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| Name | Class |
|---|---|
| The First Hospital of Jilin University | OTHER |
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The aim of the study was to evaluate the tolerability and pharmacokinetic characteristics of TNP-2092 Capsules after single-dose administration in healthy subjects, and the food effect on pharmacokinetics.
This was a single-center, randomized, double-blind, placebo-controlled, dose-ascending single-dose-administration study, and a study on the food effects on pharmacokinetics. Five dose groups of 100 mg, 200 mg, 400 mg, 800 mg, and 1200 mg will be set up.
The 100 mg, 200 mg, 800 mg, and 1200 mg groups will complete the single ascending dose study, with 10 subjects randomized in each group, 8 subjects receiving TNP-2092 and 2 receiving placebo. The drug will be administered once in each group in the fasting state, and tolerability will be evaluated on D4. Subjects were sequentially enrolled into different dose groups in ascending order of dose, and only when the previous lower dose was confirmed to be safe and well tolerated could they be enrolled into the next higher dose group.
The 400 mg group will complete the single ascending dose study, food effect study and undergo the metabolic transformation evaluation. A total of 18 subjects will be enrolled in the group and randomized into Group A and Group B, with 8 subjects receiving the investigational product and 1 receiving placebo. The drugs will be administered in the fasting state and in the fed state for two cycles, with a wash-out period of 4 days. In terms of the administration sequence, Group A will first take TNP-2092 Capsules or placebo in the fasting state, and then TNP-2092 Capsules or placebo in the fed state; Group B will first take TNP-2092 Capsules or placebo in the fed state, and then TNP-2092 Capsules or placebo in the fasting state. Tolerability evaluation will be conducted on D4 and at the end of the study of food effects on pharmacokinetics (D8).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNP-2092 capsules | Experimental | In single ascending dose study, participants received single oral dose of TNP-2092 capsules 100 to 1200 mg in fasted state. In food effect study, participants received single oral dose of TNP-2092 capsules 400 mg in fasted or fed state in a two-sequence, two-period crossover design. |
|
| Placebo | Placebo Comparator | In single ascending dose study, participants received single oral dose of TNP-2092 placebo capsules in fasted state. In food effect study, participants received single oral dose of TNP-2092 placebo capsules in fasted or fed state in a two-sequence, two-period crossover design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNP-2092 capsules | Drug | Administered orally, 100 to 1200 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of TNP-2092 by Assessment of the Number of Participants With Adverse Events (AEs) | To investigate the safety and tolerability of TNP-2092 by assessment of the number of participants with AEs. 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. | Up to 8 days after the first dosing. |
| Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) in Single Ascending Dose Study | Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
| Area Under the Plasma Concentration Versus Time Curve From 0 to the Last Measurable Concentration (AUC0-last) in Single Ascending Dose Study | 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. | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
| Maximum Observed Plasma Concentration (Cmax) of TNP-2092 in Single Ascending Dose Study | 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. | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding, MD | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | TNP-2092 Capsules 100mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 100mg on Day 1 in fasting state. |
| FG001 | TNP-2092 Capsules 200mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 200mg on Day 1 in fasting state. |
| FG002 | TNP-2092 Capsules 400mg - Group A (Fasting - Fed) | Participants in TNP-2092 capsules 400mg Group A completed single ascending dose study and food effect study. Participants received oral dose of TNP-2092 capsules 400mg on Day 1 in fasting state, and in fed state on Day 5 with a 4-day wash-out period. |
| FG003 | TNP-2092 Capsules 800mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 800mg on Day 1 in fasting state. |
| FG004 | TNP-2092 Capsules 1200mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 1200mg on Day 1 in fasting state. |
| FG005 | Placebo (Fasting) | Participants received TNP-2092 placebo capsules on Day 1 in fasting state, including 2 participants each in 100, 200, 800 and 1200 mg dose group. |
| FG006 | TNP-2092 Capsules 400mg - Group B (Fed -Fasting) | Participants received single oral dose of TNP-2092 capsules 400mg on Day 1 in fed state, and in fasting state on Day 5 with a 4-day wash-out period. |
| FG007 | Placebo (Fed-fasting) | One participant in 400 mg group B received TNP-2092 placebo capsules on Day 1 in fed state, and in fasting state on Day 5 with a 4-day wash-out period. |
| FG008 | Placebo (Fasting-fed) | One participant in 400 mg group A received TNP-2092 placebo capsules on Day 1 in fasting state, and in fed state on Day 5 with a 4-day wash-out period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TNP-2092 Capsules 100mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 100mg on Day 1 in fasting state. |
| BG001 | TNP-2092 Capsules 200mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 200mg on Day 1 in fasting state. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety of TNP-2092 by Assessment of the Number of Participants With Adverse Events (AEs) | To investigate the safety and tolerability of TNP-2092 by assessment of the number of participants with AEs. 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. | All subjects who have received at least one dose of study drug. | Posted | Count of Participants | Participants | Up to 8 days after the first dosing. |
|
Up to 8 days after the first dosing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TNP-2092 Capsules 100mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 100mg on Day 1 in fasting state. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Activated partial thromboplastin time prolonged | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| TenNor | TenNor Therapeutics (Suzhou) Limited. | 0512-86861990 | info@tennorx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2016 | Dec 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D022124 | Hyperammonemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000619733 | TNP-2092 |
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| TNP-2092 placebo capsules | Drug | Administered orally |
|
|
| Time to Maximum Plasma Concentration (Tmax) of TNP-2092 in Single Ascending Dose Study | 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. | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
| Terminal Elimination Half-life (T1/2) in Single Ascending Dose Study | 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. | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
| Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) in Food Effect Study | 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. | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
| Area Under the Plasma Concentration Versus Time Curve From 0 to the Last Measurable Concentration (AUC0-last) in Food Effect Study | 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. | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
