Who is sponsoring NCT03808298?

NCT03808298 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT03808298?

Interventions in NCT03808298: Balovaptan therapeutic dose Treatment A, Balovaptan supra-therapeutic dose Treatment B, Active control [moxifloxacin] on Day 2 Treatment C, Active control [Moxifloxacin] on Day 15 Treatment D, Placebo for Balovaptan Treatment C, Placebo for Balovaptan Treatment D, Placebo for Moxifloxacin Treatment A, Placebo for Moxifloxacin Treatment B, Moxifloxacin Treatment C, Placebo for Moxifloxacin Treatment C, Placebo for Moxifloxacin Treatment D, Moxifloxacin Treatment D.

What condition does NCT03808298 study?

NCT03808298 studies Healthy Volunteers.

Is NCT03808298 still recruiting?

NCT03808298 is currently completed. Last updated 24 July 2020.

Are results published for NCT03808298?

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

Last reviewed 2020-07-24 · How we verify

NCT03808298

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

Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects

Completed Phase 1 Results posted Last updated 24 July 2020

What this trial tests

Phase 1 trial testing Balovaptan therapeutic dose Treatment A in Healthy Volunteers in 57 participants. Completed in 13 July 2019.

Timeline

7 February 2019

Primary endpoint
14 June 2019

13 July 2019

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	57
Start date	7 February 2019
Primary completion	14 June 2019
Estimated completion	13 July 2019
Sites	1 location across United States

Drugs / interventions tested

Balovaptan therapeutic dose Treatment A
Balovaptan supra-therapeutic dose Treatment B — full drug profile →
Active control [moxifloxacin] on Day 2 Treatment C — full drug profile →
Active control [Moxifloxacin] on Day 15 Treatment D
Placebo for Balovaptan Treatment C — full drug profile →
Placebo for Balovaptan Treatment D — full drug profile →
Placebo for Moxifloxacin Treatment A
Placebo for Moxifloxacin Treatment B
Moxifloxacin Treatment C
Placebo for Moxifloxacin Treatment C
Placebo for Moxifloxacin Treatment D
Moxifloxacin Treatment D — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 18 to 60, any sex, with Healthy Volunteers. 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.

Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings Primary · Baseline (Predose Day 1), Day 14. (Each treatment period is 15 days.)

Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 14.

Day 14 0.75 hours Pre-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-0.1	-1.89 – 1.64
Placebo	-0.6	-2.35 – 1.18

Day 14 0.5 hours Pre-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-0.1	-1.92 – 1.67
Placebo	0.1	-1.68 – 1.92

Day 14 0.25 hours Pre-dose

Group	Value	95% CI
Dose Level B of Balovaptan	0.2	-1.64 – 2.01
Placebo	-0.1	-1.91 – 1.74

Day 14 0.5 hours Post-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-3.3	-5.15 – -1.52
Placebo	-3.9	-5.73 – -2.09

Day 14 1 hours Post-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-2.5	-4.27 – -0.67
Placebo	-2.3	-4.13 – -0.53

Day 14 2.5 hours Post-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-1.9	-3.71 – -0.10
Placebo	-3.5	-5.33 – -1.71

Day 14 4 hours Post-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-1.0	-2.96 – 0.98
Placebo	-2.1	-4.08 – -0.12

Day 14 8 hours Post-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-9.8	-11.90 – -7.65
Placebo	-9.6	-11.73 – -7.48

Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings Secondary · Baseline (Predose Day 1), Day 1. (Each treatment period is 15 days.)

Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 1.

Day 1 0.5 hours Post-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-2.3	-3.36 – -1.22
Placebo	-3.5	-4.59 – -2.44

Day 1 1 hours Post-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-1.8	-2.78 – -0.89
Placebo	-2.9	-3.89 – -1.99

Day 1 2.5 hours Post-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-0.2	-1.39 – 1.04
Placebo	-2.2	-3.43 – -0.99

Day 1 4 hours Post-dose

Group	Value	95% CI
Dose Level B of Balovaptan	1.1	-0.32 – 2.52
Placebo	-1.4	-2.88 – -0.02

Day 1 8 hours Post-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-8.4	-10.20 – -6.69
Placebo	-11.0	-12.72 – -9.20

Day 1 12 hours Post-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-5.5	-7.70 – -3.32
Placebo	-6.9	-9.12 – -4.75

Day 1 24 hours Post-dose

Group	Value	95% CI
Dose Level B of Balovaptan	-1.3	-2.61 – -0.04
Placebo	-3.0	-4.26 – -1.67

Change-From-Baseline QTcF of Balovaptan at Dose Level A Measurred on 12-Lead ECGs Extracted From Continuous Recordings Secondary · Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)

Change-from-baseline QTcF (ΔΔQTcF) at dose level A of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Days 1 and 14.

