A Phase 1b, Open-Label, Parallel Single-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Tinlarebant in Healthy Volunteers Aged 50-85

RBP4 Pty Ltd0 个研究点目标入组 15 人开始时间: 2022年12月7日最近更新: 2023年2月27日

适应症

试验速览

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•1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
•2. Healthy adult male or female, or adult male or female with a stable chronic disease or condition aged 50-85 years of age, inclusive. Adults with stable chronic disease or condition includes adults with no new diagnosis, hospitalisation or changes In medication in the 3 months prior to first dose of study drug on Day 1. Ongoing concomitant medications associated with the stable disease or condition, including over-the-counter (OTC) medications and herbal/vitamin supplements taken by volunteers, will be recorded and reviewed by the PI (or delegate) to determine whether the volunteer is suitable for inclusion in the study.
•3. The volunteer is considered by the Investigator to be in stable health

•1. Presence of clinically significant (CS) cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, orpsychiatric disease, or any other condition that, in the opinion of the Investigator, would jeopardise the safety of the participant or the validity of the study results.
•2. Point no 2 updated in public notes.
•3. A history of uncontrolled hypertension, coronary artery disease, or any other significant cardiovascular disease.
•4. A history of uncontrolled diabetes. Volunteers with fully resolved gestational diabetes will be eligible to participate in the study.
•5. A history of unexplained loss of consciousness, epilepsy or other seizure disorder, or cerebrovascular disease.

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