An Open-label, Single-center Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of a Single Dose of GRT6019, Including Food Effect, in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Events
研究概览
简要总结
The purpose of this trial is to evaluate the safety, tolerability, and Pharmacokinetics (PK) of a single oral dose of GRT6019 in healthy male participants, including food effect.
This is an open-label, single-dose, single-center Phase I trial with healthy male participants. The trial will consist of 2 cohorts with a total duration of approximately 7 weeks, including a 28-day Screening Period.
The participants will receive a single dose of GRT6019 administered on Day 1 and will remain at the clinic for 7 additional days.
Following the in-house stay, there will be 2 Follow-up Visits up until Day 23, with 3 clinic visits scheduled
详细描述
Cohort 1 and Cohort 2 will be dosed in parallel:
- Cohort 1 (n = 9): single dose of GRT6019 in participants in a fed state
- Cohort 2 (n = 9): single dose of GRT6019 in participants in a fasted state
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Main inclusion Criteria:
- •The participant must be able to give signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Participants must sign the ICF before any trial-related assessments.
- •The participant is in good health as determined by the medical history, physical examination, 12-lead Electrocardiogram (ECG), vital signs (heart rate [HR], respiratory rate [RR], systolic and diastolic blood pressure [BP]), body temperature, and clinical laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis) without clinically relevant (per investigator judgement) deviations from reference ranges unless further specified in the
排除标准
- •Main exclusion Criteria:
- •Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, comparator, rescue medication, or any ingredients therein, or may affect the interpretation of the results, or may render the patient at high risk from treatment complications/ participation in the study unsafe.
- •Major surgical procedure, within 3 months prior to ICF signing, or anticipation of need for a major surgical procedure during the trial.
- •Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or immunological disorder(s) as determined by the investigator.
- •Any medication, including herbal remedies or over-the-counter medication within 2 weeks before screening into this trial and anticipated use during the trial.
- •Concurrent enrollment in another clinical trial unless it is an observational (non-interventional) clinical trial or during the Follow-up Period of an interventional trial.
- •Recent participation in another clinical trial with an IMP administered within 30 days before Day 1 OR within 5 times the elimination half-life of the IMP, whichever is longer.
研究组 & 干预措施
GRT6019: Cohort 2
Fasted State
干预措施: GRT6019 (Drug)
GRT6019 :Cohort 1
Fed State
干预措施: GRT6019 (Drug)
结局指标
主要结局
Number of participants with Adverse Events
时间窗: Through study completion, an average of 7 Weeks
Assessment of safety and tolerability of GRT6019 after a single oral dose
Number of participants with serious Adverse Events
时间窗: Through study completion, an average of 7 Weeks
Assessment of safety and tolerability of GRT6019 after a single oral dose
Number of participants with Adverse Events leading to discontinuation
时间窗: Through study completion, an average of 7 Weeks
Assessment of safety and tolerability of GRT6019 after a single oral dose
Number of participants with Adverse Events related with GRT6019
时间窗: Through study completion, an average of 7 Weeks
Assessment of safety and tolerability of GRT6019 after a single oral dose
次要结局
- Ratio of the geometric mean of AUC0-inf(From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.)
- Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (AUC0-t)(From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.)
- Area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time (AUC0-inf )(From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.)
- Ratio of the geometric mean of AUC0-t(From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.)
- Maximum plasma concentration (Cmax)(From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.)
- Time of maximum plasma concentration (Tmax)(From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.)
- Lag-time observed from dosing to the time point prior to that of the first quantifiable plasma concentration (Tlag). Assessment of the PK of GRT6019 following a single oral dose of the pediatric formulation under fasted and fed conditions.(From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.)
- Terminal elimination half life (T₁/₂)(From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.)
- Total body oral clearance (CL/F)(From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.)
- Apparent volume of distribution (V/F)(From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.)
- Ratio of the geometric mean of Cmax(From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.)