Trial Outcomes & Findings for Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily). (NCT NCT06128954)
NCT ID: NCT06128954
Last Updated: 2026-08-26
Results Overview
PK parameters derived by non-compartmental methods including: Clast and Cmax..
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Up to 48 hours post first dose initiation
Results posted on
2026-08-26
Participant Flow
Participant milestones
| Measure |
Sequence 2: Twice Daily Cuprior® Formulation, Followed by Once Daily TETA 4HCl Formulation
Participants first received 2 x 450mg TETA 4HCl, marketed Cuprior® formulation (6 x150mg trientine base tablets in two equally divided doses (450mg doses 8 hours apart), for 3 days. After a washout period of a minimum of 5 days and up to 10 days, they then received 1 x 900mg TETA 4HCl, once daily formulation (3x300mg trientine base tablets as a single AM dose) for 3 days.
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Sequence 1: Once Daily TETA 4HCl Formulation, Followed by Twice Daily Cuprior® Formulation
Participants first received 1 x 900mg TETA 4HCl, once daily formulation (3x300mg trientine base tablets as a single AM dose), for 3 days. After a washout period of a minimum of 5 days and up to 10 days, they then received 2 x 450mg TETA 4HCl, marketed Cuprior® formulation (6 x150mg trientine base tablets in two equally divided doses (450mg doses 8 hours apart) for 3 days.
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|---|---|---|
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Overall Study
STARTED
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13
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13
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Overall Study
COMPLETED
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13
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13
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).
Baseline characteristics by cohort
| Measure |
Sequence 1: Once Daily TETA 4HCl Formulation, Followed by Twice Daily Cuprior® Formulation
n=13 Participants
Participants first received 1 x 900mg TETA 4HCl, once daily formulation (3x300mg trientine base tablets as a single AM dose), for 3 days. After a washout period of a minimum of 5 days and up to 10 days, they then received 2 x 450mg TETA 4HCl, marketed Cuprior® formulation (6 x150mg trientine base tablets in two equally divided doses (450mg doses 8 hours apart) for 3 days.
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Sequence 2: Twice Daily Cuprior® Formulation, Followed by Once Daily TETA 4HCl Formulation
n=13 Participants
Participants first received 2 x 450mg TETA 4HCl, marketed Cuprior® formulation (6 x150mg trientine base tablets in two equally divided doses (450mg doses 8 hours apart), for 3 days. After a washout period of a minimum of 5 days and up to 10 days, they then received 1 x 900mg TETA 4HCl, once daily formulation (3x300mg trientine base tablets as a single AM dose) for 3 days.
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Total
n=26 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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26.4 years
STANDARD_DEVIATION 5.82 • n=31 Participants
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28.5 years
STANDARD_DEVIATION 5.91 • n=49 Participants
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27.4 years
STANDARD_DEVIATION 5.85 • n=80 Participants
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Sex: Female, Male
Female
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7 Participants
n=31 Participants
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6 Participants
n=49 Participants
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13 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=31 Participants
|
7 Participants
n=49 Participants
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13 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=31 Participants
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0 Participants
n=49 Participants
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2 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=31 Participants
|
13 Participants
n=49 Participants
|
24 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=31 Participants
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1 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=31 Participants
|
4 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=31 Participants
|
5 Participants
n=49 Participants
|
15 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
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0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=31 Participants
|
3 Participants
n=49 Participants
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5 Participants
n=80 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
|
Plasma Concentrations (AUC) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations.
AUC 24
|
12668.493 h*ng/mL
Interval 10236.595 to 15678.135
|
10971.720 h*ng/mL
Interval 8865.542 to 13578.262
|
|
Plasma Concentrations (AUC) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations.
AUCinf
|
13561.621 h*ng/mL
Interval 10956.316 to 16786.442
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11778.232 h*ng/mL
Interval 9515.532 to 14578.98
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
|
Plasma Concentrations (AUC) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations.
AUC 24
|
19327.926 h*ng/mL
Interval 17712.265 to 21090.962
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25318.882 h*ng/mL
Interval 23202.426 to 27628.396
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Plasma Concentrations (AUC) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations.
AUCinf
|
23383.874 h*ng/mL
Interval 21524.239 to 25404.176
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30655.260 h*ng/mL
Interval 28217.358 to 33303.79
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
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Plasma Concentrations (AUC) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations.
AUC 24
|
4966.208 h*ng/mL
Interval 4159.876 to 5928.837
|
6310.627 h*ng/mL
Interval 5286.009 to 7533.852
|
|
Plasma Concentrations (AUC) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations.
