ISRCTN11462643进行中（未招募）1 期
A randomised, open-label, two-period, parallel group design, phase I study to assess the effect of food, pharmacokinetics and pharmacodynamics of roginolisib (IOA-244) in healthy subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- iOnctura SA
- 入组人数
- 32
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.Healthy Male or Female participant, 18 years of age and over, inclusive.
- •2.Female participant of childbearing potential willing to use a highly effective method of contraception, if applicable (unless of non childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from the first dose until 3 months after the last dose of IMP.
- •3.Female participant of non-childbearing potential. For the purposes of this study, this is defined as the participant being amenorrhoeic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral salpingectomy or bilateral oophorectomy with or without hysterectomy).
- •4.Female participant with a negative pregnancy test at Screening.
- •5.Female participant of menopausal status confirmed by demonstrating at Screening that the serum level of the follicle stimulating hormone (FSH) falls within the respective pathology reference range.
- •6.Male participant (and partner of childbearing potential) willing to use a highly effective method of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from first dose until 3 months after last dose of IMP.
- •7.Participant with a body mass index (BMI) of 18-32 kg/m².
- •8.No clinically significant history of previous allergy / sensitivity to IOA-244 or any of the excipients contained within the IMP.
- •9.No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 35 days before the first dose administration of the IMP. Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 35 days before the first dose administration of the IMP (N.B.: A positive test result may be repeated at the Investigator’s discretion).
- •10.Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg)) and hepatitis C virus antibody (HCV Ab) test results at Screening.
- •11.No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 35 days before first dose of IMP including a PR interval = 220ms, QT interval corrected using Fredericia’s formula QTcF =450ms for males and <470 for females, or any clinically significant abnormality in the resting ECG, as judged by the Investigator.
- •12.No clinically significant abnormalities in vital signs (e.g., blood pressure/heart rate) determined within 35 days before first dose of IMP. Supine Systolic BP =150 or >90 mmHg/Diastolic BP= 90 or >50 mmHg after resting for =3 minutes. Supine heart rate, after resting for =3 minutes, outside the range of 40 to 100 bpm. The Sponsor may allow exceptions if they are not deemed clinically significant.
- •13.Participant must be available to complete the study (including all follow-up visits).
- •14.Participant must satisfy an Investigator about his/her fitness to participate in the study.
- •15.Participant must provide written informed consent to participate in the study.
- •16.Participants with a negative COVID-19 test on admission (if required).
排除标准
- •1.A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
- •2.Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days and antibiotics within 35 days or 5 half-lives (whichever is longer) prior to the first dose of IMP.
- •3.Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- •4.A clinically significant history of drug or alcohol abuse (defined as the consumption of more than 14 units [for male and female participants] of alcohol a week) within the past two years.
- •5.Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function).
- •6.Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or five half-lives, whichever is longer, or a marketed drug clinical study within the 30 days or five half-lives, whichever is longer, before the first dose of IMP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- •7.Donation of 450 mL or more blood within the 35 days before the first dose of IMP.
- •8.Vegans, vegetarians or other dietary restrictions (e.g., restrictions for medical, religious or cultural reasons, etc) which would preclude a participant from consuming a standardised high-fat breakfast.
- •9.Consumption of alcohol and/or food and beverages containing methylxanthines, grapefruit, grapefruit juice, Seville oranges, or Seville orange juice within 72 hours prior to dosing.
- •10.Users of nicotine products i.e., current smokers or ex-smokers who have smoked within the 6 months prior to Screening or users of cigarette replacements (i.e., e-cigarettes, nicotine patches or gums).
- •11.Female participants who are pregnant, breastfeeding or lactating.
- •12.Participants with veins unsuitable for venepuncture and cannulation.
- •13.Participants with a haemoglobin value less than the lower limit of normal at screening or initial admission.
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