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

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

Study Overview

• Status: Completed
• Conditions: Healthy Adult Male
• Intervention / Treatment: Drug: OPC-61815 injection

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Clinical Pharmacology Research Center, Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPC-61815; 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	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Otsuka Beijing Research Institute
• Investigators: Principal Investigator: Hongzhong Liu, Peking Union Medical College Hospital; Principal Investigator: Hongyun Wang, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): September 21, 2022
• Study Completion (Actual): September 21, 2022

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 263-403-00011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No