A Phase 1 interventional study of 14C-OPS-2071 in Bacterial Enteritis, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 1 site in United Kingdom. Open to male participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-21.
Sponsored by Otsuka Pharmaceutical Co., Ltd. (part of Otsuka Holdings Co., Ltd.) · Phase 1, Interventional, and Treatment
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
34 studies on the registry are indexed under Enteritis; 7 are open to participants now.
This study's enrollment of 8 is below the median of 53 across 26 interventional studies indexed under Enteritis.
Browse Enteritis studies →Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 143 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Suspension containing 50 mg of 14C-OPS-2071
Drug: 14C-OPS-2071
Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.
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.
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.
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.
| Milestone | 14C-OPS-2071 |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
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.
| percentage of administered dose | Feces | Urine | Total |
|---|---|---|---|
| The Amounts of Radioactivity Excreted in Urine and Faeces | 78.0 ± 13.1 | 6.08 ± 1.71 | 84.1 ± 12.7 |
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.
| μg eq.·h/L | Plasma | Whole Blood |
|---|---|---|
| Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood | 649.0 ± 486.0 | 411.0 ± 73.9 |
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.
| μg·h/L | Plasma |
|---|---|
| AUC of OPS-2071 in Plasma | 392.0 ± 95.8 |
Collected over From informed Consent up to 22 days post dose. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 14C-OPS-2071 | — | 0/8 (0%) | 4/8 (50%) |
| Event | 14C-OPS-2071 |
|---|---|
| DiarrhoeaGastrointestinal disorders | 2/8 |
| DyspepsiaGastrointestinal disorders | 1/8 |
| GastroenteritisInfections and infestations | 1/8 |
| NasopharyngitisInfections and infestations | 1/8 |
| Alanine aminotransferase increaseInvestigations | 1/8 |
| HeadacheNervous system disorders | 1/8 |
| Arthropod biteInjury, poisoning and procedural complications | 1/8 |
| Age, Categorical(Participants) | 14C-OPS-2071 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Age, Continuous(years) | 14C-OPS-2071 |
|---|---|
| Mean | 42.0 ± 4.8 |
| Sex: Female, Male(Participants) | 14C-OPS-2071 |
|---|---|
| Female | 0 |
| Male | 8 |
| Region of Enrollment(participants) | 14C-OPS-2071 |
|---|---|
| United Kingdom | 8 |
The record gives a start of May 2015, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2016, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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