A Phase 1 Study to Evaluate PK Profile and Food Effects on PK Parameters of TNP-2092 Capsules

NCT06178718 | Completed Phase 1 Results

• 1 other identifier: TNP-2092-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperammonemia

Outcome Measures

Primary Outcomes (11)

• 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

• 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

Study Arms (2)

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.

Drug: TNP-2092 capsules

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.

Drug: TNP-2092 placebo capsules

Interventions

TNP-2092 capsules DRUG

Administered orally, 100 to 1200 mg

Also known as: Rifaquizinone

TNP-2092 capsules

TNP-2092 placebo capsules DRUG

Administered orally

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sex: male or female;
• Age: 18-45 years, inclusive;
• BMI: 19.0-26.0 kg/m2, inclusive;
• Female subjects of childbearing potential must agree to practice abstinence or take effective contraceptive measures during the study and at least 70 days (10 weeks) after administration;
• Male subjects must agree to practice abstinence or use condoms as a contraceptive measure during the study and at least 70 days (10 weeks) after administration;
• Subjects whose clinical laboratory test results are within the normal range or whose test results are abnormal, but judged by the investigator to be of no clinical insignificance;
• Those who do not smoke, or have smoked less than 5 cigarettes per day within 3 months before screening; those who do not drink alcohol, or have drunk less than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) within 6 months before screening; those who have not smoked or drunk alcohol within 48 hours before admission to the study site;
• Those who are fully informed of and understand this study, and have signed the Informed Consent Form;
• Those who are willing to follow and able to complete all the study procedures.

You may not qualify if:

• Those with symptoms or medical history of cardiovascular, digestive, respiratory, urinary, neurological, blood, immune, endocrine system diseases or tumor, mental illness, or any situation which, in the opinion of the investigator, may threaten the safety of the subjects or affect the correctness of the study results;
• Pregnant or lactating women;
• Those whose blood pressure above 150/90 mmHg or below 85/55 mmHg (supine position);
• Those with regular use of any prescription/over-the-counter drugs, including vitamins, minerals, nutritional supplements or herbs, within 2 weeks before enrollment and during the study;
• Those who are HIV positive, syphilis positive, hepatitis B surface antigen positive, hepatitis C antibody positive, and/or with a positive drug urine test result;
• Those who have a history of alcohol or drug abuse in the past 10 years; Those with an allergic constitution, a history of allergic diseases or a history of drug allergy;
• Those who have had beverages or foods containing methylxanthine (coffee, tea, coke, chocolate and energy drinks), grapefruit (fruit juice) and alcohol within 48 hours (2 days) before the clinical study;
• Those who have taken any drug that changes the activity of liver enzymes within 28 days before taking the investigational product or during the study;
• Those who have donated blood within 3 months before enrollment;
• Those who have participated in any clinical studies within 3 months before enrollment;
• Those who are the staff of the study site directly affiliated to this study or are their immediate family members. Immediate family members are defined as spouses, parents, children or siblings, whether related by blood or legally adopted;
• Those who are employees of TenNor Therapeutics;
• Other circumstances deemed by the investigator to be unsuitable for the subject to participate in this study.

Sponsors & Collaborators

• TenNor Therapeutics (Suzhou) Limited: lead
• The First Hospital of Jilin University: collaborator

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Hyperammonemia

Interventions

TNP-2092

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: TenNor
• Organization: TenNor Therapeutics (Suzhou) Limited.

info@tennorx.com

0512-86861990

Study Officials

• Yanhua Ding, MD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 21, 2023
• Study Start: June 6, 2016
• Primary Completion: August 2, 2016
• Study Completion: August 2, 2016
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)