Healthy Adult MalePhase 1NCT04182958
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects
A Phase 1 study testing (14C)-OPC-61815 in people with Healthy Adult Male, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in United Kingdom.
Trial summary
To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815. To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815 To assess the PK of total radioactivity in plasma and whole blood following a single IV infusion of… Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- (14C)-OPC-61815
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2019to 19 Dec 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects between 35 and 55 years of age, inclusive; hold a valid Japanese passport and be first generation Japanese, defined as the subject, the subject's biological parent, and all of the subject's biological grandparents being of exclusive Japanese descent, have been born in Japan, and not lived outside of Japan for more than 5 years; with a body mass index between 18.5 and 28.0 kg/m2, inclusive, and a total body weight between 50 and 100 kg, inclusive; in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations at Screening and Check in as assessed by the investigator (or designee); and have a history of a minimum of 1 bowel movement per day.
Who cannot join
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion; poor peripheral venous access; participation in a clinical trial involving administration of an investigational drug in the past 90 days prior to dosing; subjects with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in; subjects who have participated in any clinical trial involving a radiolabeled investigational drug within 12 months prior to Check-in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label Trial to Assess the Mass Balance and Pharmacokinetics of a Single Intravenous Administration of (14C)-OPC-61815 to Healthy Male Japanese Subjects
- To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815.
- To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815
- To assess the PK of total radioactivity in plasma and whole blood following a single IV infusion of (14C)-OPC-61815
- To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV infusion of (14C)-OPC-61815
- Conditions
- Healthy Adult Male
- Being tested
- (14C)-OPC-61815
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(14C)-OPC-61815Drug
On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815
| Study group | Role | What they receive |
|---|---|---|
| (14C)-OPC-61815 | Experimental | Not described Receives: Drug: (14C)-OPC-61815 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form
Measured: 48 hours after dose
Maximum Peak Concentration (Cmax) - Plasma OPC-61815 Free Form
Measured: 48 hours after dose
Terminal-phase Elimination Half-life (t1/2,z) - Plasma OPC-61815 Free Form
Measured: 48 hours after dose
AUC∞ - Plasma OPC-41061
Measured: 48 hours after dose
Cmax - Plasma OPC-41061
Measured: 48 hours after dose
t1/2,z - Plasma OPC-41061
Measured: 48 hours after dose
AUC∞ - Plasma Total Radioactivity
Measured: 168 hours after dose
Cmax - Plasma Total Radioactivity
Measured: 168 hours after dose
t1/2,z - Plasma Total Radioactivity
Measured: 168 hours after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start25 Nov 2019
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takehisa Matsumaru, Mr, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182958
- Sponsor's protocol ID
- 263-102-00006
- Other IDs
- 2019-001968-29, 2019
- Status last verified
- Sep 2021
- First submitted
- 27 Nov 2019
- Last updated
- 6 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Trial to Assess the Mass Balance and Pharmacokinetics of a Single Intravenous Administration of (14C)-OPC-61815 to Healthy Male Japanese Subjects
- ClinicalTrials.gov ID
- NCT04182958
- Acronym / sponsor ID
- 263-102-00006
- Conditions
- Healthy Adult Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Posted 6 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815.
- To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815
- To assess the PK of total radioactivity in plasma and whole blood following a single IV infusion of (14C)-OPC-61815
- To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV infusion of (14C)-OPC-61815
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (14C)-OPC-61815 | Experimental | Drug: (14C)-OPC-61815 |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male subjects between 35 and 55 years of age, inclusive; hold a valid Japanese passport and be first generation Japanese, defined as the subject, the subject's biological parent, and all of the subject's biological grandparents being of exclusive Japanese descent, have been born in Japan, and not lived outside of Japan for more than 5 years; with a body mass index between 18.5 and 28.0 kg/m2, inclusive, and a total body weight between 50 and 100 kg, inclusive; in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations at Screening and Check in as assessed by the investigator (or designee); and have a history of a minimum of 1 bowel movement per day.
Key exclusion criteria (1 listed)
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion; poor peripheral venous access; participation in a clinical trial involving administration of an investigational drug in the past 90 days prior to dosing; subjects with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in; subjects who have participated in any clinical trial involving a radiolabeled investigational drug within 12 months prior to Check-in.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (14C)-OPC-61815On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815 | Drug | (14C)-OPC-61815 |
Primary outcome
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form
Time frame: 48 hours after dose
Maximum Peak Concentration (Cmax) - Plasma OPC-61815 Free Form
Time frame: 48 hours after dose
Terminal-phase Elimination Half-life (t1/2,z) - Plasma OPC-61815 Free Form
Time frame: 48 hours after dose
AUC∞ - Plasma OPC-41061
Time frame: 48 hours after dose
Cmax - Plasma OPC-41061
Time frame: 48 hours after dose
t1/2,z - Plasma OPC-41061
Time frame: 48 hours after dose
AUC∞ - Plasma Total Radioactivity
Time frame: 168 hours after dose
Cmax - Plasma Total Radioactivity
Time frame: 168 hours after dose
t1/2,z - Plasma Total Radioactivity
Time frame: 168 hours after dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Small studies with less than 25 participants are excluded from data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takehisa Matsumaru, Mr study director
Otsuka Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing (14C)-OPC-61815 in people with Healthy Adult Male, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form (time frame: 48 hours after dose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.