A two-part phase 1 study to assess the safety, tolerability and pharmacokinetics of UNI-494 with an optional third-part to assess the relative bioavailability compared to nicorandil in healthy male and female subjects

nicycive Therapeutics Inc.0 sites64 target enrollmentNovember 25, 2022

Overview

No summary available.

Registry

who.int

Start Date

November 25, 2022

End Date

February 25, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

nicycive Therapeutics Inc.

•1\. Must provide written informed consent
•2\. Must be willing and able to communicate and participate in the whole study
•3\. Subjects must be willing and able to swallow multiple capsules
•4\. Aged 18 to 55 years inclusive at the time of signing informed consent
•5\. Must agree to adhere to the contraception requirements defined in the clinical protocol
•6\. Healthy males or healthy females of non\-childbearing potential
•7\. Body mass index (BMI) of 18\.0 to 32\.0 kg/m² as measured at screening
•8\. Weight \=50 kg at screening
•9\. Must have a normal blood pressure defined as a systolic BP between 100 and 140 mmHg, diastolic BP between 40 and 90mmHg after 5 mins supine
•10\. No evidence of postural hypotension (defined as a dizziness / light headedness or a drop is systolic BP \>20mmHg or drop in diastolic BP \>10 mmHg when assessed 3 minutes after standing

•1\. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
•2\. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
•3\. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
•4\. Subjects with a history of cholecystectomy or gall stones
•5\. Subjects with any past history of gastrointestinal ulceration (e.g. peptic ulcer disease), gastrointestinal haemorrhage, diverticular disease or recent (within 6 months) symptoms of dyspepsia lasting 2 weeks or more
•6\. Recurrent and recent history of simple faints, vasovagal presyncope/syncope or blackouts
•7\. Subjects with glucose\-6\-phosphate dehydrogenase deficiency
•8\. Subjects with a history of conjunctival or corneal ulceration within the past 12 months.
•9\. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
•10\. Evidence of current SARS\-CoV\-2 infection