NL-OMON53588尚未招募2 期
A Phase II, Double-Blind 2-arm study to investigate the effect on ventricular ectopy, safety, tolerability and pharmacokinetics of S48168 (ARM210) compared with Placebo in adults with Type 1 Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT1) - The effect of S48168 (ARM210) in adults with CPVT1
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Participants are eligible to be included in the study only if all the following
- •criteria apply: Age 1. Participant must be at least 18 years of age inclusive,
- •at the time of signing the informed consent Type of Participant and Disease
- •Characteristics 2. Participants who are willing and able to comply with
- •scheduled visits, study drug administration plan, study restrictions, and study
- •procedures. 3. Participants have a confirmed genetic diagnosis of CPVT1 and
- •supporting clinical phenotype, including residual ventricular ectopy (a
- •complexity score >=2; requiring at minimum the presence of PVCs in bigeminy on
- •exercise stress test) on a stable (at least 1 month) standard-of-care,
- •CPVT1-directed treatment regimen as decided by their CPVT treating physician.
- •Weight 4. Have a body mass index (BMI) <= 38 kg/m2 (inclusive) at screening. Sex
- •and Contraceptive/Barrier Requirements 5. Male participants agree to not donate
- •sperm from the first day of dosing of study drug until 5 half-lives plus 90
- •days (approximately 94 days) after the last dose of study drug. Female
- •participants: eligible to participate if she is not pregnant or breastfeeding,
- •and uses one of the following highly effective birth control methods (from the
- •first dose until 5 half-lives plus 90 days (approximately 94 days): •
- •Prescribed hormonal oral contraceptives, vaginal ring, or transdermal patch. •
- •Intrauterine device (IUD). • Intrauterine hormone-releasing system (IUS). •
- •Depot/implantable hormone (e.g., Depo-Provera®, Implanon). • Bilateral tubal
- •occlusion/ligation. • Sexual abstinence. • Refraining from heterosexual
- •intercourse during the entire period of risk associated with the study
- •requirements. • If the participant decides to become sexually active during the
- •study, then one of the highly effective birth control methods must be used. OR
- •Is a woman of non-childbearing potential; defined by at least 1 of the
- •following criteria: • Postmenopausal defined as 12 months of spontaneous
- •amenorrhea without a medical cause and follicle stimulating hormone (FSH) serum
- •level > 40mIU/mL without the use of hormonal supplementation. Appropriated
- •documentation of FSH levels is required. • Surgically sterile by hysterectomy
- •and/or bilateral oophorectomy with appropriate documentation of surgical
- •procedure. • Has a congenital condition resulting in no uterus. Informed
- •Consent 6. Capable of giving signed informed consent as described in Appendix 1
- •which includes compliance with the requirements and restrictions listed in the
- •informed consent form (ICF) and in this protocol.
排除标准
- •Participants are excluded from the study if any of the following criteria
- •apply: Medical Conditions 1. History or presence of alcoholism or drug abuse
- •within the past 2 years prior to the first dose of study drug. 2. History or
- •presence of hypersensitivity or idiosyncratic reaction to the study drug,
- •related compounds, or inactive ingredients. 3. ALT or AST levels three times
- •above the upper limits of normal (ULN) at screening (isolated elevations of
- •total bilirubin < 2 X ULN with direct bilirubin below the ULN will be
- •included). A recheck for confirmation is allowed. 4. History of documented,
- •EEG-confirmed epileptic seizures. 5. History of cancer (malignancy).
- •Exceptions: (1) Subjects with adequately treated non-melanomatous carcinoma or
- •carcinoma in situ of the cervix may participate in the trial (2) Subjects with
- •other malignancies who have been successfully treated >10years prior to the
- •screening where in the judgment of the investigator has revealed no evidence of
- •recurrence from the time of treatment through the time of the screening except
- •those identified at the beginning of the exclusion criterion or (3) Subjects
- •who in the opinion of the investigator are highly unlikely to sustain a
- •recurrence for the duration of the trial. 6. Currently has uncontrolled
- •diabetes defined as HbA1c > 8% at screening visit or diabetic neuropathy. 7.
- •Estimated creatinine clearance < 40mL/minute at screening visit. 8. Clinically
- •significant abnormality on their screening and/or prior to first dosing resting
- •ECG, other than hypertensive related, or heart failure (ejection fraction <
- •30%) or other clinically significant structural heart disease. 9. History of
- •myocardial infarction in the last five years, or evidence of congestive heart
- •failure. 10. Ongoing medical condition that is deemed by the PI to interfere
- •with the conduct or assessments of the study or safety of the subject.
- •Prior/Concomitant Therapy 11. Unable to refrain from or anticipates the use of:
- •Any non-approved medicines (prescribed standard-of-care for CPVT is approved)
- •and/or dietary supplements beginning 14 days prior to the first dose of study
- •drug and throughout the study. Thyroid hormone replacement medication may be
- •permitted if subject has been on same stable dose for the last 3 months prior
- •to the first dose of study drug. • Any drugs known to be significant inducers
- •or inhibitors of CYP2C8 enzymes for 28 days prior to the first dose of study
- •drug and throughout the study. Is currently taking any drug which raises
- •gastric pH, including proton pump inhibitors or H2 antagonists. Antacids may be
- •used if taken greater than 6 hours after study drug and/or at night.
- •Prior/Concurrent Clinical Study Experience 12. Participation in clinical trials
- •for other therapeutic investigational drugs simultaneously or within the 4
- •weeks prior to the first dose of study drug. Diagnostic Assessments 13. Plasma
- •donation within 7 days prior to the first dose of study drug. 14. Donation of
- •blood or significant blood loss within 56 days prior to the first dose of study
- •drug. Other Exclusion Criteria 15. Is mentally or legally incapacitated at the
- •time of screening visit. 16. Is unable to take orally administered tablets. 17.
- •Is an immediate family member of the Sponsor or employee of the clinical site
- •or may consent under duress
研究者
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