Phase 1
N=8
A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects
Bacterial Enteritis
Bottom Line
View on ClinicalTrials.gov: NCT02440633 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: The Amounts of Radioactivity Excreted in Urine and Faeces — 78.0; 6.08; 84.1 percentage of administered dose
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 14C-OPS-2071 (Drug)
- Age
- Adult · 35+ yrs
- Sex
- Male
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Amounts of Radioactivity Excreted in Urine and Faeces |
78.0; 6.08; 84.1 | — |
| PRIMARY Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood |
649.0; 411.0 | — |
| PRIMARY AUC of OPS-2071 in Plasma |
392.0 | — |
Summary
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
Eligibility Criteria
Inclusion Criteria
- Healthy males
- Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Exclusion Criteria
- Subjects who have a significant history of alcoholism or drug/chemical abuse, as determined by the Investigator.
- Subjects who smoke, or who have used nicotine within 3 months prior to screening..
- Subjects who have a significant history of drug allergy, as determined by the Investigator.
- Subjects who have any clinically significant abnormal physical examination finding.
- Subjects who have any clinically significant medical history, as determined by the Investigator.
- Subjects who are exposed to radiation as a result of their occupation.
- Subjects who have had an X ray or CT scan, or who have participated in any trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.
Data sourced from ClinicalTrials.gov (NCT02440633). 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.