AUCinf
|
6285.164 h*ng/mL
Interval 5358.373 to 7372.253
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8324.132 h*ng/mL
Interval 7096.681 to 9763.883
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PRIMARY outcome
Timeframe: Up to 48 hours post first dose initiation.Population: Crossover design, participants exposed to both treatments.
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.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
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|---|---|---|
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Pharmacokinetic Parameters (AUC) of TETA in Plasma
AUCinf
|
13561.621 h*ng/mL
Geometric Coefficient of Variation 48.627
|
11778.232 h*ng/mL
Geometric Coefficient of Variation 45.404
|
|
Pharmacokinetic Parameters (AUC) of TETA in Plasma
AUC 24
|
12668.493 h*ng/mL
Geometric Coefficient of Variation 49.498
|
10971.720 h*ng/mL
Geometric Coefficient of Variation 45.807
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PRIMARY outcome
Timeframe: Up to 48 hours post first dose initiation.PK parameters derived by non-compartmental methods including: Cmax.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
|
Plasma Concentrations (Cmax) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations.
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3435.621 ng/mL
Interval 2876.753 to 4103.061
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1567.145 ng/mL
Interval 1312.22 to 1871.595
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PRIMARY outcome
Timeframe: Up to 48 hours post first dose initiation.Population: Crossover design, participants exposed to both treatments.
PK parameters derived by non-compartmental methods including: Thalf and Tmax.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
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Pharmacokinetic Parameters (Time) of TETA in Plasma
Tmax
|
0.8874 Hours
Geometric Coefficient of Variation 73.6544
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1.9438 Hours
Geometric Coefficient of Variation 116.0599
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Pharmacokinetic Parameters (Time) of TETA in Plasma
Thalf
|
15.593 Hours
Geometric Coefficient of Variation 30.461
|
8.643 Hours
Geometric Coefficient of Variation 49.617
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PRIMARY outcome
Timeframe: Up to 48 hours post first dose initiation.Population: Crossover design, participants exposed to both treatments.
PK parameters derived by non-compartmental methods including: Clast and Cmax.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
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Pharmacokinetic Parameters (Concentration) of TETA in Plasma
Clast
|
16.040 ng/mL
Geometric Coefficient of Variation 45.710
|
17.382 ng/mL
Geometric Coefficient of Variation 44.905
|
|
Pharmacokinetic Parameters (Concentration) of TETA in Plasma
Cmax
|
3436 ng/mL
Geometric Coefficient of Variation 41
|
1567 ng/mL
Geometric Coefficient of Variation 45
|
PRIMARY outcome
Timeframe: Up to 48 hours post first dose initiationPopulation: Crossover design, participants exposed to both treatments.
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.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
|
Pharmacokinetic Parameters (AUC) of MAT in Plasma
AUCinf
|
23383.874 h*ng/mL
Geometric Coefficient of Variation 27.676
|
30655.260 h*ng/mL
Geometric Coefficient of Variation 22.052
|
|
Pharmacokinetic Parameters (AUC) of MAT in Plasma
AUC 24
|
19327.926 h*ng/mL
Geometric Coefficient of Variation 29.416
|
25318.882 h*ng/mL
Geometric Coefficient of Variation 22.149
|
PRIMARY outcome
Timeframe: Up to 48 hours post first dose initiation.PK parameters derived by non-compartmental methods including: Cmax.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
|
Plasma Concentrations (Cmax) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations.
|
2030.958 ng/mL
Interval 1849.766 to 2229.898
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2058.668 ng/mL
Interval 1875.003 to 2260.323
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PRIMARY outcome
Timeframe: Up to 48 hours post first dose initiationPopulation: Crossover design, participants exposed to both treatments.
PK parameters derived by non-compartmental methods including: Thalf and Tmax..
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
|
Pharmacokinetic Parameters (Time) of MAT in Plasma
Tmax
|
3.8785 Hours
Geometric Coefficient of Variation 26.4810
|
13.0875 Hours
Geometric Coefficient of Variation 12.7188
|
|
Pharmacokinetic Parameters (Time) of MAT in Plasma
Thalf
|
13.852 Hours
Geometric Coefficient of Variation 27.030
|
9.045 Hours
Geometric Coefficient of Variation 16.633
|
PRIMARY outcome
Timeframe: Up to 48 hours post first dose initiationPopulation: Crossover design, participants exposed to both treatments.
PK parameters derived by non-compartmental methods including: Clast and Cmax..
