OPC-61815 in Healthy Chinese Male Subjects

Healthy Adult Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05439148
• Other study ID #: 263-403-00011
• Status: Completed
• Phase: Phase 1
• Start date: June 30, 2022
• Est. completion date: September 21, 2022

Study information

• Verified date: February 2023
• Source: Otsuka Beijing Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 21, 2022
• Est. primary completion date: September 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Healthy Adult Male

Intervention

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.

Locations

Country	Name	City	State
China	Clinical Pharmacology Research Center, Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Beijing Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	To evaluate the pharmacokinetic (PK) characteristics:?z	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
Primary	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
Primary	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
Primary	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
Primary	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	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.
Secondary	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.