Trial · NCT06128954
Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).
NCT06128954, Phase 1, Completed, Orphalan; results first posted 2025-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily). Trials, record NCT06128954. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06128954
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).
- NCT number
- NCT06128954
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- Orphalan
- Conditions
- Wilson's Disease
- Interventions
- 900mg TETA 4HCl Once Daily Formulation, 900mg TETA 4HCl Cuprior®
- First posted
- 2023-11-13
- Last updated
- 2026-08-26
- Results first posted
- 2025-08-15
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Concentrations (AUC) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations. | Up to 48 hours post first dose initiation. | PK parameters derived by non-compartmental methods including: AUC 24 and AUCinf. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48. |
| Primary | Plasma Concentrations (AUC) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations. | Up to 48 hours post first dose initiation. | PK parameters derived by non-compartmental methods including: AUC 24 and AUCinf. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48. |
| Primary | Plasma Concentrations (AUC) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations. | Up to 48 hours post first dose initiation. | PK parameters derived by non-compartmental methods including: AUC 24 and AUCinf. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48. |
| Primary | Pharmacokinetic Parameters (AUC) of TETA in Plasma | Up to 48 hours post first dose initiation. | PK parameters derived by non-compartmental methods including: AUCinf and AUC 24. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48. |
| Primary | Plasma Concentrations (Cmax) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations. | Up to 48 hours post first dose initiation. | PK parameters derived by non-compartmental methods including: Cmax. |
| Primary | Pharmacokinetic Parameters (Time) of TETA in Plasma | Up to 48 hours post first dose initiation. | PK parameters derived by non-compartmental methods including: Thalf and Tmax. |
| Primary | Pharmacokinetic Parameters (Concentration) of TETA in Plasma | Up to 48 hours post first dose initiation. | PK parameters derived by non-compartmental methods including: Clast and Cmax. |
| Primary | Pharmacokinetic Parameters (AUC) of MAT in Plasma | Up to 48 hours post first dose initiation | PK parameters derived by non-compartmental methods including: AUCinf and AUC 24. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48. |
| Primary | Plasma Concentrations (Cmax) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations. | Up to 48 hours post first dose initiation. | PK parameters derived by non-compartmental methods including: Cmax. |
| Primary | Pharmacokinetic Parameters (Time) of MAT in Plasma | Up to 48 hours post first dose initiation | PK parameters derived by non-compartmental methods including: Thalf and Tmax.. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma Concentrations (AUC) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations. | Up to 48 hours post first dose initiation. | h*ng/mL | GEOMETRIC_MEAN | |
| PRIMARY | Plasma Concentrations (AUC) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations. | Up to 48 hours post first dose initiation. | h*ng/mL | GEOMETRIC_MEAN | |
| PRIMARY | Plasma Concentrations (AUC) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations. | Up to 48 hours post first dose initiation. | h*ng/mL | GEOMETRIC_MEAN | |
| PRIMARY | Pharmacokinetic Parameters (AUC) of TETA in Plasma | Up to 48 hours post first dose initiation. | Crossover design, participants exposed to both treatments. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Plasma Concentrations (Cmax) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations. | Up to 48 hours post first dose initiation. | ng/mL | GEOMETRIC_MEAN | |
| PRIMARY | Pharmacokinetic Parameters (Time) of TETA in Plasma | Up to 48 hours post first dose initiation. | Crossover design, participants exposed to both treatments. | Hours | GEOMETRIC_MEAN |
| PRIMARY | Pharmacokinetic Parameters (Concentration) of TETA in Plasma | Up to 48 hours post first dose initiation. | Crossover design, participants exposed to both treatments. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Pharmacokinetic Parameters (AUC) of MAT in Plasma | Up to 48 hours post first dose initiation | Crossover design, participants exposed to both treatments. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Plasma Concentrations (Cmax) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations. | Up to 48 hours post first dose initiation. | ng/mL | GEOMETRIC_MEAN | |
| PRIMARY | Pharmacokinetic Parameters (Time) of MAT in Plasma | Up to 48 hours post first dose initiation | Crossover design, participants exposed to both treatments. | Hours | GEOMETRIC_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Plasma Concentrations (AUC) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations. | Once Daily Dose Formulation (Treatment A) | AUC 24 | 12668.493 | 90% Confidence Interval 10236.595 to 15678.135 | h*ng/mL |
