Safety, Tolerability and Pharmacokinetics of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Sā¦ (NCT06315387) | Clinical Trial Compass
UnknownPhase 1
Safety, Tolerability and Pharmacokinetics of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Single and Multiple Oral Administration in Healthy Volunteers
Russia42 participantsStarted 2023-12-04
Plain-language summary
Study of safety, tolerability and pharmacokinetic parameters of different doses of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers
Who can participate
Age range18 Years ā 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study prior to any of the study procedures;
ā. Males and females between the ages of 18 and 45 years (inclusive) of Caucasian race;
ā. Verified diagnosis of "healthy" (absence of abnormalities according to the data of clinical, laboratory, instrumental methods of examination stipulated by the protocol);
ā. Blood pressure (BP) level: systolic blood pressure (SBP) from 99 to 129 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mmHg (inclusive);
ā. Heart rate (HR) from 60 to 89 beats/min (inclusive);
ā. Respiratory rate (RR) from 12 to 20 per 1 minute (inclusive);
ā. Body temperature between 36.0Ā°C and 36.9Ā°C (inclusive);
ā. Body mass index (BMI) of 18.5 kg/m2 ā¤ BMI ā¤ 30 kg/m2, with body mass ā„ 55 kg for males and ā„ 45 kg for females;
Exclusion criteria
ā. Withdrawal of the volunteer from further participation in the study;
ā. Failure of the volunteer to comply with the rules of participation in the study (skipping study procedures, independent use of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);
ā. Causes/occurrence of situations during the study that jeopardize the safety of the volunteer (e.g. hypersensitivity reactions, etc.);
ā. Volunteers selected for participation in the study in violation of the inclusion/non-inclusion criteria;
ā. Development of serious/severe adverse event in a volunteer during the course of the study;
ā. Volunteer is receiving or requires treatment that may affect the pharmacokinetics of the study drug;
ā. Missing collection of 2 or more consecutive blood samples or 3 or more blood samples during a single Study Period;
ā. Occurrence of vomiting/diarrhea within 6 h of administration of study drug;
What they're measuring
1
Pharmacokinetics - Cmax
Timeframe: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
2
Pharmacokinetics - tmax
Timeframe: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
3
Pharmacokinetics - AUC0-t
Timeframe: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
4
Pharmacokinetics - AUC0-inf
Timeframe: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
5
Pharmacokinetics - AUCextr
Timeframe: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
6
Pharmacokinetics - t1/2
Timeframe: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)
7
Pharmacokinetics - kel
Timeframe: From 0 to 48 hours, (single dose); from 0 to 120 hours (multiple dose)