OPC-61815 in Healthy Chinese Male Subjects

Otsuka

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Male

Treatments: Drug: OPC-61815 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05439148

263-403-00011

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 1 patient group

OPC-61815

Experimental group

Description:

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

Treatment:

Drug: OPC-61815 injection