None (for healthy volunteers) Healthy volunteers
Conditions
Interventions
The dosage and administration period for each step.
-Part A-
Cohort 1: A single fasting dose of 5 mg MA-5 or 1 placebo capsule.
Cohort 2: MA-5 10 mg or placebo, 1 capsule, given as a single dose on a
Sponsors
Sambe Takehiko
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Gender: Male (Japanese) 2) Age: 20 years old or older but less than 45 years old (at the time of obtaining consent) 3) BMI at the time of screening examination: 18.5 to 25.0 kg/m2 (rounded to the first decimal place) 4) Those who are judged to be healthy by the investigator or others as a result of investigations, observations, and tests (clinical examination, 12-lead electrocardiography, etc.) conducted at the time of screening and hospitalization 5) Patients who have received sufficient explanation of the contents of the clinical trial from the investigator, understand the purpose of the clinical trial, voluntarily to participate in the clinical trial, and are able to provide written consent of their own free will to participate in the clinical trial, and who are judged to be appropriate for participation in the clinical trial by the investigator.
Exclusion criteria
Exclusion criteria: 1) Those who have used the drug within 7 days prior to the first dose of the investigational drug 2) Patients who have a primary disease that affects absorption, metabolism, or excretion of drugs in the gastrointestinal tract, liver, or kidneys, or have a history of previous disease or surgery 3) Patients with cardiovascular disease, hypotension, or suspected cardiovascular disease 4) Patients with convulsive diseases such as epilepsy or a history of such diseases 5) Those who are allergic to drugs or have a history of such allergy 6) Persons with a predisposition to allergy who are judged inappropriate by the investigator 7) Patients who have a QTc of 450 msec or more or a QTc interval that cannot be measured on a resting 12-lead ECG at screening or prior to Day 1 administration 8) Patients with risk factors for torsades de pointes. 8) Patients with uncontrolled hypokalemia or hypomagnesemia, history of heart failure, history of clinically significant bradycardia/symptomatic bradycardia, or QT prolongation syndrome, or family history of sudden unexpected death or congenital QT prolongation syndrome. 9) Patients with alcohol or drug dependence or a history of such dependence 10) Patients who participated in a clinical trial and received medication within 16 weeks prior to the administration of the investigational drug (except for patch test within 4 weeks prior to the administration of the investigational drug) 11) Subjects who have had more than 400 mL of whole blood drawn within 12 weeks prior to the administration of the investigational drug, or more than 200 mL of whole blood drawn within 4 weeks prior to the administration of the investigational drug, or who have donated blood components within 2 weeks prior to the administration of the investigational drug. 12) Patients who have tested positive for HBs antigen, HCV antibody, HIV antigen or antibody, or syphilis qualitative test (TP antibody method, RPR method) in the clinical examination conducted at the time of screening. 13) Those who are not willing to use appropriate contraception during the clinical trial. 14) Those who are judged inappropriate to participate in the clinical trial by the investigator, etc., based on the results of investigations, observations, tests, etc. at the time of screening and hospitalization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Evaluation of safety The safety and tolerability of single or repeated doses of MA-5 should be evaluated by subjective symptoms, other findings, physiological tests, and clinical examinations. 2) Evaluation of pharmacokinetics The pharmacokinetics of single or repeated administration of MA-5 should be investigated based on MA-5 concentrations in plasma and urine, pharmacokinetic parameters in plasma, and urinary excretion rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety evaluation Measure and evaluate markers for tubular disorders (NAG, b2-microglobulin, L-FABP, NGAL). 2) Evaluation of pharmacokinetics The concentration of MA-5 enantiomer and metabolites (oxidized form, sulfate conjugate, glucuronide conjugate) in plasma and urine will be measured and evaluated. 3) Exploratory endpoints The following exploratory endpoints of single or repeated administration of MA-5 will be evaluated for the Phase II study. - GDF-15 concentration in blood - Blood lactate/pyruvate concentration - Muscle strength (6-minute walk, grip strength of both upper limbs) | — |
Contacts
Public ContactTaigi Yamazaki
Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics
Outcome results
None listed