A Drug-Drug Interaction Study Between NTQ5082 Capsules and Midazolam Oral Solutio
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
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
Treatments tested in this trial
- NTQ5082
- Midazolam
Treatment groups
18 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
The Third Xiangya Hospital of Central South University
Lead sponsor
Nanjing Chia-tai Tianqing Pharmaceutical
Collaborator
Source ClinicalTrials.gov