Clinical trial NCT05439148: OPC-61815 in Healthy Chinese Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Male
Lead sponsor: Otsuka Beijing Research Institute
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 8 mg and 16 mg.
Primary purpose: TREATMENT

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.

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.).

Primary outcomes:
measure: To evaluate the pharmacokinetic (PK) characteristics：Tmax
timeFrame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8
measure: To evaluate the pharmacokinetic (PK) characteristics：Cmax
timeFrame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8
measure: To evaluate the pharmacokinetic (PK) characteristics：AUC0-t, AUC0-inf, AUC0-24h
timeFrame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8
measure: To evaluate the pharmacokinetic (PK) characteristics：t1/2
timeFrame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8
measure: To evaluate the pharmacokinetic (PK) characteristics：λz
timeFrame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8
measure: To evaluate the pharmacokinetic (PK) characteristics：Rac(Cmax)
timeFrame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8
measure: To evaluate the pharmacokinetic (PK) characteristics：Rac(AUC0-24h)
timeFrame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8
measure: To evaluate the pharmacokinetic (PK) characteristics：CL (OPC-61815 free form only)
timeFrame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8
measure: To evaluate the pharmacokinetic (PK) characteristics：Vz (OPC-61815 free form only)
timeFrame: 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 outcomes:
measure: To evaluate the safety of single and multiple intravenous administration：laboratory tests
timeFrame: from screening period to follow up period,assessed up to 16 Days.
measure: To evaluate the safety of single and multiple intravenous administration：adverse events
timeFrame: from screening period to follow up period,assessed up to 16 Days.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Clinical Pharmacology Research Center, Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Hongyun Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Hongzhong Liu
role: PRINCIPAL_INVESTIGATOR
References: