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

NCT07745439 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-08-04

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers
  • Drug-Drug Interaction (DDI)

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.

Sponsors & Collaborators

  • Nanjing Chia-tai Tianqing Pharmaceutical

    collaborator INDUSTRY

  • The Third Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2026-07-30
Completion
2027-07-31

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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 NCT07745439 on ClinicalTrials.gov