Healthy Adult Male Participants
Conditions
Interventions
investigational material(s)
Generic name etc : SCO-792
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigatio
Sponsors
SCOHIA PHARMA, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: # The participant is aged 20 to 45 years, inclusive, at the time of informed consent. # The participant weights at least 50 kg and has a body mass index between 18.5 and 25.0 kg/m2 for Japanese.
Exclusion criteria
Exclusion criteria: # The participant has received any investigational compound within 16 weeks (112 days) prior to the dose of randomized study drug. # The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants who experience at least 1 treatment-emergent adverse event An adverse event is defined as any untoward or unintended sign, symptom, or illness that occurs with administration of a study drug regardless of whether it is causally related to the study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC(0-tlqc), Tmax, Cmax for SCO-792 AUC(0-tlqc): Area under the plasma concentration-time curve from Time 0 to Time of the Last Quantifiable Concentration Tmax: Time to reach the maximum plasma concentration Cmax: Maximum observed plasma concentration | — |
Outcome results
None listed