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Also known as Oral Balovaptan
Balovaptan · 2 trials · 2 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.
| 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 |
| 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 |
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 oral small molecule drug developed by Roche Holding AG (ticker RHHBY) for psychiatric conditions. It has been studied in autism spectrum disorder and in post-traumatic stress disorder. It is investigational and has not been approved by the FDA. Balovaptan is also known as oral Balovaptan.
Balovaptan has been studied for autism spectrum disorder and for post-traumatic stress disorder. Its clinical program includes a completed Phase 2 trial in adults with PTSD and a completed Phase 1 pharmacokinetic study in healthy volunteers conducted in the context of autism spectrum disorder. It is investigational and not approved for any use.
Balovaptan targets AVPR1A, the arginine vasopressin receptor 1A. It acts as an antagonist at this receptor, meaning it blocks signaling through it. AVPR1A is a G protein-coupled receptor, and balovaptan is an orally administered small molecule directed against it.
Balovaptan is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical studies of the drug, including the Phase 2 trial in adults with post-traumatic stress disorder and the Phase 1 pharmacokinetic study in healthy volunteers.
Balovaptan is in clinical development and is investigational. Its listed development stage is Phase 1, and its clinical program includes a completed Phase 2 trial in adults with post-traumatic stress disorder and a completed Phase 1 pharmacokinetic study. It has not been approved by the FDA for any indication.
Balovaptan has been evaluated in two completed trials. NCT05401565 was a Phase 2 study of balovaptan in adults with post-traumatic stress disorder, enrolling 29 participants in the United States. NCT04156646 was a Phase 1 study of esomeprazole and food effects on balovaptan pharmacokinetics in 16 healthy volunteers.
Yes. Oral Balovaptan is another name for balovaptan, the small molecule AVPR1A antagonist developed by Roche Holding AG. Both names refer to the same investigational drug, which has been studied in autism spectrum disorder and post-traumatic stress disorder.