Healthy Adult Volunteers
Conditions
Interventions
investigational material(s)
Generic name etc : PCO371
INN of investigational material : -
Therapeutic category code : 243 Thyroid and para-thyroid hormone preparations
Dosage and Administration for In
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Subjects have received a thorough explanation of the clinical study, voluntary consent has been provided by the subject himself, and the subjects are able to comply with the requirements of the protocol - Healthy Japanese male aged between 20 and 45 years at the time of providing informed consent - Subjects have a BMI between 18.5 and 25.0 kg/m2 at screening And so on.
Exclusion criteria
Exclusion criteria: - Current or previous history (in the 3 years prior to the first dose of the IMP or concomitant drug) of renal, hepatic, cardiac, gastrointestinal, immunologic, endocrine, neurologic, metabolic, or respiratory disease or blood dyscrasia; or current renal, hepatic, or cardiopulmonary dysfunction - Any other reason that, in the judgment of the investigator, would render the subject unsuitable for study participation And so on.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety [All cohorts] TEAEs, Change in Vital signs, Laboratory test values and 12-lead electrocardiogram results pharmacokinetics [Cohorts where PCO371 is the interacted drug] Plasma concentrations and PK parameters of PCO371 and metabolites pharmacokinetics [Cohorts where PCO371 is the interacting drug] Plasma concentrations and PK parameters of the concomitant drug (and metabolites) | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics [Cohorts where PCO371 is the interacted drug] Plasma concentrations and PK parameters of the concomitant drug (and metabolites) pharmacodynamics [Some of cohorts where PCO371 is the interacted drug] Pharmacodynamics parameters pharmacokinetics [Cohorts where PCO371 is the interacting drug] Plasma concentrations and PK parameters of PCO371 and metabolites | — |
Countries
Japan
Outcome results
None listed