OPC-61815 in Healthy Chinese Male Subjects

A Phase I, Open-label, Single- and Multi-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacological Effect of OPC-61815 in Healthy Chinese Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05439148

Enrollment

Registered

2022-06-30

Start date

2022-06-30

Completion date

2022-09-21

Last updated

2023-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Male

Brief summary

To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of OPC-61815 in healthy Chinese Male subjects

Detailed description

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.

Interventions

DRUGOPC-61815 injection

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.

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

8 mg and 16 mg.

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male subjects aged 18-45 years (including the cutoff values, subject to the time of signing the Informed Consent Form (ICF)); * Body mass index (BMI) of 19-26 kg/m2 (including the cutoff values), with a body weight of not less than 50 kg for male subjects;

Exclusion criteria

* Those whose the sitting pulse is lower than 50 beats/min or higher than 100 beats/min after resting for over 3 minutes. * Those whose sitting SBP is lower than 90 mmHg or higher than 140 mmHg, or DBP is lower than 50 mmHg or higher than 90 mmHg after resting for over 3 minutes. * Various micturition disorders (pollakiuria or dysuria, etc.).

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the pharmacokinetic (PK) characteristics：Vz (OPC-61815 free form only)	before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8	Pharmacokinetic parameters of OPC-61815 free form in plasma after intravenous administration of OPC-61815
To evaluate the pharmacokinetic (PK) characteristics：Rac(AUC0-24h)	before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8	Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815
To evaluate the pharmacokinetic (PK) characteristics：CL (OPC-61815 free form only)	before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8	Pharmacokinetic parameters of OPC-61815 free form in plasma after intravenous administration of OPC-61815
To evaluate the pharmacokinetic (PK) characteristics：Tmax	before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8	Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815
To evaluate the pharmacokinetic (PK) characteristics：Cmax	before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8	Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815
To evaluate the pharmacokinetic (PK) characteristics：AUC0-t, AUC0-inf, AUC0-24h	before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8	Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815
To evaluate the pharmacokinetic (PK) characteristics：t1/2	before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8	Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815
To evaluate the pharmacokinetic (PK) characteristics：λz	before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8	Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815
To evaluate the pharmacokinetic (PK) characteristics：Rac(Cmax)	before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8	Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815

Secondary

Measure	Time frame	Description
To evaluate the safety of single and multiple intravenous administration：adverse events	from screening period to follow up period,assessed up to 16 Days.	adverse events start date, end date , seriousness, severity, relationship to trial treatment (IMP causality), action taken with trial treatment, and outcome will be collect
To evaluate the safety of single and multiple intravenous administration：laboratory tests	from screening period to follow up period,assessed up to 16 Days.	laboratory tests assessment variables include blood routine, blood biochemistry and urine routine.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026