Healthy VolunteersPhase 1NCT07745439
A Drug-Drug Interaction Study Between NTQ5082 Capsules and Midazolam Oral Solutio
A Phase 1 study testing NTQ5082 and Midazolam in people with Healthy Volunteers and Drug-Drug Interaction (DDI), run by The Third Xiangya Hospital of Central South University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Drug-Drug Interaction (DDI)
- What is being tested?
- NTQ5082 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
- A history of drug abuse or use of soft drugs, such as marijuana, or hard drugs, such as cocaine or phencyclidine, within 1 year before admission.
- Regular smoking or smoking more than 5 cigarettes per day within 3 months before admission, or inability to discontinue all tobacco products during the study.
- Alcohol abuse or regular alcohol consumption within 6 months before admission, defined as more than 14 units of alcohol per week, where 1 unit is equivalent to 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine, or unwillingness to abstain from alcohol and alcohol-containing products during the study.
- Consumption of excessive amounts of tea, coffee, or other caffeinated beverages, defined as more than 8 cups per day, with 1 cup equal to 250 mL, or unwillingness to discontinue such beverages during the study.
- Consumption within 7 days before admission of grapefruit, grapefruit-containing products, or other foods that may affect drug absorption, distribution, metabolism, or excretion, or unwillingness to avoid such foods during the study.
- Special dietary requirements or inability to comply with the standardized diet provided during the study.
- Female participants who are pregnant or breastfeeding; who have had unprotected sexual intercourse within 14 days before admission; who have used oral contraceptives within 30 days before admission; or who have used long-acting estrogen or progestogen injections or implants within 6 months before admission.
- Participants, or their partners, who plan pregnancy or sperm or oocyte donation from the time of signing informed consent through 3 months after the last dose, or who are unwilling to use at least one nonpharmacologic contraceptive method, such as complete abstinence, an intrauterine device, or partner sterilization.
- Clinically significant abnormalities, as determined by the investigator, in physical examination, electrocardiogram, abdominal ultrasound, chest radiograph, vital signs, or laboratory examinations, including hematology, urinalysis, blood chemistry, procalcitonin, coagulation, thyroid function, infectious disease screening, or serum pregnancy testing for females.
- A positive alcohol breath test or drug abuse screening result.
- Any other condition that, in the investigator's opinion, may prevent the participant from completing the study or otherwise make the participant unsuitable for participation.
About this study
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.
Read more
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.
Read the detailed description
This is a single-center, non-randomized, open-label, single-sequence, self-controlled drug-drug interaction study designed to evaluate the effect of single and multiple oral doses of NTQ5082 capsules on the pharmacokinetics of midazolam oral solution, a CYP3A probe substrate, in healthy participants. The study will also evaluate the safety and tolerability of the concomitant administration of NTQ5082 and midazolam.
Approximately 18 healthy male and female participants are planned to be enrolled. The study consists of a screening and protocol-required vaccination period from Day -28 to Day -1, an inpatient study period from Day 1 to Day 13, and a safety follow-up period within 7 days after discharge.
Participants will provide written informed consent between Day -28 and Day -14. After preliminary screening, eligible participants will receive the protocol-required vaccination between Day -28 and Day -14. Additional screening assessments and confirmation of eligibility will be conducted between Day -7 and Day -1. Screening assessments will include demographic information, medical history, medication history, previous clinical trial participation, vital signs, physical examination, electrocardiography, and laboratory tests.
Eligible participants will be admitted to the clinical research center on Day -1 and will remain in the center through Day 12. A discharge assessment will be performed on Day 13 or at the time of early withdrawal.
Participants will receive midazolam oral solution 2 mg (1 mL) as a single oral dose under fasting conditions on Days 1, 4, and 11. Participants will also receive NTQ5082 capsules 200 mg, administered as two 100 mg capsules, once daily under fasting conditions from Day 4 through Day 12.
The Day 1 administration of midazolam will be used to characterize the pharmacokinetics of midazolam when administered alone. On Day 4, midazolam will be coadministered with the first dose of NTQ5082 to evaluate the effect of a single dose of NTQ5082. On Day 11, midazolam will be coadministered with NTQ5082 after repeated daily dosing to evaluate the effect of multiple doses of NTQ5082.
On Days 1, 4, and 11, participants will fast for at least 10 hours before dosing. Midazolam oral solution must be completely swallowed. The dosing container will be rinsed with drinking water, and the rinse water will also be consumed. NTQ5082 capsules must be swallowed whole and must not be chewed, crushed, opened, or divided. When midazolam and NTQ5082 are administered together, the total amount of water used for dosing will be approximately 240 mL.
