Clinical trial

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

ID

Name

263-403-00011

Description

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

Trial arms

Trial start

2022-06-30

Estimated PCD

2022-09-21

Trial end

2022-09-21

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

OPC-61815

Size

18

Primary endpoint

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

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

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

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

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

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

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

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

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

Eligibility criteria

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.).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '8 mg and 16 mg.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

Updated at

2023-10-13

1 organization

1 product

1 indication

Product

Indication

Healthy Adult Male

Organization

Otsuka Beijing Research Institute