NCT06551623

Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin

A Single Center, Open Label, Phase 1 Study in Healthy Participants to Investigate the Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: TenNor Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Midazolam cohort: Midazolam oral solution will be administered orally at a dose of 2 mg once a day within 0.5 hours after breakfast on Day 1, and administered following TNP-2198 capsules within 0.5 hours after breakfast on Day 10. TNP 2198 capsules will be administered orally at a dose of 400 mg twice a day, within 0.5 hours after breakfast and dinner, from Day 3 to Day 11. PK blood sampling and safety tests were performed at specified time points. Clarithromycin cohort: TNP-2198 capsules will be administered orally at a dose of 400 mg twice a day, within 0.5 hours after breakfast and dinner, from Day 1 to Day 7, and within 0.5 hours after breakfast on Day 8. Clarithromycin tablets will be administered at a dose of 0.5 g twice a day, within 0.5 hours after breakfast and dinner, from Day 16 to Day 25. TNP-2198 capsules will be administered within 0.5 hours after breakfast and dinner, followed by clarithromycin tablets, from Day 16 to Day 22. TNP-2198 capsules will be administrated within 0.5 hours after breakfast, followed by clarithromycin tablets on Day 23. PK blood sample collection and safety tests were performed at specified time points.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Midazolam	Midazolam Oral Solution 2 mg
DRUG	Clarithromycin	Clarithromycin tablets 0.5 g
DRUG	TNP-2198	TNP-2198 Capsules 400 mg

Timeline

• Start date: 2024-08-26
• Primary completion: 2024-10-14
• Completion: 2024-10-14
• First posted: 2024-08-13
• Last updated: 2024-10-24

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study