A Study to Evaluate the Effect of XY0206 on the QTc Interval in Chinese Healthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorShijiazhuang Yiling Pharmaceutical Co. Ltd
About this trial
This study plans to enroll 45 (Groups A, B, and C) to 75 healthy participants (including the sample size of other potential dose groups). The participants will be divided into three dose groups: 37.5 mg, 75 mg, and 150 mg. After taking the corresponding investigational product, participants are required to complete test procedures including QTc interval measurement , blood sampling, and vital sign monitoring. The entire test process lasts for 3 days. On the third day, after participants complete laboratory tests and are assessed by physicians as meeting the discharge criteria, they can be discharged.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants voluntarily sign a written informed consent form.
Male or female; aged between 18 and 45 years old (inclusive).
Male participants weigh ≥ 50kg, female participants weigh ≥ 45kg, and their body mass index (BMI) is between 19.0 and 26.0 kg/m², inclusive.
Physical examination, laboratory tests, and all trial-related examinations (vital signs, electrocardiogram, chest X-ray, abdominal color Doppler ultrasound, etc.) at the screening stage are normal or have only minor abnormalities without clinical significance, and are deemed qualified by the clinical research doctor.
Disqualifiers
Those with a history of severe systemic diseases (including cardiovascular, digestive, urinary, respiratory systems, etc.), mental disorders, or drug dependence;
Those with a history of drug or food allergies, or specific allergies (such as asthma, urticaria, eczema, etc.); or those allergic to XY0206 tablets, moxifloxacin hydrochloride, or other fluoroquinolones, or the excipients contained therein; or those known to be allergic to FLT3 inhibitors;
Those with a history of difficulty swallowing or any gastrointestinal diseases (or gastrointestinal resection, etc.) that affect drug absorption;
Those with hemorrhoids or perianal diseases with regular/ongoing bleeding, irritable bowel syndrome, inflammatory bowel disease; or those with habitual constipation or diarrhea;
Trial design
Design model
Factorial
Treatments tested in this trial
XY0206
Drug12.5 mg/table,On the morning of the day of dosing , subjects received XY0206 tablets orally on an empty stomach.Each group of 15 subjects was randomly assigned in a 3:1:1 ratio, with 9 receiving XY0206, 3 receiving a placebo of XY0206, and 3 receiving moxifloxacin.Group A (XY0206 tablets: 37.5 mg; moxifloxacin : 400 mg; placebo: 37.5 mg)；Group B(XY0206 tablets: 75 mg; moxifloxacin : 400 mg; placebo: 150mg)；Group C(XY0206 tablets:150 mg; moxifloxacin : 400 mg; placebo: 150mg)
Moxifloxacin (400 mg)
Drug400mg，On the morning of the day of dosing , subjects received moxifloxacin orally on an empty stomach
XY0206 Placebo
Other intervention12.5mg/table,On the morning of the day of dosing, subjects received XY0206 placebo orally on an empty stomach.Each group of 15 subjects was randomly assigned in a 3:1:1 ratio, with 9 receiving XY0206, 3 receiving a placebo of XY0206, and 3 receiving moxifloxacin.Group A (XY0206 tablets: 37.5 mg; moxifloxacin : 400 mg; placebo: 37.5 mg)；Group B(XY0206 tablets: 75 mg; moxifloxacin : 400 mg; placebo: 150mg)；Group C(XY0206 tablets:150 mg; moxifloxacin : 400 mg; placebo: 150mg)
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: XY0206Experimental treatment 1 intervention
Group B: MoxifloxacinActive comparator 1 intervention
Group C: XY0206 PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
QT/QTc
Holter ECG data of each study participant from 1 hour before administration to 48 hours after administration were collected, and data were extracted according to the collection point to evaluate the effect of a single dose of XY0206 tablets/placebo/moxifloxacin on the QT/QTc interval of healthy people
Time frame
48 hours after drug administrationSecondary outcomes
1
blood sample
Blood concentration is measured
Time frame
48 hours after drug administrationSponsors and contacts
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Source ClinicalTrials.gov