| Maximum Observed Plasma Concentration (Cmax) of TNP-2092 in Food Effect Study | 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. | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
| Time to Maximum Plasma Concentration (Tmax) of TNP-2092 in Food Effect Study | 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. | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
| Terminal Elimination Half-life (T1/2) in Food Effect Study | 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. | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
| BG002 | TNP-2092 Capsules 400mg - Group A (Fasting-fed) | Participants in TNP-2092 capsules 400mg Group A completed single ascending dose study and food effect study. Participants received oral dose of TNP-2092 capsules 400mg on Day 1 in fasting state, and in fed state on Day 5 with a 4-day wash-out period. |
| BG003 | TNP-2092 Capsules 800mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 800mg on Day 1 in fasting state. |
| BG004 | TNP-2092 Capsules 1200mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 1200mg on Day 1 in fasting state. |
| BG005 | Placebo (Fasting) | Participants received TNP-2092 placebo capsules on Day 1 in fasting state, including 2 participants each in 100, 200, 800, 1200 mg dose group, and 1 participant in 400 mg group A. |
| BG006 | TNP-2092 Capsules 400mg - Group B (Fed -Fasting) | Participants received single oral dose of TNP-2092 capsules 400mg on Day 1 in fed state, and in fasting state on Day 5 with a 4-day wash-out period. |
| BG007 | Placebo (Fed-fasting) | Participants received placebo on Day 1 in fed state, and in fasting state on Day 5 with a 4-day wash-out period, including one participant in 400 mg group B. |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received single oral dose of TNP-2092 capsules 200mg on Day 1 in fasting state. |
| OG002 | TNP-2092 Capsules 400mg (Fasting ) | Participants received oral dose of TNP-2092 capsules 400mg in fasting state. |
| OG003 | TNP-2092 Capsules 800mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 800mg on Day 1 in fasting state. |
| OG004 | TNP-2092 Capsules 1200mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 1200mg on Day 1 in fasting state. |
| OG005 | Placebo (Fasting) | Participants received TNP-2092 placebo capsules in fasting state. |
| OG006 | TNP-2092 Capsules 400mg - (Fed) | Participants received oral dose of TNP-2092 capsules 400mg in fed state. |
| OG007 | Placebo (Fed) | Participants received placebo in fed state, with 1 participant in each of the 400 mg groups A and B. |
|
|
| Primary | Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) in Single Ascending Dose Study | Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | 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. | Posted | Mean | Standard Deviation | h*µg/L | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
|
|
|
| Primary | Area Under the Plasma Concentration Versus Time Curve From 0 to the Last Measurable Concentration (AUC0-last) in Single Ascending Dose Study | 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. | 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. | Posted | Mean | Standard Deviation | h*µg/L | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
|
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| Primary | Maximum Observed Plasma Concentration (Cmax) of TNP-2092 in Single Ascending Dose Study | 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. | 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. | Posted | Mean | Standard Deviation | µg/L | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
|
|
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| Primary | Time to Maximum Plasma Concentration (Tmax) of TNP-2092 in Single Ascending Dose Study | 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. | 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. | Posted | Mean | Standard Deviation | h | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
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| Primary | Terminal Elimination Half-life (T1/2) in Single Ascending Dose Study | 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. | Posted | Mean | Standard Deviation | h | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
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|
|
| Primary | Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) in Food Effect Study | 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. | 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. | Posted | Mean | Standard Deviation | h*µg/L | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
|
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| Primary | Area Under the Plasma Concentration Versus Time Curve From 0 to the Last Measurable Concentration (AUC0-last) in Food Effect Study | 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. | 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. | Posted | Mean | Standard Deviation | h*µg/L | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of TNP-2092 in Food Effect Study | 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. | 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. | Posted | Mean | Standard Deviation | µg/L | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
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| Primary | Time to Maximum Plasma Concentration (Tmax) of TNP-2092 in Food Effect Study | 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. | 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. | Posted | Mean | Standard Deviation | h | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
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| Primary | Terminal Elimination Half-life (T1/2) in Food Effect Study | 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. | 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. | Posted | Mean | Standard Deviation | h | Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | TNP-2092 Capsules 200mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 200mg on Day 1 in fasting state. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG002 | TNP-2092 Capsules 400mg (Fasting ) | Participants received oral dose of TNP-2092 capsules 400mg in fasting state. | 0 | 16 | 0 | 16 | 2 | 16 |
| EG003 | TNP-2092 Capsules 800mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 800mg on Day 1 in fasting state. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG004 | TNP-2092 Capsules 1200mg (Fasting) | Participants received single oral dose of TNP-2092 capsules 1200mg on Day 1 in fasting state. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG005 | Placebo (Fasting) | Participants received TNP-2092 placebo capsules in fasting state. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG006 | TNP-2092 Capsules 400mg - (Fed) | Participants received oral dose of TNP-2092 capsules 400mg in fed state. | 0 | 16 | 0 | 16 | 2 | 16 |
| EG007 | Placebo (Fed) | Participants received placebo in fed state, with 1 participant in each of the 400 mg groups A and B. | 0 | 2 | 0 | 2 | 0 | 2 |
| Blood glucose increased | Investigations | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Blood bilirubin unconjugated increased | Investigations | Systematic Assessment |
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| Acarodermatitis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
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