Phase 1
Completed N=8
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects
Healthy Adult Male
Source: ClinicalTrials.gov NCT04182958 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form — 2060 h*ng/mL
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 (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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form |
2060 | — |
| PRIMARY Maximum Peak Concentration (Cmax) - Plasma OPC-61815 Free Form |
1500 | — |
| PRIMARY Terminal-phase Elimination Half-life (t1/2,z) - Plasma OPC-61815 Free Form |
3.61 | — |
| PRIMARY AUC∞ - Plasma OPC-41061 |
1150 | — |
| PRIMARY Cmax - Plasma OPC-41061 |
204 | — |
| PRIMARY t1/2,z - Plasma OPC-41061 |
5.27 | — |
| PRIMARY AUC∞ - Plasma Total Radioactivity |
30300 | — |
| PRIMARY Cmax - Plasma Total Radioactivity |
2180 | — |
| PRIMARY t1/2,z - Plasma Total Radioactivity |
128 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04182958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.