Trial · NCT06135675
PK Profile and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia
NCT06135675, Phase 1, Phase 2, Completed, TenNor Therapeutics (Suzhou) Limited; results first posted 2024-05-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PK Profile and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia. Trials, record NCT06135675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06135675
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PK Profile and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia
- NCT number
- NCT06135675
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- TenNor Therapeutics (Suzhou) Limited
- Conditions
- Hyperammonemia
- Interventions
- TNP-2092 capsules, Placebo
- First posted
- 2023-11-18
- Last updated
- 2025-04-25
- Results first posted
- 2024-05-10
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of TNP-2092 by Assessment of the Number of Participants With Adverse Events (AEs) | Up to 17 days after the first dosing. | To investigate the safety and tolerability of TNP-2092 by assessment of the number of participants with AEs following administration of TNP-2092 capsules. An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia on Day 1. | Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose | Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. |
| Primary | Area Under the Plasma Concentration-time Curve From the Time of Administration to the Time of the Last Measurable Plasma Concentration (AUC0-last) on Day 1. | Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose | Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. |
| Primary | Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) on Day 15 | Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose | Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. |
| Primary | Time to Reach the Maximum Observed Plasma Concentration (Tmax) on Day 1 | Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose | Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia on Day 15. | Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose | Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. |
| Primary | Area Under the Plasma Concentration-time Curve From the Time of Administration to the Time of the Last Measurable Plasma Concentration (AUC0-last) on Day 15. | Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose | Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. |
| Primary | Time to Reach the Maximum Observed Plasma Concentration (Tmax) Day 15 | Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose | Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. |
| Primary | Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) Day 1 | Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose | Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. |
| Primary | Half Life (t1/2) of TNP-2092 Capsules on Day 1 | Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose | Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety of TNP-2092 by Assessment of the Number of Participants With Adverse Events (AEs) | Up to 17 days after the first dosing. | All subjects who have received at least one dose of study drug. | participants | NUMBER |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia on Day 1. | Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose | All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter. | ng/ml | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From the Time of Administration to the Time of the Last Measurable Plasma Concentration (AUC0-last) on Day 1. | Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose | All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter. | h*ng/ml | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) on Day 15 | Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose | All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter. | h*ng/ml | MEAN |
| PRIMARY | Time to Reach the Maximum Observed Plasma Concentration (Tmax) on Day 1 | Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose | All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter. | h | MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia on Day 15. | Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose | All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter. | ng/ml | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From the Time of Administration to the Time of the Last Measurable Plasma Concentration (AUC0-last) on Day 15. | Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose | All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter. | h*ng/ml | MEAN |
| PRIMARY | Time to Reach the Maximum Observed Plasma Concentration (Tmax) Day 15 | Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose | All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter. | h | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) Day 1 | Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose | All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter. | h*ng/ml | MEAN |