Except for water required for study drug administration, participants will not be permitted to drink water from 1 hour before dosing until 1 hour after dosing. On Days 1, 4, and 11, participants will not receive food for at least 4 hours after dosing. On other NTQ5082 dosing days, food will be restricted for 1 hour before and 1 hour after dosing. Study treatment will be administered at approximately the same time each day under the supervision of study personnel.
For pharmacokinetic evaluation, blood samples will be collected on Days 1, 4, and 11 at predose and at 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, and 48 hours after midazolam administration. Plasma concentrations of midazolam and its metabolite, 1'-hydroxymidazolam, will be measured.
The primary pharmacokinetic parameters include maximum observed plasma concentration (Cmax), area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t), and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf). Other pharmacokinetic parameters may include Tmax, terminal elimination rate constant, terminal elimination half-life, apparent volume of distribution, apparent clearance, and mean residence time.
Safety will be assessed throughout the study by monitoring adverse events, concomitant medications, vital signs, physical examinations, 12-lead electrocardiograms, and clinical laboratory tests. Laboratory assessments may include hematology, urinalysis, blood chemistry, coagulation tests, procalcitonin, and thyroid function tests.
Participants will undergo an end-of-study safety assessment on Day 13 or at early withdrawal. A telephone safety follow-up will be conducted within 7 days after discharge or early withdrawal. Any ongoing adverse event will be followed until it has resolved, improved, returned to baseline, become clinically stable, been explained by another cause, or the participant is lost to follow-up.
- Conditions
- Healthy Volunteers, Drug-Drug Interaction (DDI)
- Being tested
- NTQ5082, Midazolam
- Keywords
- NTQ5082, Midazolam, CYP3A, Drug-Drug Interaction, Pharmacokinetics, Pharmacokinetic Interaction, Complement Factor B Inhibitor, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTQ5082Drug
Also called NTQ5082 Capsules
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.
MidazolamDrug
Also called Midazolam Oral Solution
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: NTQ5082; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Predose through 48 hours postdose on Days 1, 4, and 11
Secondary outcomes (4)
Time to Maximum Plasma Concentration (Tmax) of Midazolam
The time to reach the maximum observed plasma concentration of midazolam will be determined following midazolam administration on Days 1, 4, and 11.
Measured: Predose through 48 hours postdose on Days 1, 4, and 11
Terminal Elimination Half-Life (t1/2z) of Midazolam
The terminal elimination half-life of midazolam will be estimated using the terminal log-linear phase of the plasma concentration-time profile.
Measured: Predose through 48 hours postdose on Days 1, 4, and 11
Apparent Oral Clearance (CLz/F) of Midazolam
The apparent oral clearance of midazolam will be calculated following midazolam administration alone and during coadministration with NTQ5082.
Measured: Predose through 48 hours postdose on Days 1, 4, and 11
Number of Participants With Treatment-Emergent Adverse Events
Safety will be assessed based on treatment-emergent adverse events, clinical laboratory tests, vital signs, physical examinations, and electrocardiograms. Adverse events will be assessed for severity, seriousness, outcome, and relationship to the study intervention.
Measured: From the first dose on Day 1 through the safety follow-up conducted within 7 days after discharge, approximately through Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Chia-tai Tianqing Pharmaceutical
- Responsible party
- Principal investigator, Guoping Yang, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745439
- Sponsor's protocol ID
- NTQ5082-107
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Drug-Drug Interaction Study Between NTQ5082 Capsules and Midazolam Oral Solutio
- ClinicalTrials.gov ID
- NCT07745439
- Acronym / sponsor ID
- NTQ5082-107
- Conditions
- Healthy Volunteers, Drug-Drug Interaction (DDI)
- Keywords
- NTQ5082, Midazolam, CYP3A, Drug-Drug Interaction, Pharmacokinetics, Pharmacokinetic Interaction, Complement Factor B Inhibitor, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Nanjing Chia-tai Tianqing Pharmaceutical
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, non-randomized, open-label, single-sequence, self-controlled drug-drug interaction study designed to evaluate the effect of single and multiple oral doses of NTQ5082 capsules on the pharmacokinetics of midazolam oral solution, a CYP3A probe substrate, in healthy participants. The study will also evaluate the safety and tolerability of the concomitant administration of NTQ5082 and midazolam.
Approximately 18 healthy male and female participants are planned to be enrolled. The study consists of a screening and protocol-required vaccination period from Day -28 to Day -1, an inpatient study period from Day 1 to Day 13, and a safety follow-up period within 7 days after discharge.
