Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin
NCT Number: NCT06551623
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Helicobacter Pylori Infection
Interventions: DRUG: Midazolam|DRUG: Clarithromycin|DRUG: TNP-2198|DRUG: TNP-2198
Sponsor: TenNor Therapeutics Inc.
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-26
Completion Date: 2024-10
Locations: The First Hospital of Jinlin University, Changchun, Jilin, China

Summary:
This is a single center, open label, drug-drug interaction, Phase 1 study of TNP-2198 in approximately 32 healthy participants, includes 2 cohorts (16 participants per cohort): Midazolam cohort and Clarithromycin cohort. Midazolam cohort will evaluate the effect of multiple oral doses of TNP-2198 capsules on the pharmacokinetics (PK) parameters of a single oral dose of midazolam, a cytochrome P-450 (CYP) 3A sensitive substrate, in healthy participants; Clarithromycin cohort will evaluate the effect of multiple oral doses of clarithromycin tablets, a strong CYP3A and P-gp inhibitor, on the PK parameters of multiple oral doses of TNP-2198 in healthy participants.

Primary Outcome Measures: Midazolam cohort: PK parameters of midazolam-Area under the plasma concentration versus time curve (AUC0-t), Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration (AUC0-t), Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.|Midazolam cohort: PK parameters of midazolam-Area under the plasma concentration versus time curve (AUC0-∞), Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-∞), Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.|Midazolam cohort: PK parameters of midazolam-Maximum observed plasma concentration (Cmax), Maximum observed plasma concentration (Cmax), Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.|Clarithromycin cohort: PK parameters of TNP-2198-Area under the plasma concentration versus time curve(AUC0-t), Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration, Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.|Clarithromycin cohort: PK parameters of TNP-2198-Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-∞), Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.|Clarithromycin cohort: PK parameters of TNP-2198-Maximum observed plasma concentration (Cmax), Cmax, Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.
Secondary Outcome Measures: Midazolam cohort: Percentage of Participants With Adverse Events (AEs), An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events, Day 1 to Day 12|Clarithromycin cohort:Percentage of Participants With Adverse Events (AEs), An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events, Day 1 to Day 26