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

NCT06551623 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-10-24

No results posted yet for this study

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.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Midazolam

Midazolam Oral Solution 2 mg

DRUG

Clarithromycin

Clarithromycin tablets 0.5 g

DRUG

TNP-2198

TNP-2198 Capsules 400 mg

Sponsors & Collaborators

  • TenNor Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Xiaojiao Li · The First Hospital of Jilin University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2024-10-14
Completion
2024-10-14
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06551623 on ClinicalTrials.gov