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

NCT07745439 | Not Yet Recruiting Phase 1

• 1 other identifier: NTQ5082-107
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

NTQ5082; Midazolam; CYP3A; Drug-Drug Interaction; Pharmacokinetics; Pharmacokinetic Interaction; Complement Factor B Inhibitor; Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  The area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of midazolam will be calculated after midazolam administration alone on Day 1, with the first dose of NTQ5082 on Day 4, and after repeated NTQ5082 dosing on Day 11.

  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

  The area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of midazolam will be calculated after midazolam administration alone on Day 1, with the first dose of NTQ5082 on Day 4, and after repeated NTQ5082 dosing on Day 11.

  Predose through 48 hours postdose on Days 1, 4, and 11

Secondary Outcomes (4)

• Time to Maximum Plasma Concentration (Tmax) of Midazolam

  Predose through 48 hours postdose on Days 1, 4, and 11

• Terminal Elimination Half-Life (t1/2z) of Midazolam

  Predose through 48 hours postdose on Days 1, 4, and 11

• Apparent Oral Clearance (CLz/F) of Midazolam

  Predose through 48 hours postdose on Days 1, 4, and 11

• Number of Participants With Treatment-Emergent Adverse Events

  From the first dose on Day 1 through the safety follow-up conducted within 7 days after discharge, approximately through Day 20

Study Arms (1)

NTQ5082-Midazolam Drug-Drug Interaction Arm

EXPERIMENTAL

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: NTQ5082; Drug: Midazolam

Interventions

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.

Also known as: Midazolam Oral Solution

NTQ5082-Midazolam Drug-Drug Interaction Arm

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.

Also known as: NTQ5082 Capsules

NTQ5082-Midazolam Drug-Drug Interaction Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Participants who are willing to receive an ACYW135 meningococcal vaccine and a pneumococcal vaccine at least 14 days before the first dose. Repeat vaccination is not required if the participant received a pneumococcal vaccine within 5 years before dosing or an ACYW135 meningococcal vaccine within 3 years before dosing.

You may not qualify if:

• 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.
• A confirmed history of infection caused by encapsulated microorganisms within 6 months before admission, including but not limited to Streptococcus pneumoniae, Bacillus anthracis, Salmonella species, Salmonella Typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae, or Legionella pneumophila.
• A history of tuberculosis infection or current tuberculosis infection.
• An active systemic bacterial, viral, or fungal infection within 14 days before the first dose.
• Symptoms such as dizziness, headache, abdominal pain, diarrhea, or constipation within 14 days before the first dose that, in the investigator's opinion, make the participant unsuitable for the study.
• Known hypersensitivity to either study intervention, any of their components, or related preparations, or a history of allergy to drugs, food, or other substances.
• Inability to tolerate venipuncture or a history of fainting in response to blood or needles.
• Surgery within 6 months before admission that, in the investigator's opinion, may affect drug absorption, distribution, metabolism, or excretion; any surgical procedure within 30 days before admission; or planned surgery during the study.
• Use of any medication within 28 days before admission, including prescription drugs, nonprescription drugs, traditional Chinese medicines, Chinese patent medicines, or dietary supplements, or use within 5 half-lives of the medication at screening, whichever period is longer.
• Receipt of any vaccine, including a live attenuated vaccine, within 14 days before the first dose, except for the meningococcal and pneumococcal vaccines required by the protocol, or planned vaccination during the study.
• Corrected QT interval (QTc) of at least 450 milliseconds for males or at least 460 milliseconds for females at screening.
• Blood donation or significant blood loss of more than 400 mL, blood transfusion, or receipt of blood products within 3 months before admission, or an intention to donate blood or blood components during the study or within 3 months after study completion.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• Nanjing Chia-tai Tianqing Pharmaceutical: collaborator

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pharmacology

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: July 30, 2026
• Primary Completion: July 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07