Trial · NCT04049578
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Disorder
NCT04049578, Phase 1, Terminated, Hoffmann-La Roche; results first posted 2020-10-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Disorder. Trials, record NCT04049578. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04049578
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Disorder
- NCT number
- NCT04049578
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 2 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Autism Spectrum Disorder
- Interventions
- Balovaptan
- First posted
- 2019-08-08
- Last updated
- 2020-10-14
- Results first posted
- 2020-10-14
- Limitations and caveats
- Study was terminated with 2 participants enrolled. Due to low enrollment number patient analysis are not provided to protect participant confidentiality.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve at Steady State (AUCss) of Balovaptan | Predose, 2, 4, 6 hours postdose at Week 2; predose at Week 6; predose at Week 12; predose at Week 24, predose at Week 54 | |
| Primary | Plasma Concentration of Balovaptan | Predose, 2, 4, 6 hours postdose at Week 2; predose at Week 6; predose at Week 12; predose at Week 24, predose at Week 54 | |
| Primary | Plasma Concentration of M2 Metabolite, as Applicable | Predose, 2, 4, 6 hours postdose at Week 2; predose at Week 6; predose at Week 12; predose at Week 24, predose at Week 54 | |
| Primary | Plasma Concentation of M3 Metabolite | Predose, 2, 4, 6 hours postdose at Week 2; predose at Week 6; predose at Week 12; predose at Week 24, predose at Week 54 | |
| Primary | Plasma Concentration Ratio of M2 to Balovaptan, as Applicable | Predose, 2, 4, 6 hours postdose at Week 2; predose at Week 6; predose at Week 12; predose at Week 24, predose at Week 54 | |
| Primary | Plasma Concentration Ratio of M3 to Balovaptan | Predose, 2, 4, 6 hours postdose at Week 2; predose at Week 6; predose at Week 12; predose at Week 24, predose at Week 54 | |
| Secondary | Number of Participants With Adverse Events | Up to approximately week 20 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve at Steady State (AUCss) of Balovaptan | Predose, 2, 4, 6 hours postdose at Week 2; predose at Week 6; predose at Week 12; predose at Week 24, predose at Week 54 | Due to low enrollment number patient analysis are not provided to protect participant confidentiality. | ||
| PRIMARY | Plasma Concentration of Balovaptan | Predose, 2, 4, 6 hours postdose at Week 2; predose at Week 6; predose at Week 12; predose at Week 24, predose at Week 54 | Due to low enrollment number patient analysis are not provided to protect participant confidentiality. | ||
| PRIMARY | Plasma Concentration of M2 Metabolite, as Applicable | Predose, 2, 4, 6 hours postdose at Week 2; predose at Week 6; predose at Week 12; predose at Week 24, predose at Week 54 | Due to low enrollment number patient analysis are not provided to protect participant confidentiality. | ||
| PRIMARY | Plasma Concentation of M3 Metabolite | Predose, 2, 4, 6 hours postdose at Week 2; predose at Week 6; predose at Week 12; predose at Week 24, predose at Week 54 | Due to low enrollment number patient analysis are not provided to protect participant confidentiality. | ||
| PRIMARY | Plasma Concentration Ratio of M2 to Balovaptan, as Applicable | Predose, 2, 4, 6 hours postdose at Week 2; predose at Week 6; predose at Week 12; predose at Week 24, predose at Week 54 | Due to low enrollment number patient analysis are not provided to protect participant confidentiality. | ||
| PRIMARY | Plasma Concentration Ratio of M3 to Balovaptan | Predose, 2, 4, 6 hours postdose at Week 2; predose at Week 6; predose at Week 12; predose at Week 24, predose at Week 54 | Due to low enrollment number patient analysis are not provided to protect participant confidentiality. | ||
| SECONDARY | Number of Participants With Adverse Events | Up to approximately week 20 | Number of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Balovaptan | 2 | Number of Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Balovaptan | 2 | |
| Overall Study | COMPLETED | Balovaptan | 1 | |
| Overall Study | NOT COMPLETED | Balovaptan | 1 |
Source ClinicalTrials.gov
Adverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood thyroid stimulating hormone increased | Investigations | Balovaptan | 1 | 2 | 1 |
| other | Abnormal weight gain | Metabolism and nutrition disorders | Balovaptan | 1 | 2 | 1 |
| other | Psychomotor hyperactivity | Nervous system disorders | Balovaptan | 1 | 2 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Balovaptan | 1 | 2 | 1 |
| other | Haematoma | Vascular disorders | Balovaptan | 1 | 2 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Balovaptan | 0 | 2 |
| Total, other adverse events | Balovaptan | 2 | 2 |
| Total, serious adverse events | Balovaptan | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04049578
GET https://conductscience.org/api/trials/v1/NCT04049578/registered