A Phase I, open-label, two-part, fixed sequence, three period crossover study to investigate the drug-drug interaction potential of INE963 and KAE609 (Part A) administered together, and a two period crossover study to investigate the effect of food on pharmacokinetics and safety of INE963 (Part B), in healthy participants.

ovartis Pharmaceuticals UK Limited0 个研究点目标入组 30 人开始时间: 2023年9月15日最近更新: 2023年11月6日

适应症

试验速览

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•1. Signed informed consent
•2. Healthy male and female* participants of non-childbearing potential * aged 18 to 55 years (inclusive)
•3. In good health as determined by medical history, physical examination, vital signs, ECG, and laboratory test at Screening or Baseline
•4. Vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed at Screening or Baseline in the supine position after at
•least five minutes rest in a quiet environment. Supine vital signs must be within the following ranges:
•oral body temperature between 35.0°C and 37.5°C
•systolic blood pressure between 90 mmHg and 140 mmHg
•diastolic blood pressure between 50 mmHg and 90 mmHg
•pulse rate between 45 bpm and 90 bpm
•5. Participants must weigh at least 50 kg with a body mass index (BMI) within the range of 18.0 kg/m²- 29.9 kg/m². BMI = Body weight (kg) / [Height (m)]², inclusive.

•1. Significant illness which has not resolved within two (2) weeks prior to initial dosing.
•2. A history of clinically significant ECG abnormalities, or any other ECG abnormalities considered clinically significant by the Investigator
•at Screening and/or Baseline, including but not limited to:
•QTcF > 450 msec (males)
•QTcF > 460 msec (females)
•3. Any clinically significant hematology parameters outside normal ranges as defined by the local laboratory at Screening and/or Baseline.
•Participants with neutrophils <1.5 x 10^9/L should be excluded.
•4. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which
•may jeopardize the participant in case of participation in the study. The Investigator should make this determination in consideration of the
•participant's medical history and/or clinical or laboratory evidence including but not restricted to any of the following at Screening or
•4.1. Use of any prescription drugs, over-the-counter (OTC) medication, herbal supplements, prescribed medicinal use of cannabis/marijuana,
•within four weeks prior to initial dosing, with the exception of coronavirus disease 2019 (COVID-19) vaccine which will be restricted within 2 weeks prior to first dosing.

发起方

ovartis Pharmaceuticals UK Limited