| PRIMARY | Half Life (t1/2) of TNP-2092 Capsules on Day 1 | Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose | All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter. | h | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group186
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety of TNP-2092 by Assessment of the Number of Participants With Adverse Events (AEs) | TNP-2092 Capsules 100mg Twice Daily(BID) | 6 | participants | ||
| Safety of TNP-2092 by Assessment of the Number of Participants With Adverse Events (AEs) | TNP-2092 Capsules 300mg BID | 6 | participants | ||
| Safety of TNP-2092 by Assessment of the Number of Participants With Adverse Events (AEs) | TNP-2092 Capsules 600mg BID | 7 | participants | ||
| Safety of TNP-2092 by Assessment of the Number of Participants With Adverse Events (AEs) | Placebo | 8 | participants | ||
| Maximum Observed Plasma Concentration (Cmax) of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia on Day 1. | TNP-2092 Capsules 100mg Twice Daily(BID) | 90.4 | Standard Deviation 42.9 | ng/ml | |
| Maximum Observed Plasma Concentration (Cmax) of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia on Day 1. | TNP-2092 Capsules 300mg BID | 140 | Standard Deviation 120 | ng/ml | |
| Maximum Observed Plasma Concentration (Cmax) of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia on Day 1. | TNP-2092 Capsules 600mg BID | 415 | Standard Deviation 294 | ng/ml | |
| Area Under the Plasma Concentration-time Curve From the Time of Administration to the Time of the Last Measurable Plasma Concentration (AUC0-last) on Day 1. | TNP-2092 Capsules 100mg Twice Daily(BID) | 309 | Standard Deviation 178 | h*ng/ml | |
| Area Under the Plasma Concentration-time Curve From the Time of Administration to the Time of the Last Measurable Plasma Concentration (AUC0-last) on Day 1. | TNP-2092 Capsules 300mg BID | 524 | Standard Deviation 537 | h*ng/ml | |
| Area Under the Plasma Concentration-time Curve From the Time of Administration to the Time of the Last Measurable Plasma Concentration (AUC0-last) on Day 1. | TNP-2092 Capsules 600mg BID | 1610 | Standard Deviation 1200 | h*ng/ml |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TNP-2092 Capsules 100mg Twice Daily(BID) | 8 | |
| Overall Study | STARTED | TNP-2092 Capsules 300mg BID | 8 | |
| Overall Study | STARTED | TNP-2092 Capsules 600mg BID | 8 | |
| Overall Study | STARTED | TNP-2092 Capsules Placebo | 12 | |
| Overall Study | COMPLETED | TNP-2092 Capsules 100mg Twice Daily(BID) | 7 | |
| Overall Study | COMPLETED | TNP-2092 Capsules 300mg BID | 8 | |
| Overall Study | COMPLETED | TNP-2092 Capsules 600mg BID | 8 | |
| Overall Study | COMPLETED | TNP-2092 Capsules Placebo | 11 | |
| Overall Study | NOT COMPLETED | TNP-2092 Capsules 100mg Twice Daily(BID) | 1 | |
| Overall Study | NOT COMPLETED | TNP-2092 Capsules 300mg BID | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events52
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 | neutrophil count decreased | Investigations | TNP-2092 Capsules 100mg Twice Daily(BID) | 2 | 8 | 4 |
| other | neutrophil count decreased | Investigations | TNP-2092 Capsules 300mg BID | 4 | 8 | 6 |
| other | neutrophil count decreased | Investigations | TNP-2092 Capsules 600mg BID | 6 | 8 | 7 |
| other | neutrophil count decreased | Investigations | Placebo | 6 | 12 | 7 |
| other | white blood cell count decreased | Investigations | TNP-2092 Capsules 100mg Twice Daily(BID) | 2 | 8 | 2 |
| other | white blood cell count decreased | Investigations | TNP-2092 Capsules 300mg BID | 2 | 8 | 3 |
| other | white blood cell count decreased | Investigations | TNP-2092 Capsules 600mg BID | 6 | 8 | 7 |
| other | white blood cell count decreased | Investigations | Placebo | 4 | 12 | 4 |
| other | Lymphocyte count decreased | Investigations | TNP-2092 Capsules 100mg Twice Daily(BID) | 1 | 8 | 1 |
| other | Lymphocyte count decreased | Investigations | TNP-2092 Capsules 300mg BID | 2 | 8 | 4 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TNP-2092 Capsules 100mg Twice Daily(BID) | 0 | 8 |
| Total, all-cause mortality | TNP-2092 Capsules 300mg BID | 0 | 8 |
| Total, all-cause mortality | TNP-2092 Capsules 600mg BID | 0 | 8 |
| Total, all-cause mortality | Placebo | 0 | 12 |
| Total, other adverse events | TNP-2092 Capsules 100mg Twice Daily(BID) | 6 | 8 |
| Total, other adverse events | TNP-2092 Capsules 300mg BID | 6 | 8 |
| Total, other adverse events | TNP-2092 Capsules 600mg BID | 7 | 8 |
| Total, other adverse events | Placebo | 8 | 12 |
| Total, serious adverse events | TNP-2092 Capsules 100mg Twice Daily(BID) | 0 | 8 |
| Total, serious adverse events | TNP-2092 Capsules 300mg BID | 0 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
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GET https://conductscience.org/api/trials/v1/NCT06135675/registered?page=2