NCT05439148

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2022

Completed
Last Updated

October 13, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

April 18, 2022

Last Update Submit

October 11, 2023

Conditions

Healthy Adult Male

Outcome Measures

Primary Outcomes (9)

  • To evaluate the pharmacokinetic (PK) characteristics：Tmax

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

    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

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

    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

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

    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

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

    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

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

    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)

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

    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)

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

    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)

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

    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)

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

    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 (2)

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

    from screening period to follow up period,assessed up to 16 Days.

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

    from screening period to follow up period,assessed up to 16 Days.

Study Arms (1)

OPC-61815

EXPERIMENTAL

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

Drug: OPC-61815 injection

Interventions

OPC-61815 injectionDRUG

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.

OPC-61815

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology Research Center, Peking Union Medical College Hospital

Beijing, China

Location

Study Officials

  • Hongyun Wang

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

  • Hongzhong Liu

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 8 mg and 16 mg.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2022

First Posted

June 30, 2022

Study Start

June 30, 2022

Primary Completion

September 21, 2022

Study Completion

September 21, 2022

Last Updated

October 13, 2023

Record last verified: 2023-02

Locations

CN(1)