NCT04156646 is a Phase 1 clinical trial of Balovaptan in Autism Spectrum Disorder, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT04156646?

NCT04156646 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT04156646?

Interventions in NCT04156646: Balovaptan, Esomeprazole.

What condition does NCT04156646 study?

NCT04156646 studies Autism Spectrum Disorder.

Is NCT04156646 still recruiting?

NCT04156646 is currently completed. Last updated 16 March 2021.

Are results published for NCT04156646?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-03-16 · How we verify

NCT04156646

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 16 March 2021

What this trial tests

Phase 1 trial testing Balovaptan in Autism Spectrum Disorder in 16 participants. Completed in 6 January 2020.

Timeline

19 November 2019

Primary endpoint
24 December 2019

6 January 2020

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	19 November 2019
Primary completion	24 December 2019
Estimated completion	6 January 2020
Sites	1 location across United States

Drugs / interventions tested

Balovaptan — full drug profile →
Esomeprazole (esomeprazole) — full drug profile →

Conditions studied

Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 18 to 65, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Plasma Concentration (Cmax) of Balovaptan Primary · Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose

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

Group	Value	95% CI
Balovaptan 20 mg Fed	74.83	± 42.6
Balovaptan 20 mg Fasted	97.44	± 44.6
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted	79.67	± 38.3

Mean Area Under the Concentration-Time Curve From Time Extrapolated to Infinity (AUC (0-inf)) of Balovaptan Primary · Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose

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.

Group	Value	95% CI
Balovaptan 20 mg Fed	1736.7	± 51.3
Balovaptan 20 mg Fasted	1705.7	± 55.9
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted	1820.0	± 46.9

Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC(0-24h)) of Balovaptan Primary · Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post dose

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.

Group	Value	95% CI
Balovaptan 20 mg Fed	935.2	± 31.7
Balovaptan 20 mg Fasted	945.2	± 30.8
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted	965.0	± 30.7

Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Balovaptan Primary · Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose

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.

Group	Value	95% CI
Balovaptan 20 mg Fed	1671.0	± 50.2
Balovaptan 20 mg Fasted	1636.1	± 53.3
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted	1650.9	± 48.3

Time to Reach Cmax in Plasma (Tmax) of Balovaptan Primary · Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose

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.

Group	Value	95% CI
Balovaptan 20 mg Fed	4.50	0.50 – 8.00
Balovaptan 20 mg Fasted	1.00	0.50 – 3.00
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted	1.75	1.00 – 4.00

Last Quantifiable Concentration (Clast) of Balovaptan Primary · Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose

Last quantifiable concentration is estimated using non-compartmental methods from the concentration-time profiles.

Group	Value	95% CI
Balovaptan 20 mg Fed	1.693	± 45.2
Balovaptan 20 mg Fasted	1.745	± 57.3
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted	2.253	± 142.8

Time To the Last Quantifiable Concentration (Tlast) of Balovaptan Primary · Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose

Time to last quantifiable concentration is based on last detectable concentration in the time curve.

Group	Value	95% CI
Balovaptan 20 mg Fed	115.86	± 33.4
Balovaptan 20 mg Fasted	113.79	± 35.0
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted	103.58	± 41.0

Time Between Dosing and Time of First Balovaptan Plasma Concentration (Tlag) Primary · Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose

Time between dosing and time of first balovaptan plasma concentration is estimated using non-compartmental methods from the concentration-time profiles.

Group	Value	95% CI
Balovaptan 20 mg Fed	0.2500	0.0 – 1.5
Balovaptan 20 mg Fasted	0.2500	0.0 – 0.5
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted	0.2500	0.0 – 0.5

Apparent Clearance (Cl/F) of Balovaptan Primary · Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose

Apparent clearance is estimated using non-compartmental methods from the concentration-time profiles.

Group	Value	95% CI
Balovaptan 20 mg Fed	11.51	± 35.7
Balovaptan 20 mg Fasted	11.73	± 36.3
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted	11.26	± 32.2

Apparent Volume of Distribution (Vd/F) of Balovaptan Primary · Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose

Apparent volume of distribution is estimated using non-compartmental methods from the concentration-time profiles.

Group	Value	95% CI
Balovaptan 20 mg Fed	422.7	± 28.7
Balovaptan 20 mg Fasted	422.5	± 33.4
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted	429.4	± 18.5

Terminal Elimination Phase Half-Life (T1/2) of Balovaptan Primary · Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose

Terminal phase half-life expressed in time units is estimated using non-compartmental methods from the concentration-time profiles.

Group	Value	95% CI
Balovaptan 20 mg Fed	25.44	± 40.0
Balovaptan 20 mg Fasted	24.98	± 47.0
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted	27.26	± 40.9

Maximum Plasma Concentration (Cmax) of M2 Metabolite Secondary · Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose

Maximum plasma concentration of M2 Metabolite is estimated using non-compartmental methods. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units

Group	Value	95% CI
Balovaptan 20 mg Fed	11.27	± 27.0
Balovaptan 20 mg Fasted	11.44	± 30.8
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted	11.68	± 30.1

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline to end of study (up to approximately 7 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Balovaptan 20 mg Fed

Serious: 0/16 (0%)

Deaths: 0/16

Balovaptan 20 mg Fasted

Serious: 0/16 (0%)

Deaths: 0/16

Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (4 terms — click to expand)

Reaction	System	Balovaptan 20 mg Fed	Balovaptan 20 mg Fasted	Balovaptan 20 mg Fasted + …
Eye Pain	Eye disorders	—	—	—
Gastroenteritis	Infections and infestations	—	—	—
Tooth fracture	Injury, poisoning and procedural complications	—	—	—
Headache	Nervous system disorders	—	—	—

Data from ClinicalTrials.gov NCT04156646 adverse events section.

Sponsor's own description

This study will investigate the effect of food and the effect of esomeprazole on the pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Balovaptan

Trials testing the same drug.

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NCT04049578 — A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Dis · Phase 1 · terminated
NCT03504917 — A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension · Phase 3 · terminated

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Other Hoffmann-La Roche trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04156646 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 16 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04156646.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04156646

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Balovaptan

Other recruiting trials for Autism Spectrum Disorder

Other Hoffmann-La Roche trials

Verify against primary sources