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

ConditionsHealthy Volunteers Drug-Drug Interaction (DDI)

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-45

SponsorThe Third Xiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male or female participants aged 18 to 45 years, inclusive.

Body mass index (BMI) from 19.0 to 26.0 kg/m², inclusive, with a body weight of at least 50 kg for males and at least 45 kg for females.

Participants who voluntarily sign the informed consent form before any study-related procedure and fully understand the study content, procedures, and potential adverse reactions.

Participants who are able to communicate effectively with the investigator and understand and comply with all study requirements.

Disqualifiers

Participation in any other drug clinical trial and receipt of an investigational medicinal product within 3 months before admission to the clinical research unit.

A history of chronic or active gastrointestinal disease within 3 years before admission, including esophageal disease, gastritis, gastric ulcer, gastroesophageal reflux disease, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery, that is considered clinically significant by the investigator.

A confirmed disease of the central nervous, cardiovascular, gastrointestinal, respiratory, endocrine, urinary, hematologic and lymphatic, or metabolic system requiring medical intervention, or any other condition, including a psychiatric history, that may make the participant unsuitable for the study.

A known or suspected history of immunodeficiency, such as frequent recurrent infections, or a history of hereditary or acquired complement deficiency.

Trial design

Design model

Crossover

Treatments tested in this trial

NTQ5082
Drug
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.
Midazolam
Drug
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.

Treatment groups

18 Participants

are divided into 1 treatment group

Group A: NTQ5082-Midazolam Drug-Drug Interaction ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Maximum Plasma Concentration (Cmax) of Midazolam

The maximum observed plasma concentration (Cmax) of midazolam will be determined from the plasma concentration-time data following a single oral dose of midazolam 2 mg administered alone on Day 1, coadministered with the first dose of NTQ5082 200 mg on Day 4, and coadministered with NTQ5082 200 mg after repeated NTQ5082 dosing on Day 11.

Time frame