Bacterial Enteritis
Conditions
Brief summary
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
Interventions
DRUG14C-OPS-2071
Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Amounts of Radioactivity Excreted in Urine and Faeces | up to144-168h postdose. | A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose. |
| Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood | predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose. | A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites. |
| AUC of OPS-2071 in Plasma | predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose. | A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 14C-OPS-2071 Suspension containing 50 mg of 14C-OPS-2071
14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | 14C-OPS-2071 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 42.0 years STANDARD_DEVIATION 4.8 |
| Region of Enrollment United Kingdom | 8 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood
A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites.
Time frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feces | Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood | 649.0 μg eq.·h/L | Standard Deviation 486 |
| Urine | Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood | 411.0 μg eq.·h/L | Standard Deviation 73.9 |
Primary
AUC of OPS-2071 in Plasma
A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma.
Time frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feces | AUC of OPS-2071 in Plasma | 392.0 μg·h/L | Standard Deviation 95.8 |
Primary
The Amounts of Radioactivity Excreted in Urine and Faeces
A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose.
Time frame: up to144-168h postdose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feces | The Amounts of Radioactivity Excreted in Urine and Faeces | 78.0 percentage of administered dose | Standard Deviation 13.1 |
| Urine | The Amounts of Radioactivity Excreted in Urine and Faeces | 6.08 percentage of administered dose | Standard Deviation 1.71 |
| Total | The Amounts of Radioactivity Excreted in Urine and Faeces | 84.1 percentage of administered dose | Standard Deviation 12.7 |