A Phase I, 7-Day Dosing Study of 200 Mg IkT-148009 to Determine the Safety, Tolerability and Pharmacokinetics (PK) of IkT-148009 in Older Adult and Elderly Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Participant Safety - clinical lab values
研究概览
简要总结
This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules.
详细描述
This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules.
This is a single arm study with subjects to treatment with IkT-148009 only. The study will consist of a total of up to 15 visits over a period of up to 29 days prior to dosing, 7 days of dosing and 14 days of follow up.
Subjects will receive a single daily dose of study drug with a meal for a period of up to 7 days. A full breakfast must be consumed prior to receiving the dose study drug. Subjects will be confined to the unit for approximately 12 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must have all questions about the study answered and must have signed the informed consent document before any study-specific procedures are performed.
- •Men or women aged 45 to 70 years at screening (both inclusive) of any race.
- •Subjects must be otherwise healthy and ambulatory, with no history or evidence of clinically relevant medical disorders
- •Mini Mental State Examination (MMSE) ≥ 28
- •Physical examination, clinical laboratory values, vital signs, and the electrocardiogram (ECGs) are clinically acceptable to the Investigator. Body weight ≥ 45 kg. Body Mass Index (BMI) ≥ 18 and ≤33 kg/m
- •Female subjects must be postmenopausal or surgically sterile or sterile for other medical reason.
- •Male subjects must agree to practice an acceptable method of highly effective birth control.
- •Males must be willing to abstain from sperm donation from the screening visit, while on study and through 30 days after receiving the last dose of study drug.
排除标准
- •Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and admission visits.
- •Clinically significant abnormal findings on physical examination or 12-lead electrocardiogram (ECG) at the screening or admission visits.
- •Significant history (within six months prior to receiving the study drug) and/or presence of clinically significant medical, surgical or psychiatric disorder in the judgement of the investigator.
- •History of clinically significant problems in the retina as reported by a subject
- •eGFR < 60 mg/mL
- •Creatinine, Amylase and/or Lipase > ULN
- •Any malignancy in the 5 years prior to screening excluding basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated.
- •Any subject with a history, presence and/or current evidence of serologic positive result for hepatitis B surface antigen, hepatitis C antibodies, or HIV antibodies 1 or
- •Subjects considered to be cured for hepatitis C will be eligible.
- •Recent history (within previous six months prior to screening) of alcohol or drug abuse (as judged by the investigator) or has consumed > 2 alcohol drinks/day during the last three months prior to screening.
- •Any subject with known hypersensitivity to IkT-
- •Donation of blood, plasma, or acute loss of blood within 60 days prior to screening visit.
- •Use of tobacco or nicotine-containing products during the 60 days prior to screening and for the duration of the study.
- •Any subject who has received treatment with an investigational drug during the 30 days prior to screening.
- •Investigative site personnel or their immediate families (spouse, parent, child or sibling whether biological or legally adopted).
- •Any subject unwilling or unable to comply with study procedures.
研究组 & 干预措施
200mg
IkT-148009 will be administered as 4x50mg gelatin capsules
干预措施: 200mg of Ikt-148009 (Drug)
结局指标
主要结局
Participant Safety - clinical lab values
时间窗: Through study completion, an average of 50 days
Changes in clinical laboratory data consisting of CBC, Serum Chemistry, FSH.
Participant Tolerability
时间窗: Through study completion, an average of 50 days
Percent completers
Participant Safety
时间窗: Through study completion, an average of 50 days
C-SSRS assessment values.
Participant Safety - vital signs
时间窗: Through study completion, an average of 50 days
Changes in vital sign measurements including HR and blood pressure.
Assess the pharmacokinetics (PK) of IkT-148009
时间窗: Through study completion, an average of 50 days
Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to last time point (AUC0-last)
次要结局
未报告次要终点