Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4
This open-label study will evaluate the effect of food on the bioavailability of a single dose of 4-MUST, tablets, 128 mg. Additionally, the study will assess the pharmacokinetics, safety, and tolerability of 4-MUST, tablets, 128 mg following both single and multiple oral dose administration.
| Condition(s) | Chronic Cholecystitis, Biliary Dyskinesia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This open-label study will evaluate the effect of food on the bioavailability of a single dose of 4-MUST, tablets, 128 mg. Additionally, the study will assess the pharmacokinetics, safety, and tolerability of 4-MUST, tablets, 128 mg following both single and multiple oral dose administration. |
| Who can participate | Inclusion Criteria: * Voluntary, personally signed ICF obtained prior to any study procedures; * Males and females aged 18 to 45 years (inclusive) of Caucasian race; * Confirmed healthy status based on the absence of clinically significant abnormalities in clinical, laboratory, and diagnostic assessments specified in the protocol; * Blood pressure (BP): systolic blood pressure (SBP) from 99 to 129 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mmHg (inclusive); * Heart rate (HR) from 60 to 89 beats/min (inclusive); * Respiratory rate (RR) from 12 to 20 per 1 minute (inclusive); * Body temperature from 36.0°C to 36.9°C (inclusive); * Body mass index (BMI) of 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2, with body weight ≥ 55 kg for males and ≥ 45 kg for females; * Commitment to adhere to hig |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Valenta Pharm JSC |
| Locations | Moscow, Russia |
| Start date | 2026-01-26 |
| NCT ID | NCT07594977 |
| Official listing | https://clinicaltrials.gov/study/NCT07594977 |