A single-center, open-label, fixed-sequence Phase 1 trial to evaluate the effect of multiple doses of pritelivir on the pharmacokinetics of substrates for CYP2C9, CYP2B6, CYP3A4 and OATP2B1 - Pritelivir DDI study with celiprolol, flurbiprofen, bupropion and midazolam

AiCuris Anti-infective Cures AG0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•- Subject has been informed both verbally and in writing about the objectives
•of the clinical trial, the methods, and the potential risks and the discomfort
•to which he/she may be exposed and has given written consent to participation
•in the trial prior to trial start and any trial related procedure.
•- Healthy male and female subjects of any ethnic origin, aged between 18 and 55
•years (inclusive). Assessed as healthy based on a pre-trial examination
•including medical history,
•physical examination, blood pressure, pulse rate, body temperature, ECG
•assessment, and clinical laboratory results.
•- In women negative serum β-HCG (beta-human chorionic gonadotropin) test at
•screening and
•negative urine β-HCG test on Day -1.
•- Subject agrees to pharmacogenetic blood sampling.
•- Normal body weight as evidenced by a Body Mass Index (BMI) >=18.0 and <=30.0
•kg/m2, and a body weight >=50.0 kg at Screening.
•More criteria apply

•1. History or current evidence of clinically relevant allergies or idiosyncrasy
•to drugs or food.
•2. History of allergic reactions to any active or inactive ingredient(s) of the
•Investigational Medicinal Products (IMPs).
•3. History or current evidence of any clinically relevant cardiovascular,
•pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological,
•metabolic, neurological, psychiatric, or other disease suspected to influence
•pharmacokinetics or safety of the IMPs.
•4. History of malignancy within 5 years, unless one of the following, treated
•and considered cured: basal cell carcinoma, in situ cervical cancer, or breast
•ductal carcinoma in situ.
•5. Resting pulse rate after 5 minutes in supine position at Screening and Day
•-1: <45 or >100 beats per minute (bpm), if out of range, up to one repeat
•assessment is allowed.
•More criteria apply

发起方