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OPC-61815 in Healthy Chinese Male Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT05439148•Otsuka Beijing Research Institute

View on ClinicalTrials.gov

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

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

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.).

Locations (1)

Clinical Pharmacology Research Center, Peking Union Medical College Hospital

Beijing, China

Key Dates

Start Date

June 30, 2022

Primary Completion Date

September 21, 2022

Completion Date

September 21, 2022

Last Updated

October 13, 2023

Enrollment

ACTUAL participants

Conditions

Healthy Adult Male

Interventions

OPC-61815 injection

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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OPC-61815 in Healthy Chinese Male Subjects

Inclusion Criteria

Exclusion Criteria

Evaluation of MTX-463 Administered Subcutaneously in Healthy Adult Males

Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions

Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects

Study to Evaluate the Drug-drug Interaction Between IY001 and IY002 in Healthy Adult Male Subjects.

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