Day 1 0.5 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-2.7	-3.75 – -1.68
Placebo	-3.5	-4.59 – -2.44

Day 1 1 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-1.6	-2.51 – -0.68
Placebo	-2.9	-3.89 – -1.99

Day 1 2.5 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-0.6	-1.74 – 0.62
Placebo	-2.2	-3.43 – -0.99

Day 1 4 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-0.2	-1.55 – 1.22
Placebo	-1.4	-2.88 – -0.02

Day 1 8 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-8.7	-10.40 – -6.97
Placebo	-11.0	-12.72 – -9.20

Day 1 12 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-6.2	-8.37 – -4.12
Placebo	-6.9	-9.12 – -4.75

Day 1 24 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-2.6	-3.85 – -1.33
Placebo	-3.0	-4.26 – -1.67

Day 14 0.75 hours Pre-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-1.1	-2.84 – 0.62
Placebo	-0.6	-2.35 – 1.18

Change-From-Baseline Heart Rate Measured on 12-Lead ECGs Extracted From Continuous Recordings Secondary · Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)

Change-from-baseline heart rate at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14.

Day 1 0.5 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	0.2	-0.54 – 0.91
Dose Level B of Balovaptan	0.5	-0.24 – 1.25
Placebo	0.4	-0.34 – 1.17

Day 1 1 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	0.1	-0.64 – 0.87
Dose Level B of Balovaptan	0.0	-0.78 – 0.78
Placebo	0.2	-0.61 – 0.97

Day 1 2.5 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-0.4	-1.29 – 0.54
Dose Level B of Balovaptan	-0.3	-1.28 – 0.60
Placebo	0.1	-0.85 – 1.04

Day 1 4 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-0.4	-1.35 – 0.47
Dose Level B of Balovaptan	0.3	-0.64 – 1.24
Placebo	0.1	-0.83 – 1.05

Day 1 8 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	4.8	3.52 – 6.00
Dose Level B of Balovaptan	4.7	3.43 – 5.97
Placebo	5.4	4.17 – 6.72

Day 1 12 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	7.4	6.02 – 8.80
Dose Level B of Balovaptan	7.9	6.45 – 9.31
Placebo	8.1	6.69 – 9.54

Day 1 24 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	2.2	1.24 – 3.24
Dose Level B of Balovaptan	0.5	-0.49 – 1.55
Placebo	2.8	1.75 – 3.80

Day 14 0.75 hours Pre-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-0.6	-1.81 – 0.64
Dose Level B of Balovaptan	0.9	-0.34 – 2.16
Placebo	1.6	0.35 – 2.86

Change-From-Baseline PR Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings Secondary · Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)

Change-from-baseline PR interval at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Day 1 and 14.

Day 1 0.5 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-1.4	-2.43 – -0.43
Dose Level B of Balovaptan	-0.9	-1.88 – 0.18
Placebo	-0.2	-1.28 – 0.80

Day 1 1 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-0.3	-1.45 – 0.84
Dose Level B of Balovaptan	-0.4	-1.55 – 0.80
Placebo	-0.3	-1.46 – 0.92

Day 1 2.5 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-1.6	-2.79 – -0.40
Dose Level B of Balovaptan	-2.0	-3.22 – -0.74
Placebo	-2.0	-3.26 – -0.79

Day 1 4 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-1.5	-2.76 – -0.33
Dose Level B of Balovaptan	-1.9	-3.12 – -0.62
Placebo	-1.2	-2.44 – 0.07

Day 1 8 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-6.3	-7.80 – -4.72
Dose Level B of Balovaptan	-6.5	-8.08 – -4.91
Placebo	-7.4	-9.02 – -5.84

Day 1 12 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-3.9	-5.75 – -2.09
Dose Level B of Balovaptan	-5.5	-7.39 – -3.60
Placebo	-4.2	-6.10 – -2.32

Day 1 24 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-1.4	-2.76 – -0.01
Dose Level B of Balovaptan	-0.3	-1.73 – 1.07
Placebo	-0.3	-1.70 – 1.11

Day 14 0.75 hours Pre-dose

Group	Value	95% CI
Dose Level A of Balovaptan	3.8	1.84 – 5.69
Dose Level B of Balovaptan	4.5	2.56 – 6.49
Placebo	3.1	1.17 – 5.10

Change-From-Baseline QRS Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings Secondary · Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)

Change-from-baseline QRS interval at dose level A and dose level B of balovapton measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14.

