OPC-61815 in Healthy Chinese Male Subjects

Phase 1

Completed

• Conditions: Healthy Adult Male
• Interventions: Drug: OPC-61815 injection

• Registration Number: NCT05439148
• Lead Sponsor: Otsuka Beijing Research Institute

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.

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-06-27
• Study Start: 2022-06-30
• Study First Posted: 2022-06-30
• Primary Completion: 2022-09-21
• Study Completion: 2022-09-21
• Status Verified: 2023-02
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
OPC-61815	OPC-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

Primary Outcome Measures

Name	Time	Method
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
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：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

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Clinical Pharmacology Research Center, Peking Union Medical College Hospital; 🇨🇳 Beijing, China