Trial Outcomes & Findings for A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects (NCT NCT04182958)

NCT ID: NCT04182958

Last Updated: 2021-10-06

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

48 hours after dose

Results posted on

2021-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Overall: (14C)-OPC-61815 Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall: (14C)-OPC-61815 n=8 Participants Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
Age, Continuous	43 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	8 Participants n=5 Participants
Region of Enrollment United Kingdom	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours after dose

Population: The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.

Outcome measures

Outcome measures
Measure	Overall: (14C)-OPC-61815 n=8 Participants Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form	2060 h*ng/mL Standard Deviation 305

PRIMARY outcome

Timeframe: 48 hours after dose

Population: The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.

Outcome measures

Outcome measures
Measure	Overall: (14C)-OPC-61815 n=8 Participants Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
Maximum Peak Concentration (Cmax) - Plasma OPC-61815 Free Form	1500 ng/mL Standard Deviation 156

PRIMARY outcome

Timeframe: 48 hours after dose

Population: The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.

Outcome measures

Outcome measures
Measure	Overall: (14C)-OPC-61815 n=8 Participants Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
Terminal-phase Elimination Half-life (t1/2,z) - Plasma OPC-61815 Free Form	3.61 hours Standard Deviation 1.34

PRIMARY outcome

Timeframe: 48 hours after dose

Population: The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.

Outcome measures

Outcome measures
Measure	Overall: (14C)-OPC-61815 n=8 Participants Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
AUC∞ - Plasma OPC-41061	1150 h*ng/mL Standard Deviation 230

PRIMARY outcome

Timeframe: 48 hours after dose

Population: The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.

Outcome measures

Outcome measures
Measure	Overall: (14C)-OPC-61815 n=8 Participants Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
Cmax - Plasma OPC-41061	204 ng/mL Standard Deviation 27.9

PRIMARY outcome

Timeframe: 48 hours after dose

Population: The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.

Outcome measures

Outcome measures
Measure	Overall: (14C)-OPC-61815 n=8 Participants Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
t1/2,z - Plasma OPC-41061	5.27 hours Standard Deviation 0.826

PRIMARY outcome

Timeframe: 168 hours after dose

Population: The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.

Outcome measures

Outcome measures
Measure	Overall: (14C)-OPC-61815 n=8 Participants Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
AUC∞ - Plasma Total Radioactivity	30300 h*ngEq/mL Standard Deviation 4850

PRIMARY outcome

Timeframe: 168 hours after dose

Population: The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.

Outcome measures

Outcome measures
Measure	Overall: (14C)-OPC-61815 n=8 Participants Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
Cmax - Plasma Total Radioactivity	2180 ngEq/mL Standard Deviation 188

PRIMARY outcome

Timeframe: 168 hours after dose

Population: The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.

Outcome measures

Outcome measures
Measure	Overall: (14C)-OPC-61815 n=8 Participants Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
t1/2,z - Plasma Total Radioactivity	128 hours Standard Deviation 33.1

Adverse Events

Overall: (14C)-OPC-61815

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Overall: (14C)-OPC-61815 n=8 participants at risk Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of investigational medicinal product (IMP) administration up to 12 days The safety population included all subjects that received (14C)-OPC-61815.

Additional Information

Director of Clinical Trials

Otsuka Pharmaceutical Co., LTD.

Phone: +81-3-6361-7366

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place