A 2-part study in healthy volunteers to assess the safety and tolerability of the test medicine and explore how it is taken up by the body following single and multiple doses with an optional third part and to compare how the test medicine is taken up by the body when compared to an existing formulation (recipe)

INTERVENTION: Parts 1 and 2 are randomised, double‐blind and placebo controlled assessing single and multiple ascending doses. Optional Part 3 is a randomised open‐label assessment comparing the test medicine to a reference product. Volunteers are expected to be involved in this study for seven (Part 1 or 2) or si X(Part 3) weeks from screening to the follow up visit. CONDITION: Acute Kidney Injury (AKI) ; Urological and Genital Diseases PRIMARY OUTCOME: ; Safety and tolerability will be assessed throughout the study, from dosing to follow up visits (Day 1 to Day 11 in Part 1 and Part 3, Day 1 to Day 15 in Part 2); Part 1: To provide safety and tolerability information for UNI‐494 by assessing: incidence of adverse events (AEs), physical examination findings and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests; Part 2: To provide safety and tolerability information for UNI‐494 by assessing: incidence of AEs, physical examination findings and change from baseline for vital signs, ECGs, and laboratory safety tests; ; Part 3 (optional): Nicorandil relative bioavailability (Frel) based on a within subject comparison for Cmax, AUC(0‐last) and AUC(0‐inf) of the UNI‐494 Capsule compared to the nicorandil marketed product (tablet) through measurement of plasma samples taken in Part 3 from dosing to discharge, across both periods.; SECONDARY OUTCOME: ; Pharmacokinetic parameters will be measured using analysis of plasma samples taken from pre‐dose to 48 hours post‐dose in all Parts. Relative bioavailability will be assessed through measurement of plasma samples taken in Regimen E, should this be utilised. Samples will be taken from pre‐dose to 48 hours post‐dose in both periods. Safety and tolerability will be assessed throughout the study, from dosing to follow up visits (Day 1 to Day 11 in Part 3).; ; Part 1:; 1.1. Following PK parameters for UNI‐494, nicorandil and 1‐cyclohexylethylamine will be calculated (where possible and appropriate): Tlag, Tmax, Cmax, C24, AUC(0‐24), AUC(0‐last), AUC(0‐inf), AUCextrap, Lambda‐z, T1/2, metabolite to parent ratios (MPR) based on AUC and Cmax, CL/F, Vz/F and MRT; 1.2. Relative bioavailability based on a within cohort comparison for Cmax, AUC(0‐last) and AUC(0‐inf) for UNI‐494, nicorandil and 1‐cyclohexylethylamine following dosing of the UNI‐494 capsule in the fed versus the fasted state; ; Part 2: Following PK parameters for UNI‐494, nicorandil and 1‐cyclohexylethylamine will be calculated (where possible and appropriate) Tlag, Tmax, Cmax, C24, AUC(0‐tau), AUC(0‐last), Lambda‐z, T1/2, metabolite to parent ratios (MPR) based on AUC and Cmax, accumulation ratios based on Cma Xand AUC, CL/Ftau, Vz/Ftau and MRT; ; Part 3 (optional); 3.1. Following PK parameters for UNI‐494, nicorandil and 1‐cyclohexylethylamine will be calculated (where possible and appropriate): Tlag, Tmax, Cmax, C24, AUC(0‐24), AUC(0‐last), AUC(0‐inf), AUCextrap, Lambda‐z, T1/2, metabolite to parent ratios (MPRs) based on AUC and Cmax, CL/F, Vz/F and MRT; 3.2. To provide further safety and tolerability information for UNI‐494 by assessing: incidence of AEs, physical examination findings and change from baseline for vital signs, ECGs, and laboratory safety tests; INCLUSION CRITERIA: 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 inde X(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