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.
Age range
18 Years – 45 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Maximum Plasma Concentration (Cmax) of Midazolam
Timeframe: Predose through 48 hours postdose on Days 1, 4, and 11
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Midazolam
Timeframe: Predose through 48 hours postdose on Days 1, 4, and 11
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Midazolam
Timeframe: Predose through 48 hours postdose on Days 1, 4, and 11