This three-part, first-in-human, healthy volunteer study aims to assess the safety and tolerability of the test medicine as well as how it is taken up by the body when given as single and multiple doses. The effect of food on the test medicine will also be investigated. In Part 1, up to 40 volunteers will be split into up to 5 groups and will receive single oral doses of the test medicine or dummy medicine (placebo), at different dose levels. In Part 2, up to 8 volunteers will receive one oral dose of the test medicine in the fed state and one oral dose in the fasted state. In Part 3, up to 24 volunteers will be split into up to 3 groups and will receive single oral daily doses of the test medicine or placebo for 3 consecutive days. Volunteers' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. In Part 1 and Part 3, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on two occasions for safety assessments to be performed. In Part 2, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on a single occasion for safety assessments to be performed. Volunteers are expected to be involved in this study for approximately 6 weeks for all study parts, from screening to the final return visit.
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Number of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Screening/day-28 to EoS (End of Study) visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total.
Number of Clinically Significant Physical Examination Findings
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Changes From Baseline for Electrocardiograms (ECGs): RR Interval (The R-R Interval is the Distance Between Two Consecutive R Waves.)
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2, and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Clinically Important Changes From Baseline for Respiratory Rate
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2,and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Clinically Important Changes in Heart Rate, Supine
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2, and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Clinically Important Changes in Heart Rate, Orthostatic
Timeframe: Screening/day-28 to Day 7 in Part 1, Day 15 in Part 2, and Day 9 in Part 3, up to a maximum of 6 weeks in total
Number of Clinically Important Changes From Baseline for Blood Bressure in mmHg: Orthostatic
Timeframe: Screening/day-28 to Day 7 in Part 1, Day 15 in Part 2, and Day 9 in Part 3, up to a maximum of 6 weeks in total
Number of Participants With Changes From Baseline For Electrocardiograms (ECGs): QTcF (Corrected QT Interval Using the Fridericia Formula)
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Clinically Important Changes From Baseline for Blood Pressure in mmHg: Supine
Timeframe: Screening/day -28 to EoS visit (Day 15 in Part 1, Day 14 in part 2, and Day 17 in Part 3). Up to a maximum of 6.5 weeks in total.