NCT05972278进行中（未招募）1 期
A Placebo-Controlled, Phase 1 Study to Investigate the Effect of Obicetrapib on Lipoprotein Metabolism.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Treatment with obicetrapib (10 mg) on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL).
研究概览
简要总结
To determine the treatment effect with obicetrapib (10 mg) on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL).
详细描述
The study population will comprise 20 adults, 18 to 75 years of age, with LDL-C level ≥ 100 and ≤ 190 mg/dL, and in generally good health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to sign the Informed Consent Form.
- •Male or female between 18 to 75 years of age.
- •Females may be enrolled if they are not pregnant, are not breastfeeding, and do not plan on becoming pregnant during the study.
- •Stable weight (± 3 kg) for at least 6 weeks prior to screening.
- •Body mass index (BMI) of > 18.5 and ≤ 40 kg/m2 at Screening. BMI is calculated by taking the participants weight in kg and dividing it by the height in meters, squared.
- •Participant is judged to be in good health by the Study PI based on medical history, physical examination, vital sign measurements, electrocardiogram (ECG) assessments, and laboratory safety tests performed at Screening and/or prior to administration of the initial dose of study drug.
- •Fasting plasma triglyceride level ≤ 400 mg/dL at Screening.
- •LDL-C level of ≥ 100 mg/dL and ≤ 190 mg/dL at Screening.
排除标准
- •Has taken or plans to take any lipid-lowering medications or medications known to alter lipoprotein metabolism within 4 weeks of Screening, (e.g. statins, fibrates, niacin, cholesterol absorption inhibitors, bile acid-sequestrants, fish oils, PCSK9 inhibitors, red yeast rice, glucocorticoids, and anabolic agents).
- •Current, or any previous history of New York Heart Association (NYHA) class III or IV heart failure or left ventricular ejection fraction < 30%.
- •Uncontrolled hypertension defined as either systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg prior to the Baseline visit, taken as the average of triplicate measurements. One triplicate retest will be allowed during the same visit, at which point if the retest result is no longer exclusionary, the participant may be randomized.
- •HDL-C > 60 mg/dL if male or >70 mg/dL if female, at Screening.
- •An eGFR < 45 mL/min/1.73m2 at the Screening visit or history of end-stage renal disease (ESRD).
- •Active liver disease, defined as any known current infectious, neoplastic, or metabolic pathology of the liver; unexplained elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN); or total bilirubin > 2 x ULN at the and/or Screening visit.
- •History of stroke, chronic seizures, or major neurological disorder.
- •Participants on thyroid hormone replacement treatment at the time of screening, there is no lower thyroid stimulating hormone (TSH) threshold for entry. The subject must have been on a stable dose of thyroid hormone therapy for ≥ 6 weeks prior to the screening. If TSH levels are undetectable and a change in thyroid hormone therapy is recommended, or if this represents a new diagnosis, then the participant is not eligible. Note: Hypothyroidism is defined as having a TSH > 20% above the local laboratory's upper limit of the normal reference range. One redraw will be allowed if the original TSH value is equal to or less than 40% above the normal reference range at the local laboratory. The participant must meet his criterion upon redraw.
- •Participant with a history of neoplastic disease. Note: Participant treated non-melanoma skin carcinoma, and other malignancies which have been successfully treated ≥ 5 years prior to the Screening visit where, in the judgment of both the PI and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the Screening visit.
- •Has participated in another investigational drug study within 30 days of Screening
研究组 & 干预措施
Obicetrapib placebo
Placebo Comparator
identical matching placebo
干预措施: Obicetrapib (Drug)
Obicetrapib 10 mg
Experimental
10 mg tablets
干预措施: Obicetrapib (Drug)
结局指标
主要结局
Treatment with obicetrapib (10 mg) on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL).
时间窗: 8-12 week
The mean differences (obicetrapib - placebo) in the LDL apoB100 FCR using the baseline measure (no study treatment) compared to the LDL apoB100 FCR of each variable following the Treatment Period.
次要结局
- Treatment with obicetrapib (10 mg) on the production rate (PR) of apolipoprotein(a), or apo(a), in Lp(a).(8-12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese SubjectsHealthyNCT02059330Pfizer27
招募中
1 期
Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast CancerBreast CancerNCT05996107University of Michigan Rogel Cancer Center30
终止
1 期
Cardiovascular Safety Study of Tipifarnib in Patients With Advanced Solid MalignanciesAdvanced Solid TumorNCT04865159Kura Oncology, Inc.6
已完成
3 期
A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)OsteoporosisNCT01120600Merck Sharp & Dohme LLC294
已完成
1 期
Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal CancerColorectal CancerNCT00345761Chugai Pharmaceutical64