ISRCTN10379288进行中（未招募）1 期
An open-label, drug-drug interaction study designed to evaluate the potential effect of miricorilant on cytochrome P450 2C8, 2C9, 3A4, uridine-diphospho-glucuronosyltransferase 1A1 enzyme activity, and breast cancer resistance protein activity using probe substrates in healthy male and female subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- 性别
- All
入选标准
- •1. Provide written informed consent
- •2. Willing and able to communicate and participate in the whole study
- •3. Aged 18 to 60 years inclusive at the time of signing the informed consent
- •4. Agree to adhere to the contraception requirements defined in the clinical protocol
- •5. Male subjects or non-pregnant, non-lactating female subjects of non-childbearing potential
- •6. Participants who are healthy as determined by medical evaluation including medical history, physical examination, vital signs, 12-lead ECGs, screening clinical laboratory profiles (haematology, clinical chemistry, and urinalysis), as deemed by the Investigator or designee
- •7. Body mass index (BMI) of 19.0 to 32.0 kg/m2 as measured at screening
- •8. Body weight =50 kg at screening
排除标准
- •1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- •2. Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hay fever is allowed unless it is active
- •3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease (including cholecystectomy), bleeding disorder, neurological or psychiatric disorder, as judged by the Investigator.
- •4. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator or delegate at screening
- •5. Clinically significant abnormal clinical chemistry (including AST and/or ALT >1.5 × the upper limit of the reference range or CK >1.5 × ULN), haematology or urinalysis as judged by the Investigator (laboratory parameters are listed in the clinical protocol). Subjects with Gilbert’s Syndrome are allowed
- •6. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or (HIV) 1 and 2 antibody results
- •7. Evidence of renal impairment at screening, as indicated by an estimated glomerular filtration rate (eGFR) of <80 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009) equation
- •8. Female subjects of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative highly sensitive serum (at screening) or urine (at admission) pregnancy test)
- •9. Clinically significant ECG abnormalities or vital sign abnormalities at screening or baseline (pre-first dose) including but not limited to:
- •9.1. QTcF > 450 msec based on a single ECG at screening, and based on the mean of 3 supine ECGs performed at least 2 minutes apart at Day 1 pre-dose
- •9.2. Supine heart rate (HR) at rest of <40 bpm or >100 bpm at screening and pre-(first) dose
- •9.3. Blood pressure (BP) outside the following ranges: diastolic BP 40-90 mmHg; systolic BP 90-140 mmHg (subjects aged 18-45 years) and 90-160 mmHg (subjects aged >45 years) at screening or before the first dose of study medication (NIMPs or IMP). HR and BP can be retested twice in the supine position at intervals of approximately 5 minutes on a given day
- •10. Subjects who have received any IMP or NIMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- •11. Subjects who report having received miricorilant in the 6 months before the first dose of miricorilant in this study
- •12. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- •13. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies (other than up to 4 g of paracetamol per day in the 14 days before first NIMP administration). COVID-19 vaccines are accepted as concomitant medications
- •14. Subjects who are currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within 12 calendar months before the first NIMP administration, or 90 days for inhaled glucocorticoids. Subjects who have received up to two single doses of a glucocorticoid in another study more than 90 days before the first dose of study medication will not be excluded from taking part in the study for this reason
- •15. Any contraindication to the use of repaglinide, tolbutamide, midazolam, dolutegravir, rosuvastatin as per the Summary of Product Characteristics (SMPC) fo
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