| Plasma Concentrations (AUC) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations. | Cuprior® Comparator (Treatment B) | AUC 24 | 10971.720 | 90% Confidence Interval 8865.542 to 13578.262 | h*ng/mL |
| Plasma Concentrations (AUC) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations. | Once Daily Dose Formulation (Treatment A) | AUCinf | 13561.621 | 90% Confidence Interval 10956.316 to 16786.442 | h*ng/mL |
| Plasma Concentrations (AUC) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations. | Cuprior® Comparator (Treatment B) | AUCinf | 11778.232 | 90% Confidence Interval 9515.532 to 14578.980 | h*ng/mL |
| Plasma Concentrations (AUC) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations. | Once Daily Dose Formulation (Treatment A) | AUC 24 | 19327.926 | 90% Confidence Interval 17712.265 to 21090.962 | h*ng/mL |
| Plasma Concentrations (AUC) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations. | Cuprior® Comparator (Treatment B) | AUC 24 | 25318.882 | 90% Confidence Interval 23202.426 to 27628.396 | h*ng/mL |
| Plasma Concentrations (AUC) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations. | Once Daily Dose Formulation (Treatment A) | AUCinf | 23383.874 | 90% Confidence Interval 21524.239 to 25404.176 | h*ng/mL |
| Plasma Concentrations (AUC) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations. | Cuprior® Comparator (Treatment B) | AUCinf | 30655.260 | 90% Confidence Interval 28217.358 to 33303.790 | h*ng/mL |
| Plasma Concentrations (AUC) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations. | Once Daily Dose Formulation (Treatment A) | AUC 24 | 4966.208 | 90% Confidence Interval 4159.876 to 5928.837 | h*ng/mL |
| Plasma Concentrations (AUC) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations. | Cuprior® Comparator (Treatment B) | AUC 24 | 6310.627 | 90% Confidence Interval 5286.009 to 7533.852 | h*ng/mL |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence 1: Once Daily TETA 4HCl Formulation, Followed by Twice Daily Cuprior® Formulation | 13 | |
| Overall Study | STARTED | Sequence 2: Twice Daily Cuprior® Formulation, Followed by Once Daily TETA 4HCl Formulation | 13 | |
| Overall Study | COMPLETED | Sequence 1: Once Daily TETA 4HCl Formulation, Followed by Twice Daily Cuprior® Formulation | 13 | |
| Overall Study | COMPLETED | Sequence 2: Twice Daily Cuprior® Formulation, Followed by Once Daily TETA 4HCl Formulation | 13 | |
| Overall Study | NOT COMPLETED | Sequence 1: Once Daily TETA 4HCl Formulation, Followed by Twice Daily Cuprior® Formulation | 0 | |
| Overall Study | NOT COMPLETED | Sequence 2: Twice Daily Cuprior® Formulation, Followed by Once Daily TETA 4HCl Formulation | 0 |
Source ClinicalTrials.gov
Adverse events16
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 | Presyncope | Cardiac disorders | Once Daily Dose Formulation (Treatment A) | 0 | 26 | 0 |
| other | Presyncope | Cardiac disorders | Cuprior® Comparator (Treatment B) | 1 | 26 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | Once Daily Dose Formulation (Treatment A) | 0 | 26 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Cuprior® Comparator (Treatment B) | 1 | 26 | 1 |
| other | Aphthous ulcer | Gastrointestinal disorders | Once Daily Dose Formulation (Treatment A) | 1 | 26 | 1 |
| other | Aphthous ulcer | Gastrointestinal disorders | Cuprior® Comparator (Treatment B) | 0 | 26 | 0 |
| other | Epigastric discomfort | Gastrointestinal disorders | Once Daily Dose Formulation (Treatment A) | 1 | 26 | 1 |
| other | Epigastric discomfort | Gastrointestinal disorders | Cuprior® Comparator (Treatment B) | 0 | 26 | 0 |
| other | Nausea | Gastrointestinal disorders | Once Daily Dose Formulation (Treatment A) | 1 | 26 | 1 |
| other | Nausea | Gastrointestinal disorders | Cuprior® Comparator (Treatment B) | 0 | 26 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Once Daily Dose Formulation (Treatment A) | 0 | 26 |
| Total, all-cause mortality | Cuprior® Comparator (Treatment B) | 0 | 26 |
| Total, other adverse events | Once Daily Dose Formulation (Treatment A) | 3 | 26 |
| Total, other adverse events | Cuprior® Comparator (Treatment B) | 3 | 26 |
| Total, serious adverse events | Once Daily Dose Formulation (Treatment A) | 0 | 26 |
| Total, serious adverse events | Cuprior® Comparator (Treatment B) | 0 | 26 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Once Daily Dose Formulation (Treatment A) vs Cuprior® Comparator (Treatment B): deaths from any cause | Trial comparisons |
| Once Daily Dose Formulation (Treatment A) vs Cuprior® Comparator (Treatment B): serious adverse events | Trial comparisons |
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.
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Read this trial from software.
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