BridgeMD
New treatment option for Acute Myeloid Leukemia With FLT3/ITD Mutation
Official title A Study to Evaluate the Effect of XY0206 on the QTc Interval in Chinese Healthy Participants
ClinicalTrials.gov ID: NCT07162116
What this study is testing
What is XY0206?
XY0206 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia with flt3/itd mutation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Participants can communicate well with the researchers and comply with the protocol requirements to complete the study.
You likely can't join if
- Medical history, past medical history, recent medication history:
- Those with a history of severe systemic diseases (including cardiovascular, digestive, urinary, respiratory systems, etc.), mental disorders, or drug...
- Those with a history of drug or food allergies, or specific allergies (such as asthma, urticaria, eczema, etc.); or those allergic to XY0206 tablets...
- 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...
- Those with a history of pancreatitis;
See the full eligibility criteria
Who can join
- 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...
- Participants can communicate well with the researchers and comply with the protocol requirements to complete the study.
What rules you out
- Medical history, past medical history, recent medication history:
- 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...
- 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;
- Those with a history of pancreatitis;
- Those who have undergone major surgery within 6 months before screening or whose surgical incisions have not fully healed; major surgeries include but are not limited to any surgeries with significant bleeding risks...
- Those who have donated blood within 3 months before screening, or plan to donate blood during this study, or have received blood transfusions or lost ≥200ml of blood within 4 weeks before screening;
- Those who have participated in 4 or more clinical trials within the past year; or those who have participated in any clinical trials and received investigational drugs or devices within 3 months before this trial;
- Those with a history of drug abuse within the past 5 years or have used drugs within 3 months before the trial;
- Those who have taken any prescription drugs, over-the-counter drugs, vitamin products, health supplements, or herbal medicines within 4 weeks before screening or within 5 half-lives (if known), whichever is longer; or...
- Those with a history of hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia;
- Those who have received vaccinations within 3 months before screening or plan to receive vaccinations during this study;
- Those with a history of fainting at the sight of blood or needles and cannot tolerate venous catheterization; Health status:
- Those with neurological, mental, respiratory, cardiovascular, digestive, hematological and lymphatic, endocrine, musculoskeletal, urinary, or any other diseases or physiological conditions that may affect the study...
- Those with a history of cardiovascular diseases or risk factors for torsades de pointes (TdP) at the time of screening, including but not limited to: unexplained syncope; heart failure; myocardial infarction; angina...
- Those with 12-lead electrocardiogram results exceeding the standard at the screening or baseline period: PR \> 200ms, QRS \> 110ms, HR \ 450 ms (for both males and females); or those with abnormal electrocardiograms and...
- Those with laboratory test results meeting the following abnormal ranges at the screening or baseline period: a. Abnormal hematological indicators: i. White blood cells \ upper limit of normal (ULN), total bilirubin...
- Participants with positive hepatitis B surface antigen and/or hepatitis B e antigen, positive hepatitis C antibody, positive human immunodeficiency virus antibody, or positive Treponema pallidum antibody during the...
- Participants with positive breath alcohol test or positive urine drug abuse screening at baseline; Lifestyle restrictions:
- Participants with special dietary requirements who cannot adhere to the diet and corresponding regulations provided by the clinical research institution;
- Participants who cannot control special diets (including pitaya, mango, grapefruit and/or xanthine diet, caffeine-containing foods or beverages, strong tea, etc.) during the trial;
- Participants who have consumed special diets (including pitaya, mango, grapefruit and/or xanthine diet, caffeine-containing foods or beverages, strong tea, etc.) or engaged in vigorous exercise within 48 hours before...
- Participants who have consumed alcohol frequently in the 6 months prior to administration, i.e., more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or...
- Participants who smoke more than 5 cigarettes per day in the 3 months prior to administration, or will use any tobacco products during the trial; Contraception:
- Pregnant or lactating women or those with positive pregnancy tests;
- Participants who have used oral contraceptives within 30 days before screening (applicable to females only);
- Participants who have used long-acting estrogen or progesterone injections or implants within 6 months before screening (applicable to females only);
- Females of childbearing age who have had unprotected sexual intercourse with their partners within 14 days before screening;
- Participants of childbearing age, male or female, who have a plan to conceive from the time of signing the informed consent form until one year after the end of the trial, or who do not agree to use effective...
- Participants who are considered to have poor compliance or have any other factors that make them unsuitable for this trial by the investigator;
- The investigator, their family members, and related personnel of the research center;
- Students and subordinates of the investigator, employees of the sponsor, and other vulnerable participants;
- Participants who may be unable to complete the study for other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Zibo, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zibo, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.