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
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Pharmacokinetic Parameters (Concentration) of MAT in Plasma
Clast
|
67.119 ng/mL
Geometric Coefficient of Variation 32.127
|
81.886 ng/mL
Geometric Coefficient of Variation 36.080
|
|
Pharmacokinetic Parameters (Concentration) of MAT in Plasma
Cmax
|
2031 ng/mL
Geometric Coefficient of Variation 32
|
2059 ng/mL
Geometric Coefficient of Variation 23
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PRIMARY outcome
Timeframe: Up to 48 hours post first dose initiation.Population: Crossover design, participants exposed to both treatments.
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.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
|
Pharmacokinetic Parameters (AUC) of DAT in Plasma
AUCinf
|
6285.164 h*ng/mL
Geometric Coefficient of Variation 51.082
|
8324.132 h*ng/mL
Geometric Coefficient of Variation 50.170
|
|
Pharmacokinetic Parameters (AUC) of DAT in Plasma
AUC 24
|
4966.208 h*ng/mL
Geometric Coefficient of Variation 56.026
|
6310.627 h*ng/mL
Geometric Coefficient of Variation 55.882
|
PRIMARY outcome
Timeframe: Up to 48 hours post first dose initiation.PK parameters derived by non-compartmental methods including: Cmax.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
|
Plasma Concentrations (Cmax) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations.
|
443.208 ng/mL
Interval 362.437 to 541.979
|
450.705 ng/mL
Interval 368.568 to 551.147
|
PRIMARY outcome
Timeframe: Up to 48 hours post first dose initiation.Population: Crossover design, participants exposed to both treatments.
PK parameters derived by non-compartmental methods including: Thalf and Tmax.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
|
Pharmacokinetic Parameters (Time) of DAT in Plasma
Thalf
|
11.053 Hours
Geometric Coefficient of Variation 14.335
|
8.529 Hours
Geometric Coefficient of Variation 11.086
|
|
Pharmacokinetic Parameters (Time) of DAT in Plasma
Tmax
|
5.3587 Hours
Geometric Coefficient of Variation 14.9105
|
12.3653 Hours
Geometric Coefficient of Variation 20.6338
|
PRIMARY outcome
Timeframe: Up to 48 hours post first dose initiation.Population: Crossover design, participants exposed to both treatments.
PK parameters derived by non-compartmental methods including: Clast and Cmax.
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
|
Pharmacokinetic Parameters (Concentration) of DAT in Plasma
Clast
|
22.899 ng/mL
Geometric Coefficient of Variation 33.640
|
30.100 ng/mL
Geometric Coefficient of Variation 37.799
|
|
Pharmacokinetic Parameters (Concentration) of DAT in Plasma
Cmax
|
443 ng/mL
Geometric Coefficient of Variation 64
|
451 ng/mL
Geometric Coefficient of Variation 63
|
SECONDARY outcome
Timeframe: Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.The incidence, severity, and relationship of Treatment-Emergent Adverse Events (TEAEs).
Outcome measures
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 Participants
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 Participants
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
|
To Compare the Safety and Tolerability of the Two TETA 4HCL Tablet Formulations.
Participants with morphological and/or rhythm abnormalities on electrocardiogram (ECG)
|
0 Participants
|
0 Participants
|
|
To Compare the Safety and Tolerability of the Two TETA 4HCL Tablet Formulations.
Participants with treatment-related TEAEs.
|
2 Participants
|
1 Participants
|
|
To Compare the Safety and Tolerability of the Two TETA 4HCL Tablet Formulations.
Participants with clinically significant changes in laboratory safety tests
|
0 Participants
|
0 Participants
|
|
To Compare the Safety and Tolerability of the Two TETA 4HCL Tablet Formulations.
Participants with clinically significant changes in vital signs
|
0 Participants
|
1 Participants
|
Adverse Events
Once Daily Dose Formulation (Treatment A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cuprior® Comparator (Treatment B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Once Daily Dose Formulation (Treatment A)
n=26 participants at risk
1 x 900mg TETA 4HCl, new once daily formulation (3x300mg trientine base tablets as a single AM dose)
900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose
|
Cuprior® Comparator (Treatment B)
n=26 participants at risk
2 x 450mg TETA 4HCl, Marketed Cuprior® formulation (6 x150mg trientine base tablets in two equally divided doses (450mg doses 8 hours apart)
900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses
|
|---|---|---|
|
Cardiac disorders
Presyncope
|
0.00%
0/26 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/26 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
0.00%
0/26 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
0.00%
0/26 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
0.00%
0/26 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/26 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/26 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/26 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Full study agreement in place with Richmond Pharmacology.
- Publication restrictions are in place
Restriction type: OTHER