Healthy Male SubjectPhase 1NCT02434835
Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male Subjects
A Phase 1 study testing [14C]KWA-0711 in people with Healthy Male Subject, run by Kissei Pharmaceutical Co., Ltd. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the absorption, metabolism and excretion following a single oral dose of [14C]KWA-0711 to healthy male subjects. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men only
- Conditions the study is for
- Healthy Male Subject
- What is being tested?
- [14C]KWA-0711
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento May 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Adult
Who may be able to join
- Subjects who are male, caucasian, and between 35 and 55 years of age, inclusive.
- Subjects who have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive.
- Subjects who have a body weight between 50 and 100 kg, inclusive.
- Subjects must have regular bowel movements.
Who cannot join
- Subjects who have an abnormality in heart rate, blood pressure , temperature or 12-lead ECG.
- Subjects who are still participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug in the 3 months prior to dose administration.
- Subjects who have had a clinically significant illness within 4 weeks of dose administration as determined by the Investigator.
- Subjects who have any clinically significant abnormal laboratory safety findings.
- Subjects who have had an X ray or who have participated in any clinical trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the absorption, metabolism and excretion following a single oral dose of [14C]KWA-0711 to healthy male subjects.
- Conditions
- Healthy Male Subject
- Being tested
- [14C]KWA-0711
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]KWA-0711Drug
| Study group | Role | What they receive |
|---|---|---|
| [14C]KWA-0711 | Experimental | Not described Receives: Drug: [14C]KWA-0711 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites
Measured: 240 hours
Maximum observed plasma concentration (Cmax) of total radioactivity, unchanged drug substance and its major metabolites
Measured: 240 hours
Cumulative radioactivity recovery in urine and feces
Measured: 240 hours
Profiles of metabolites in plasma, urine and faeces
Measured: 240 hours
Secondary outcomes (1)
Number of adverse events
Measured: 240 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Primary completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectStudies 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
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434835
- Sponsor's protocol ID
- KWA1101
- Status last verified
- Apr 2016
- First submitted
- 21 Apr 2015
- Last updated
- 18 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02434835
- Acronym / sponsor ID
- KWA1101
- Conditions
- Healthy Male Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Primary completion
- May 2015 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the absorption, metabolism and excretion following a single oral dose of [14C]KWA-0711 to healthy male subjects.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]KWA-0711 | Experimental | Drug: [14C]KWA-0711 |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who are male, caucasian, and between 35 and 55 years of age, inclusive.
- Subjects who have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive.
- Subjects who have a body weight between 50 and 100 kg, inclusive.
- Subjects must have regular bowel movements.
Key exclusion criteria (5 listed)
- Subjects who have an abnormality in heart rate, blood pressure , temperature or 12-lead ECG.
- Subjects who are still participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug in the 3 months prior to dose administration.
- Subjects who have had a clinically significant illness within 4 weeks of dose administration as determined by the Investigator.
- Subjects who have any clinically significant abnormal laboratory safety findings.
- Subjects who have had an X ray or who have participated in any clinical trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.
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]KWA-0711 | Drug | [14C]KWA-0711 |
Primary outcome
Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites
Time frame: 240 hours
Maximum observed plasma concentration (Cmax) of total radioactivity, unchanged drug substance and its major metabolites
Time frame: 240 hours
Cumulative radioactivity recovery in urine and feces
Time frame: 240 hours
Profiles of metabolites in plasma, urine and faeces
Time frame: 240 hours
1 secondary outcome
Number of adverse events
Time frame: 240 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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]KWA-0711 in people with Healthy Male Subject, run by Kissei 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 4 inclusion and 5 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 18 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites (time frame: 240 hours). The study lists 4 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 18 Apr 2016.