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Completed

NCT Number: NCT05439148

OPC-61815 in Healthy Chinese Male Subjects

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

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Key information

Conditions

Healthy Adult Male

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Research Center, Peking Union Medical College Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

OPC-61815 injection

Drug

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.

Primary outcomes

  1. To evaluate the pharmacokinetic (PK) characteristics：Tmax

    Time frame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8

    Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815

  2. To evaluate the pharmacokinetic (PK) characteristics：Cmax

    Time frame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8

    Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815

  3. To evaluate the pharmacokinetic (PK) characteristics：AUC0-t, AUC0-inf, AUC0-24h

    Time frame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8

    Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815

  4. To evaluate the pharmacokinetic (PK) characteristics：t1/2

    Time frame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8

    Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815

  5. To evaluate the pharmacokinetic (PK) characteristics：λz

    Time frame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8

    Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815

  6. To evaluate the pharmacokinetic (PK) characteristics：Rac(Cmax)

    Time frame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8

    Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815

  7. To evaluate the pharmacokinetic (PK) characteristics：Rac(AUC0-24h)

    Time frame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8

    Pharmacokinetic parameters of OPC-61815 free form and metabolites tolvaptan, DM4103 and DM4107 in plasma after intravenous administration of OPC-61815

  8. To evaluate the pharmacokinetic (PK) characteristics：CL (OPC-61815 free form only)

    Time frame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8

    Pharmacokinetic parameters of OPC-61815 free form in plasma after intravenous administration of OPC-61815

  9. To evaluate the pharmacokinetic (PK) characteristics：Vz (OPC-61815 free form only)

    Time frame: before dosing and after the start of dosing on Day1 and Day9(16mg group only); 16mg group also need collect on Day7 and Day8

    Pharmacokinetic parameters of OPC-61815 free form in plasma after intravenous administration of OPC-61815

Secondary outcomes

  1. To evaluate the safety of single and multiple intravenous administration：laboratory tests

    Time frame: from screening period to follow up period,assessed up to 16 Days.

    laboratory tests assessment variables include blood routine, blood biochemistry and urine routine.

  2. To evaluate the safety of single and multiple intravenous administration：adverse events

    Time frame: from screening period to follow up period,assessed up to 16 Days.

    adverse events start date, end date , seriousness, severity, relationship to trial treatment (IMP causality), action taken with trial treatment, and outcome will be collect

Sponsors and collaborators

Lead sponsor

Otsuka Beijing Research Institute

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2022
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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