CLINICAL TRIALS PROFILE FOR BALOVAPTAN

Clinical Trials for Balovaptan

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02901431 ↗	A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants With Autism Spectrum Disorder (ASD)	Terminated	Hoffmann-La Roche	Phase 2	For participants enrolled prior to Version 6 of the protocol: This was a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of balovaptan in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence quotient [IQ] greater than or equal to [>=] 70). For participants enrolled according to Version 6 of the protocol: This was a Phase II multi-center, randomized, double-blind, 24-week, parallel group, placebo-controlled, 2-arm study with participants assigned either to a 10 milligram (mg) or equivalent dose of balovaptan, or placebo. All other study parameters remained as stated above. There are three parts to this study: PK Part (Study part 1) included up to 8 weeks of treatment, Main Treatment Part (Study part 2) included 24 week of treatment, and the Open Label Extension Part (Study part 3) included Week 24 to Week 76 of treatment. All participants that completed the 24-week treatment period were eligible to participate in an optional 52-week open-label extension (OLE) during which they received balovaptan treatment.
NCT03504917 ↗	A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension	Terminated	Hoffmann-La Roche	Phase 3	This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).
NCT03579719 ↗	A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers	Completed	Hoffmann-La Roche	Phase 1	This study was a non-randomized, open-label, one-sequence, two-period within-subject study to investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female volunteers using itraconazole as a CYP3A inhibitor. The study was conducted at 1 site in the Netherlands.
NCT03586726 ↗	A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers	Completed	Hoffmann-La Roche	Phase 1	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.
NCT03764449 ↗	A Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers	Completed	Hoffmann-La Roche	Phase 1	This study was a non-randomized, open-label, parallel group, two-treatment study in healthy volunteers to investigate the absolute oral bioavailability of balovaptan. The study was conducted at 1 site in the Netherlands.
NCT03808298 ↗	Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects	Completed	Hoffmann-La Roche	Phase 1	This was a single-center, multiple-dose, randomized, double-blind, placebo-controlled, positive-controlled, twelve sequence, 3-period cross-over study to investigate the effect of balovaptan on the QTc interval in healthy subjects.
NCT03912350 ↗	The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan	Withdrawn	Hoffmann-La Roche	Phase 1	This is a multi-center, non-randomized, open-label, parallel group, multiple-dose study to assess the pharmacokinetic, safety, and tolerability of balovaptan in male and female subjects with moderate hepatic impairment compared to healthy subjects with normal hepatic function matched by age (±10 years), sex, and body mass index (BMI; ±20%).

Clinical Trial Conditions for Balovaptan

Condition Name

Condition Name
Intervention	Trials
Autism Spectrum Disorder	5
Healthy Volunteers	4
Acute Ischemic Stroke	2
Stress Disorders, Post-Traumatic	1

Condition MeSH

Condition MeSH
Intervention	Trials
Autism Spectrum Disorder	5
Disease	3
Child Development Disorders, Pervasive	3
Autistic Disorder	3

Clinical Trial Locations for Balovaptan

Trials by Country

Trials by Country
Location	Trials
United States	74
Italy	6
Spain	5
Canada	3
Netherlands	3

Trials by US State

Trials by US State
Location	Trials
Texas	4
Tennessee	4
Ohio	4
New York	4
Florida	4

Clinical Trial Progress for Balovaptan

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	4
Phase 1	7

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	5
Not yet recruiting	3
Terminated	3

Clinical Trial Sponsors for Balovaptan

Sponsor Name

Sponsor Name
Sponsor	Trials
Hoffmann-La Roche	12

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	12