Trial · NCT06128954
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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.. |
| Primary | Pharmacokinetic Parameters (Concentration) of MAT 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 DAT 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, 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: Cmax. |
| Primary | Pharmacokinetic Parameters (Time) of DAT 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 DAT in Plasma | Up to 48 hours post first dose initiation. | PK parameters derived by non-compartmental methods including: Clast and Cmax. |
| Secondary | To Compare the Safety and Tolerability of the Two TETA 4HCL Tablet Formulations. | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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