaptan is estimated using non-compartmental methods. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units
Area under the plasma concentration-time curve (time 0 to infinity) of Balovaptan is estimated using non-compartmental methods from the concentration-time profiles. Percent extrapolation less than or equal to 20% is required to obtain a reliable AUC0-inf.
Area under the plasma concentration-time curve of Balovaptan from time 0 to 24 hours post-dose is estimated using non-compartmental methods from the concentration-time profiles.
Area under the concentration-time curve (time 0 to time of last quantifiable concentration) of Balovaptan is estimated using non-compartmental methods from the concentration-time profiles.
Time to maximum plasma concentration of Balovaptan is defined as first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units and estimated using non-compartmental methods from the concentration-time profiles.
Last quantifiable concentration is estimated using non-compartmental methods from the concentration-time profiles.
Time to last quantifiable concentration is based on last detectable concentration in the time curve.
Time between dosing and time of first balovaptan plasma concentration is estimated using non-compartmental methods from the concentration-time profiles.
Apparent clearance is estimated using non-compartmental methods from the concentration-time profiles.
Apparent volume of distribution is estimated using non-compartmental methods from the concentration-time profiles.
Terminal phase half-life expressed in time units is estimated using non-compartmental methods from the concentration-time profiles.
Terminal phase rate constant is estimated using non-compartmental methods from the concentration-time profiles.
Amount of Balovaptan in a given volume of plasma.
Absolute oral bioavailability of a single dose A of balovaptan.
Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.
Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.
Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.
AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.
AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.
AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.
Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.
| Arm | Type | Description |
|---|---|---|
| Balovaptan | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Treatment sequence ABC | EXPERIMENTAL | In Period 1 participants will receive 1 tablet of balovaptan after high-fat, high-calorie meal. In Period 2, after 12 to 21 days wash-out, participants will receive 1 tablet of balovaptan after 10-hour fast. In Period 3 participants will receive esomeprazole administered once daily for 6 days and with a single oral dose of balovaptan in the fasted state 1 hour after the fifth esomeprazole dose |
| Treatment sequence BAC | EXPERIMENTAL | In Period 1 participants will receive 1 tablet of balovaptan after 10-hour fast. In Period 2, after 12 to 21 days wash-out, participants will receive 1 tablet of balovaptan after high-fat, high-calorie meal. In Period 3 participants will receive esomeprazole administered once daily for 6 days and with a single oral dose of balovaptan in the fasted state 1 hour after the fifth esomeprazole dose |
| Cohort 1 | EXPERIMENTAL | Participants received the study drug at dose level A in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2. |
| Cohort 2 | EXPERIMENTAL | Participants received the study drug at dose level B in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Balovaptan | DRUG | Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period |
| Placebo | DRUG | Matching placebo |
| Esomeprazole | DRUG | Esomeprazole will be administered once daily for 6 days and with a single dose of balovaptan 1 hour after the fifth esomeprazole dose |
| Oral Balovaptan | DRUG | In Period 1, balovaptan was administered as a single oral dose. In Period 2, balovaptan was administered as an oral dose once daily on Day 1 to Day 14. |
| IV Balovaptan | DRUG | In Period 1, IV infusion of balovaptan was administered after the balovaptan oral dose. In Period 2, IV infusion of balovaptan was administered after the final oral dose of balovaptan. |
| Rifampicin | DRUG | 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. |
| Itraconazole | DRUG | 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. |
Inclusion Criteria: * Participants who have a current diagnosis of PTSD as per DSM-5 criteria, with a score of \>/=33 on the PCL-5 at screening * The index trauma event must have occurred in adulthood, i.e., when the participant was \>/=18 years old * The index trauma event must have occurred at le...
Balovaptan is an investigational small molecule being developed by Roche Holding AG for psychiatric conditions including stress disorders, post-traumatic stress disorder, and autism spectrum disorder. It is currently in Phase 1 clinical development and has been studied in healthy volunteers to evaluate its pharmacokinetics and drug interactions.
Balovaptan is being developed by Roche Holding AG, a pharmaceutical company traded on the OTC market under the ticker RHHBY. The drug is an investigational small molecule in Phase 1 clinical development for psychiatric indications including autism spectrum disorder and stress disorders.
Balovaptan is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All three completed clinical trials for Balovaptan were Phase 1 studies conducted in healthy volunteers to assess pharmacokinetics and drug interactions.
Balovaptan has been studied in three completed Phase 1 clinical trials. These include NCT03579719, NCT03586726, and NCT03764449, all conducted in healthy volunteers in the Netherlands. A fourth trial, NCT04156646, investigated the effects of esomeprazole and food on Balovaptan pharmacokinetics in healthy volunteers in the United States.
Balovaptan is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials for Balovaptan were early-stage studies focused on pharmacokinetics and drug interactions in healthy volunteers, and the drug remains under investigation for psychiatric conditions.
Balovaptan is a small molecule being developed for psychiatric conditions, but its specific molecular target has not been disclosed in the available clinical trial information. The drug is in Phase 1 development for stress disorders, post-traumatic stress disorder, and autism spectrum disorder.