Participants will provide written informed consent between Day -28 and Day -14. After preliminary screening, eligible participants will receive the protocol-required vaccination between Day -28 and Day -14. Additional screening assessments and confirmation of eligibility will be conducted between Day -7 and Day -1. Screening assessments will include demographic information, medical history, medication history, previous clinical trial participation, vital signs, physical examination, electrocardiography, and laboratory tests.
Eligible participants will be admitted to the clinical research center on Day -1 and will remain in the center through Day 12. A discharge assessment will be performed on Day 13 or at the time of early withdrawal.
Participants will receive midazolam oral solution 2 mg (1 mL) as a single oral dose under fasting conditions on Days 1, 4, and 11. Participants will also receive NTQ5082 capsules 200 mg, administered as two 100 mg capsules, once daily under fasting conditions from Day 4 through Day 12.
The Day 1 administration of midazolam will be used to characterize the pharmacokinetics of midazolam when administered alone. On Day 4, midazolam will be coadministered with the first dose of NTQ5082 to evaluate the effect of a single dose of NTQ5082. On Day 11, midazolam will be coadministered with NTQ5082 after repeated daily dosing to evaluate the effect of multiple doses of NTQ5082.
On Days 1, 4, and 11, participants will fast for at least 10 hours before dosing. Midazolam oral solution must be completely swallowed. The dosing container will be rinsed with drinking water, and the rinse water will also be consumed. NTQ5082 capsules must be swallowed whole and must not be chewed, crushed, opened, or divided. When midazolam and NTQ5082 are administered together, the total amount of water used for dosing will be approximately 240 mL.
Except for water required for study drug administration, participants will not be permitted to drink water from 1 hour before dosing until 1 hour after dosing. On Days 1, 4, and 11, participants will not receive food for at least 4 hours after dosing. On other NTQ5082 dosing days, food will be restricted for 1 hour before and 1 hour after dosing. Study treatment will be administered at approximately the same time each day under the supervision of study personnel.
For pharmacokinetic evaluation, blood samples will be collected on Days 1, 4, and 11 at predose and at 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, and 48 hours after midazolam administration. Plasma concentrations of midazolam and its metabolite, 1'-hydroxymidazolam, will be measured.
The primary pharmacokinetic parameters include maximum observed plasma concentration (Cmax), area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t), and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf). Other pharmacokinetic parameters may include Tmax, terminal elimination rate constant, terminal elimination half-life, apparent volume of distribution, apparent clearance, and mean residence time.
Safety will be assessed throughout the study by monitoring adverse events, concomitant medications, vital signs, physical examinations, 12-lead electrocardiograms, and clinical laboratory tests. Laboratory assessments may include hematology, urinalysis, blood chemistry, coagulation tests, procalcitonin, and thyroid function tests.
Participants will undergo an end-of-study safety assessment on Day 13 or at early withdrawal. A telephone safety follow-up will be conducted within 7 days after discharge or early withdrawal. Any ongoing adverse event will be followed until it has resolved, improved, returned to baseline, become clinically stable, been explained by another cause, or the participant is lost to follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NTQ5082-Midazolam Drug-Drug Interaction Arm | Experimental | Drug: NTQ5082, Drug: MidazolamAll 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTQ5082Also: NTQ5082 CapsulesNTQ5082 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 | NTQ5082-Midazolam Drug-Drug Interaction Arm |
| MidazolamAlso: Midazolam Oral SolutionA 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. | Drug | NTQ5082-Midazolam Drug-Drug Interaction Arm |
Primary outcome
Maximum Plasma Concentration (Cmax) of Midazolam
Time frame: Predose through 48 hours postdose on Days 1, 4, and 11
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.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Midazolam
Time frame: Predose through 48 hours postdose on Days 1, 4, and 11
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.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Midazolam
Time frame: Predose through 48 hours postdose on Days 1, 4, and 11
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.
4 secondary outcomes
Time to Maximum Plasma Concentration (Tmax) of Midazolam
Time frame: Predose through 48 hours postdose on Days 1, 4, and 11
Terminal Elimination Half-Life (t1/2z) of Midazolam
Time frame: Predose through 48 hours postdose on Days 1, 4, and 11
Apparent Oral Clearance (CLz/F) of Midazolam
Time frame: Predose through 48 hours postdose on Days 1, 4, and 11
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From the first dose on Day 1 through the safety follow-up conducted within 7 days after discharge, approximately through Day 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NTQ5082 and Midazolam in people with Healthy Volunteers and Drug-Drug Interaction (DDI), run by The Third Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of Midazolam (time frame: Predose through 48 hours postdose on Days 1, 4, and 11). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.