Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of OPC-61815 in healthy Chinese Male subjects
To evaluate the pharmacokinetic (PK) characteristics of single and multiple intravenous administration of OPC-61815 in healthy Chinese subjects.
To evaluate the safety of single and multiple intravenous administration of OPC-61815 in healthy Chinese subjects.
To evaluate the pharmacological effect of single and multiple intravenous administration of OPC-61815 in healthy Chinese subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-61815 | Experimental | Intravenous administration of OPC-61815 at 8 mg or 16 mg. 8mg group will be intravenously administered only on D1, once a day. 16mg group will be intravenously administered on D1，D3-D9, once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-61815 injection | Drug | Intravenous administration of OPC-61815 at 8 mg or 16 mg. 8mg group will be intravenously administered only on D1, once a day. 16mg group will be intravenously administered on D1，D3-D9, once a day. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetic (PK) characteristics：Tmax | Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815 | before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8 |
| To evaluate the pharmacokinetic (PK) characteristics：Cmax | Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815 | before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8 |
| To evaluate the pharmacokinetic (PK) characteristics：AUC0-t, AUC0-inf, AUC0-24h | Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815 | before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8 |
| To evaluate the pharmacokinetic (PK) characteristics：t1/2 | Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815 | before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8 |
| To evaluate the pharmacokinetic (PK) characteristics：λz | Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815 | before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of single and multiple intravenous administration：laboratory tests | laboratory tests assessment variables include blood routine, blood biochemistry and urine routine. | from screening period to follow up period,assessed up to 16 Days. |
| To evaluate the safety of single and multiple intravenous administration：adverse events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hongyun Wang | Peking Union Medical College Hospital | Principal Investigator |
| Hongzhong Liu | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Research Center, Peking Union Medical College Hospital | Beijing | China |
Not provided
8 mg and 16 mg.
Not provided
Not provided
Not provided
Not provided
| To evaluate the pharmacokinetic (PK) characteristics：Rac(Cmax) | Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815 | before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8 |
| To evaluate the pharmacokinetic (PK) characteristics：Rac(AUC0-24h) | Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815 | before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8 |
| To evaluate the pharmacokinetic (PK) characteristics：CL (OPC-61815 free form only) | Pharmacokinetic parameters of OPC-61815 free form in plasma after intravenous administration of OPC-61815 | before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8 |
| To evaluate the pharmacokinetic (PK) characteristics：Vz (OPC-61815 free form only) | Pharmacokinetic parameters of OPC-61815 free form in plasma after intravenous administration of OPC-61815 | before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8 |
adverse events start date, end date , seriousness, severity, relationship to trial treatment (IMP causality), action taken with trial treatment, and outcome will be collect |
| from screening period to follow up period,assessed up to 16 Days. |