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.
Inclusion Criteria:
Exclusion Criteria:
All enrolled healthy participants will follow the same open-label, fixed-sequence dosing regimen and will serve as their own controls. Participants will receive a single oral dose of midazolam oral solution 2 mg on Day 1; midazolam 2 mg coadministered with NTQ5082 200 mg on Day 4; NTQ5082 200 mg once daily from Day 4 through Day 12; and midazolam 2 mg coadministered with NTQ5082 200 mg on Day 11 following repeated NTQ5082 administration. Pharmacokinetic samples will be collected after midazolam dosing to evaluate the effects of single and repeated NTQ5082 administration on midazolam pharmacokinetics.
Drug-Drug Interaction Study to Evaluate the Pharmacokinetics and Safety of CTX 4430 and Midazolam
A Study to Investigate the Drug-drug Interactions (DDIs) Between SKLB1028 and Midazolam in Healthy Subjects