A Phase 1, Open Label, non-randomised Drug-Drug interaction (DDI) for GV-100 (Part 4)

INTERVENTION: The Drug‐drug Interaction part will evaluate the effect of GV‐100 on cytochrome (CYP) 3A4 and cytochrome (CYP) 2B6 activity and may be initiated after Safety Review Committee (SRC) approval of safety, tolerability, and Pharmacokinetic (PK) data from multiple ascending dose (MAD) Cohort 3. The GV‐100 dose will be selected based on cumulative safety and Pharmacokinetic (PK) data. Approximately 12 participants will be enrolled in a fixed‐sequence, non‐randomized, open‐label design. Probe substrates will include midazolam 1 mg (cytochrome (CYP) 3A4 substrate) and bupropion 75milligram (cytochrome (CYP) 2B6 substrate), both administered orally. Participants will be screened between Day ‐28 and Day ‐2, admitted on Day ‐1, confined through Day 15, and return for follow‐up on Day19 (±1 day). Participants will be administered a single oral dose of 1 mg midazolam, immediately followed by a single oral dose of 75 mg bupropion on Day 1. On Day 11, the participants will be administered a single oral dose of 1 mg midazolam, immediately followed by a single oral dose of 75 mg bupropion, immediately followed by a single oral dose of GV‐100. Participants will be admitted to hospital as inpatient and the administration for the selected dose of GV‐100QD for 7 consecutive days from Days 6 to 12. A mouth check will be performed following administration to confirm complete consumption of the IP. CONDITION: Autosomal Dominant Polycystic Kidney Disease (ADPKD); ; Autosomal Dominant Polycystic Kidney Disease (ADPKD) Renal and Urogenital ‐ Kidney disease PRIMARY OUTCOME: Safety and tolerability will be assessed comparatively as a composite outcome.[presence of Adverse Event's (AE), vital signs (blood pressure and heart rate measured using Blood pressure Machine, respiratory rate measured Manually, and body temperature measured using standard Thermometer), 12‐lead Electrocardiogram (ECG) recordings, and safety laboratory tests (Standard biochemistry (fasted), hematology, coagulation, and urinalysis tests), will be assessed collectively.; GV‐100 has not yet been administered to humans; therefore, no human safety data is available. HDAC6 inhibitors, such as GV100, have been associated with adverse reactions including gastrointestinal symptoms (primarily diarrhea and nausea) , Fatigue, generally mild to moderate in severity, and hematologic changes. ; Part 4: Drug‐Drug Interaction (DDI) ; ; Vital Signs: At screening, on Day ‐1, on Day 1 prior to midazolam dosing and 1, 3, and24 (Day 2) hours post‐bupropion‐dose, on Days 6, 7, 8, 9, and 10 prior to GV‐100 dosing, on Day 11 prior tomidazolam dosing and 1, 3, and 24 (prior to GV‐100 dosing on Day 12) hours post‐GV‐100‐dose, on Day 15prior to discharge, and at follow‐up (or End of Treatment (Day19)). ; ; Safety Laboratory Test: At screening, on Day ‐1, at 24 hours post‐bupropion dose (Day 2), on Days 6,8, 10, and 12 prior to GV‐100 dosing, on Day 15 prior to discharge, and atfollow‐up (or End of Treatment (Day19)).; ; 12Lead Electrocardiogram (ECG): at screening, on Day ‐1, on Day 1 prior to midazolam dosing, on Day 6 prior to GV‐100 dosing and 4, 12, and 24 (prior to GV‐100 dosing on Day 7) hours post‐dose, on Days 8, 9, and 10prior to GV‐100 dosing, on Day 11 prior to midazolam dosing and 4, 12, and 24 (prior to GV‐100 dosing on Day 12) hours post‐GV‐100 dosing, on Day 15 prior to discharge, and at follow‐up (or End of Treatment (Day19)). ; ; Adverse Event: From screening to follow up /End of Study/End of Treatment (Day19).] SECONDARY OUTCOME: Plasma PK parameters of GV‐100, midazolam, 1‐hydroxymidazolam, bupropion, 6‐hydroxybupropion including, but not limited to: area under the concentration‐time curve from time zero until the last observed concentration (AUClast), AUC0‐inf, maximal observed concentration (Cmax), and terminal elimination half‐life (T½). This will be assessed comparatively as a composite outcome[Part 4 Drug‐Drug Interaction Only Plasma concentrations of GV‐100, midazolam, and bupropion will be measured during the study. Where feasible, pharmacokinetic (PK) parameters—including, but not limited to, terminal elimination half‐life (T½), time when the maximal concentration is observed (Tmax), maximal observed concentration (Cmax), area under the concentration‐time curve from time zero until the last observed concentration (AUClast), area under the concentration‐time curve from time zero to infinity ; (extrapolated) (AUC0‐inf), and metabolite‐to‐parent ratios for maximal observed concentration (Cmax) and area under the concentration‐time curve from time zero until the last observed concentration (AUClast)—will be calculated using non‐compartmental methods, as appropriate. This will be assessed comparatively as a composite outcome Bupropion PK Blood Samples ; ; Day 1: Pre‐Dose (Within 30 minutes prior to midazolam dosing), 0.5 hours, 1hours, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours, Day2: 24 hours, ; ; ; Day 3 : 48 hours, Day 4: 72 hours, Day5: 96 hours, ; ; Day 11: Pre‐dose (Within 30 minutes prior to midazolam dosing), 0.5 hours, 1 hours, 2 hours, 4hours, 6, hours, 8 hours, 12 hours, ; ; Day 12: 24hours, Day 13: 48 hours, Day 14: 72 hours and Day 15: 96 hours ; ; Midazolam PK Blood Samples ; ; Day1: Pre ‐Dose (Within 30 minutes prior to midazolam dosing), 0.5 hours, 1hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, Day2: 24 hours, ; ; Day 11: Pre ‐Dose (Within 30 minutes prior to midazolam dosing), 0.5 hours, 1 hours, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours Day 12:24Hours. ; ; PK Analysis of GV‐100: ; Day6: Pre‐dose (within 30min prior to GV‐100 dosing), 0.5 hours, 1 hours, 2 hours, 4hours, 6, hours, 8 hours, 12 hours, ; Day7: 24Hours (Within 30 minutes prior to GV‐100 dosing) ; Day 8‐Day10: Pre‐dose (Within 30 minutes prior to GV‐100 dosing) ; Day11: Pre‐dose Within 30 minutes prior to midazolam dosing ), 0.5 hours, 1 hours, 2 hours, 4hours, 6, hours, 8 hours, 12 hours, ; Day12: 24Hours (Within 30 minutes prior to GV‐100 dosing) ; ; The outcomes above are composite outcomes.] INCLUSION CRITERIA: ‐ Male or female participants, aged more than or equal 18 to less than or equal to 65 years at the time of providing informed consent, who are non‐smokers (no use of tobacco or nicotine‐containing products within 3 months prior to screening), with a body mass inde X(BMI) greater than 18.0 and less than 32.0kilogram/meter square, and a minimum body weight of 50.0 kilogram. ‐ Healthy individuals, as determined by the Principal Investigator or delegate, defined as: a. No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration. b. No clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disorders. ‐ Capable of understanding the study procedures and willing to provide written informed consent prior to participation.