A Single-centre, Open-label, Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Determination of Maximum Plasma Concentration [Cmax] of IRL757
研究概览
简要总结
This is a phase I trial evaluating the pharmacokinetics of single ascending oral doses of IRL757 in healthy elderly volunteers.
详细描述
The trial is open label single oral dose trial in elderly healthy volunteers that will assess the pharmacokinetics of two dose levels of IRL757.
Eligible and consenting participants will be included in one of two dose groups, with 6 participants in each dose group.
At the screening visit, consenting subjects will be screened for eligibility according to study specific inclusion/exclusion criteria within 4 weeks before Investigational Medicinal Product (IMP) administration.
If eligible, participants will be admitted to the phase 1 clinic for the single dose administration of the IMP. All participants will receive active treatment (IRL757).
A follow-up visit will be performed for all participants, 5-10 days after IMP administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give written informed consent for participation in the trial.
- •Healthy male or postmenopausal female subject at ≥ 65 and below 90 years of age.
- •Weight of at least 50 kg and no more than 110 kg at screening.
- •Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
- •Willing to use highly effective methods of contraception
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the trial, or influence the results or the subject's ability to participate in the trial.
- •GFR less than 45 mL/min at screening.
- •History or present clinically significant psychiatric diagnosis, at discretion of the Investigator.
- •Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
- •History of seizures, including febrile seizure in childhood.
- •Any clinically significant illness, medical/surgical procedure or trauma within four (4) weeks of the first administration of IMP.
- •Any planned major surgery within the duration of the trial.
- •Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
- •After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:
- •Systolic blood pressure above 150 mm Hg
- •Diastolic blood pressure above 90 mm Hg
- •Heart rate less than 40 or above 90 beats per minute
- •Prolonged QTcF (above 450 ms for male subjects or 470 ms for female subjects), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- •History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to IRL
- •Use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins and minerals within two (2) weeks prior to the first administration of IMP
- •Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical trial that included drug treatment within three (3) months of the first administration of IMP in this trial.
- •Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than three (3) times per week is allowed before screening visit.
- •History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- •Positive screen for drugs of abuse at screening or on admission to the unit or positive screen for alcohol at screening or on admission to the unit prior to administration of the IMP.
- •Use of anabolic steroids.
- •Current excessive use of caffeine, as judged by the Investigator.
- •Plasma donation within one (1) month of screening or any blood donation/blood loss more than 450 mL during the three (3) months prior to screening.
- •Investigator considers the subject unlikely to comply with trial procedures, restrictions and requirements.
研究组 & 干预措施
IRL757 Dose Level 1
IRL757 lower dose, single dose
干预措施: IRL757 (Drug)
IRL757 Dose Level 2
IRL757 higher dose, single dose
干预措施: IRL757 (Drug)
结局指标
主要结局
Determination of Maximum Plasma Concentration [Cmax] of IRL757
时间窗: PK followed until 48 hours
Cmax after single dosing
Determination of the AUC of IRL757 and Its Main Metabolites
时间窗: PK followed until 48 hours
AUC 0 - inf for IRL757 and main metabolites M1 and M5 determined from PK sampling 0-48h post dosing
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its Main Metabolites
时间窗: PK followed until 48 hours
Determination of the time for maximum concentration \[Tmax\] of IRL757 and its main metabolites M1 and M5
Determination of the Half-life [t1/2] of IRL757 and Its Main Metabolites
时间窗: PK followed until 48 hours
Determination of the Renal Clearance (CLr) of IRL757
时间窗: PK followed until 48 hours
Determination of the renal clearance (CLr) of IRL757 based on urine and plasma sampling over 48 h
次要结局
- Evaluation of Frequency, Seriousness and Intensity of Adverse Events(From enrollment (within 4 weeks before Investigational Medicinal Product (IMP) administration, until end of follow-up (5 to 10 days after lMP administration))
- Description of Physical Examination Findings(Until 5-10 days after IMP administration)
- Description of Electrocardiogram Findings(Until 5-10 days after IMP administration)
- Description of Vital Signs Findings(Until 5-10 days after IMP administration)
- Description of Safety Laboratory Measurements(Until 5-10 days after IMP administration)
- Description of C-SSRS (Columbia Suicide Severity Rating Scale) Findings(Until 5-10 days after IMP administration)