Trial · NCT05418829
AT-007 in Adult Subjects With Classic Galactosemia (CG)
NCT05418829, Phase 3, Unknown, Applied Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AT-007 in Adult Subjects With Classic Galactosemia (CG). Trials, record NCT05418829. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05418829
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AT-007 in Adult Subjects With Classic Galactosemia (CG)
- NCT number
- NCT05418829
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 7 participants, actual
- Lead sponsor
- Applied Therapeutics, Inc.
- Conditions
- Classic Galactosemia
- Interventions
- AT-007
- First posted
- 2022-06-14
- Last updated
- 2022-06-14
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the long-term safety of 12-month oral administration of AT-007 in adult subjects with CG as assessed by adverse events. | 12 months | Number of participants with treatment-emergent adverse events and broken down by organ class and relatedness. |
| Primary | To evaluate the long-term safety of 12-month oral administration of AT-007 in adult subjects with CG as assessed by clinical laboratory test results. | 12 months | Number of participants with clinically-significant changes in clinical laboratory test results. |
| Primary | To evaluate the long-term safety of 12-month oral administration of AT-007 in adult subjects with CG as assessed by physical exam parameters. | 12 months | Number of participants with clinically-significant changes in physical examination findings, vital sign abnormalities, and electrocardiogram findings. |
| Secondary | To evaluate the long-term change of galactitol, a biomarker of AR activity, induced by 12-month oral administration of AT-007 to adult subjects with CG | 12 months | |
| Secondary | To evaluate the pharmacokinetic (PK) parameter maximum concentration (Cmax) of 12-month oral administration of AT-007 in adult subjects with CG | 12 months | Maximum concentration will be determined by individual concentration time-data (mg/L) |
| Secondary | To evaluate the pharmacokinetic (PK) parameter Area-Under-the-Curve (AUC) of 12-month oral administration of AT-007 in adult subjects with CG (mg*h/L) | 12 months | |
| Other | To evaluate the effect of 12-month oral administration of AT-007 on the levels of galactose and its other metabolites in adult subjects with CG | 12 months | |
| Other | To evaluate the burden of illness (BOI) of adult subjects with CG- Medical History | 12 months | Narrative description of natural course of CG as extracted by chart review and physical exam findings noted in chart review including the baseline neurologic exam upon entering the clinical trial. (There are no units for a descriptive narrative of medical history) |
| Other | To evaluate the burden of illness (BOI) of adult subjects with CG- NIH Motor Battery | 12 months | NIH Motor Battery produces normalized percentile scores with higher scores being more normal. As an exploratory endpoint, changes in the score from baseline to month 12 will assessed. |
| Other | To evaluate the burden of illness (BOI) of adult subjects with CG- Spiral Drawing Test | 12 months | Spiral Drawing Test produces normalized percentile scores with higher scores being more normal. As an exploratory endpoint, changes in the score from baseline to month 12 will assessed. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Spiral Drawing Test | Other outcome |
Source ConductCognition
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/NCT05418829
GET https://conductscience.org/api/trials/v1/NCT05418829/registered