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NOT YET RECRUITING
NCT07745439
PHASE1

A Drug-Drug Interaction Study Between NTQ5082 Capsules and Midazolam Oral Solutio

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

This is a single-center, non-randomized, open-label, single-sequence, self-controlled drug-drug interaction study in healthy participants. The main purpose of the study is to evaluate whether a single dose and repeated daily doses of NTQ5082 capsules affect the pharmacokinetics of midazolam oral solution. Midazolam is used in this study as a probe drug to assess the activity of cytochrome P450 3A (CYP3A), an enzyme involved in the metabolism of many medicines. Approximately 18 healthy male and female participants will be enrolled. Participants will receive a single oral dose of midazolam 2 mg on Days 1, 4, and 11. NTQ5082 200 mg will be administered orally once daily from Day 4 through Day 12. Blood samples will be collected to measure the concentrations of midazolam and its metabolite, 1'-hydroxymidazolam, and to calculate pharmacokinetic parameters. The safety and tolerability of midazolam administered alone and together with NTQ5082 will also be evaluated through adverse event monitoring, laboratory tests, vital signs, physical examinations, and electrocardiograms. The study includes a screening and protocol-required vaccination period, an inpatient treatment period, and a safety follow-up telephone call within 7 days after discharge.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-07-30

Completion Date

2027-07-31

Last Updated

2026-08-04

Healthy Volunteers

Yes

Interventions

DRUG

NTQ5082

NTQ5082 will be administered orally at a dose of 200 mg, provided as two 100-mg capsules, once daily from Day 4 through Day 12 under fasting conditions. On Days 4 and 11, NTQ5082 will be coadministered with a single 2-mg dose of midazolam oral solution. On Days 5 through 10 and Day 12, NTQ5082 will be administered alone. The capsules must be swallowed whole with approximately 240 mL of water.

DRUG

Midazolam

A single oral dose of midazolam 2 mg, administered as 1 mL of oral solution, will be given under fasting conditions on Days 1, 4, and 11. Midazolam will be administered alone on Day 1, coadministered with the first dose of NTQ5082 on Day 4, and coadministered with NTQ5082 following repeated NTQ5082 dosing on Day 11. Approximately 240 mL of water, including water used to rinse the dosing container, will be used for administration.