Balovaptan

DRUG8 trials

Sponsors

Hoffmann-La Roche

Conditions

Acute Ischemic StrokeAutism Spectrum DisorderHealthy VolunteersStress Disorders, Post-Traumatic

Phase 1

A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers

CompletedNCT03579719

Hoffmann-La RocheHealthy Volunteers

Start: 2018-07-10End: 2018-11-09Updated: 2019-11-04

A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers

CompletedNCT03586726

Hoffmann-La RocheHealthy Volunteers

Start: 2018-07-24End: 2018-11-15Updated: 2019-11-07

The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan

WithdrawnNCT03912350

Hoffmann-La RocheAutism Spectrum Disorder

Start: 2022-06-26End: 2022-10-13Updated: 2022-02-08

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Disorder

TerminatedNCT04049578

Hoffmann-La RocheAutism Spectrum Disorder

Start: 2019-12-19End: 2020-05-06Updated: 2020-10-14

A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers

CompletedNCT04156646

Hoffmann-La RocheAutism Spectrum Disorder

Start: 2019-11-19End: 2020-01-06Updated: 2021-03-16

Phase 2

Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema

WithdrawnNCT05399550

Hoffmann-La RocheAcute Ischemic Stroke

Start: 2022-06-22End: 2022-11-17Updated: 2023-08-07

Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)

CompletedNCT05401565

Hoffmann-La RocheStress Disorders, Post-Traumatic

Start: 2022-08-02End: 2023-10-05Updated: 2024-04-18

Phase 3

A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

TerminatedNCT03504917

Hoffmann-La RocheAutism Spectrum Disorder

Start: 2018-08-08End: 2020-07-01Updated: 2021-10-27

Related Papers

Anxiety, repetitive and restricted behaviors and interests, and social communication in autistic adults: an exploratory analysis of a phase 3, randomized clinical trial.

2025-11-06

Efficacy and safety of balovaptan for posttraumatic stress disorder: A randomized, placebo-controlled trial.

Experimental and Clinical Psychopharmacology2024-11-12

Efficacy and safety of balovaptan for socialisation and communication difficulties in autistic adults in North America and Europe: a phase 3, randomised, placebo-controlled trial.

2022-02-1018 citations

Open-Label Assessment of the Effects of Itraconazole and Rifampicin on Balovaptan Pharmacokinetics in Healthy Volunteers.

2020-09-153 citations