Day 1 0.5 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-0.1	-0.25 – 0.01
Dose Level B of Balovaptan	-0.1	-0.22 – 0.05
Placebo	0.0	-0.15 – 0.12

Day 1 1 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	0.1	-0.06 – 0.20
Dose Level B of Balovaptan	0.1	-0.05 – 0.22
Placebo	-0.1	-0.22 – 0.05

Day 1 2.5 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	0.00	-0.13 – 0.17
Dose Level B of Balovaptan	0.00	-0.17 – 0.14
Placebo	0.1	-0.05 – 0.26

Day 1 4 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	0.0	-0.17 – 0.14
Dose Level B of Balovaptan	0.1	-0.02 – 0.31
Placebo	0.0	-0.14 – 0.19

Day 1 8 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-0.5	-0.83 – -0.16
Dose Level B of Balovaptan	-0.3	-0.66 – 0.03
Placebo	-0.4	-0.74 – -0.05

Day 1 12 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	-0.2	-0.58 – 0.26
Dose Level B of Balovaptan	0.2	-0.25 – 0.63
Placebo	-0.1	-0.55 – 0.32

Day 1 24 hours Post-dose

Group	Value	95% CI
Dose Level A of Balovaptan	0.0	-0.22 – 0.15
Dose Level B of Balovaptan	0.1	-0.04 – 0.33
Placebo	-0.2	-0.37 – 0.01

Day 14 0.75 hours Pre-dose

Group	Value	95% CI
Dose Level A of Balovaptan	0.4	0.03 – 0.79
Dose Level B of Balovaptan	0.6	0.18 – 0.95
Placebo	0.2	-0.18 – 0.60

Number of Categorical Outliers for QTcF Secondary · Up to approximately 20 weeks

The number (percentage) of categorical outliers were participants who had increases in absolute QTcF values \> 450 and ≤ 480 ms, \> 480 and ≤ 500 ms, or \> 500 ms.

QTcF>450 and <=480 ms

Group	Value	95% CI
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	1
Placebo	0

QTcF>480 and <=500 ms

Group	Value	95% CI
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	0
Placebo	00

QTcF>500 ms

Group	Value	95% CI
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	0
Placebo	0

Number of Categorical Outliers for HR Secondary · Up to approximately 20 weeks

Number (percentage) of categorical outliers were participants with a decrease in HR from pre-dose baseline \> 25% to a HR \< 50 bpm; and increase in HR from pre-dose baseline \> 25% to a HR \> 100 bpm.

HR < 50 (bpm) with a decrease in ΔHR > 25%

Group	Value	95% CI
Placebo	0
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	0

HR > 100 (bpm) with an increase in ΔHR > 25%

Group	Value	95% CI
Placebo	0
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	0

Number of Categorical Outliers for PR Secondary · Up to approximately 20 weeks

PR outliers criteria is as an increase of PR from baseline \>25% resulting in PR \>200 ms.

Group	Value	95% CI
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	0
Placebo	0

Number of Categorical Outliers for QRS Secondary · Up to approximately 20 weeks

QRS outlier criteria is an increase of QRS from baseline \>25% resulting in QRS \>120 ms.

Group	Value	95% CI
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	0
Placebo	0

Number of Treatment Emergent Changes of T-Wave Morphology Secondary · Up to approximately 20 weeks

Number (%) of participants falling into each of the T-wave categories: Normal (+), Flat, Notched (+), Biphasic, Normal (-), Notched (-).

Flat T-wave

Group	Value	95% CI
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	1
Placebo	1

Notched T-wave (+)

Group	Value	95% CI
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	0
Placebo	0

Biphasic T-wave

Group	Value	95% CI
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	1
Placebo	0

Normal T-wave (-)

Group	Value	95% CI
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	0
Placebo	0

Notched T-wave (-)

Group	Value	95% CI
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	0
Placebo	0

Number of Treatment Emergent Changes of U-Wave Presence Secondary · Up to approximately 20 weeks

Number (percentage) of participants with treatment emergent changes of U-wave presence.

Group	Value	95% CI
Dose Level A of Balovaptan	0
Dose Level B of Balovaptan	0
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first study drug to the data cutoff date: 13 July 2019 (up to 20 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment A Dose Level A

Serious: 0/55 (0%)

Deaths: 0/55

Treatment B Dose Level B

Serious: 0/52 (0%)

Deaths: 0/52

Treatment C Placebo + Moxifloxacin 400 mg Day 2

Serious: 0/26 (0%)

Deaths: 0/26

Treatment D Placebo + Moxifloxacin 400 mg Day 15

Serious: 0/26 (0%)

Deaths: 0/26

All Participants

Serious: 0/57 (0%)

Deaths: 0/57

Other adverse events (2 terms — click to expand)

Reaction	System	Treatment A Dose Level A	Treatment B Dose Level B	Treatment C Placebo + Moxi…	Treatment D Placebo + Moxi…	All Participants
Headache	Nervous system disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT03808298 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A population pharmacokinetics model of balovaptan to support dose selection in adult and pediatric populations.
Schaedeli Stark F, Chavanne C, Derks M, Jolling K, et al · · 2024 · cited 1× · PMID 38308741 · DOI 10.1007/s10928-023-09898-0

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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 NCT03808298 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
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: 24 July 2020

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/NCT03808298.

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

NCT03808298

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 recruiting trials for Healthy Volunteers

Other Hoffmann-La Roche trials

Verify against primary sources