NocturiaPhase 1NCT02878096
Bioavailability of [14C]-SK-1404 ADME & IV Microtracer Study
A Phase 1 study testing [14C]-SK-1404 in people with Nocturia, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 1 site in United Kingdom.
Trial summary
The primary objectives of the study are: To determine the absolute bioavailability of SK-1404 To assess the mass balance recovery after a single oral (PO) dose of carbon-14 (14C)-SK-1404 To provide plasma, urine and faecal samples for metabolite profiling and structural identification The secondary objectives of the… Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nocturia
- What is being tested?
- [14C]-SK-1404
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Aug 2016
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
- Age 30 to 65 years of age
- Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
- Must agree to use an adequate method of contraception
Who cannot join
- Males with pregnant partners
- Participation in a clinical research study within the 3 months prior to IMP dose
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study
- Subjects who have previously been dosed with SK-1404
- History of any drug or alcohol abuse in the past 2 years
Show all 14Show fewer
- Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine) in the past year
- Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products. A breath carbon monoxide reading of greater than 10 ppm at screening or admission
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
- Subjects who have been enrolled in an ADME study in the last 12 months
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1)
- Aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase >1.5 × upper limit of normal confirmed by repeat testing
- Serum sodium below the lower limit of normal
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Ruddington, Nottingham, NG11 6JS
About this study
Official title: An Open-Label, 2-Part Sequential Dose Study Designed to Assess the Absolute Bioavailability, Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-SK-1404 Administered to Healthy Male Subjects
The primary objectives of the study are:
- To determine the absolute bioavailability of SK-1404
- To assess the mass balance recovery after a single oral (PO) dose of carbon-14 (14C)-SK-1404
- To provide plasma, urine and faecal samples for metabolite profiling and structural identification
Read more
The secondary objectives of the study are:
- To determine the routes and rates of elimination of [14C]-SK-1404
- To identify the chemical structure of each metabolite with an exposure (AUC) of more than 10% of circulating total radioactivity
- To explore the intravenous (IV) pharmacokinetics (PK) of [14C]-SK-1404
- To further explore the PO PK of SK-1404
- To provide additional safety and tolerability information for SK-1404
Read the detailed description
This is a single-centre, 2-part, open-label, non-randomised, sequential, single dose study in healthy male subjects. It is planned to enrol a single cohort of 6 healthy male subjects who will participate in Parts 1 and Part 2 of the study.
In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of [14C]-SK-1404.
In Part 2, each subject will receive a single PO dose of [14C]-SK-1404.
- Conditions
- Nocturia
- Being tested
- [14C]-SK-1404
- Keywords
- nocturnal polyuria
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-SK-1404Drug
In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of [14C]-SK-1404.
| Study group | Role | What they receive |
|---|---|---|
| [14C]-SK-1404 | Experimental | Not described Receives: Drug: [14C]-SK-1404 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability (F) calculated with the AUC values of IV administration in Part 1 and PO administration in Part 2
Measured: Predose to 96hr
Mass balance recovery of total radioactivity in urine, faeces and all excreta
Amount excreted (Ae), and Ae as a percentage of the administered dose (%Ae), cumulative recovery (Cum Ae) and cumulative recovery expressed as a percentage of the dose (Cum %Ae)
Measured: Predose to 168hr
Number and structural identification of known and unknown metabolites of SK-1404 in the plasma, urine and faeces samples
Measured: Predose to 168hr
Secondary outcomes (32)
Ae total radioactivity in plasma by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
Measured: Predose to 168hr
%Ae total radioactivity in plasma by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
Measured: Predose to 168hr
Cum Ae (total) for urine by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
Measured: Predose to 168hr
Cum %Ae (total) for urine by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
Measured: Predose to 168hr
Cum Ae (total) for faeces by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
Measured: Predose to 168hr
Cum %Ae (total) for faeces by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
Measured: Predose to 168hr
Number and structural identification of unknown metabolites of SK-1404 with an AUC of more than 10% of circulating total radioactivity
Measured: Predose to 168hr
The peak plasma concentration (Cmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 96hr
The time from dosing at which Cmax was apparent (Tmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 96hr
The elapsed time from dosing at which the analyte was first quantifiable in a concentration vs time profile (Tlag) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 96hr
The area under the concentration-time curve from dosing to the last measurable concentration (AUC(0-last)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 96hr
The area under the concentration-time curve from dosing extrapolated to infinity (AUC(0-inf)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 96hr
The percentage of AUC(0-inf) extrapolated beyond the last measured time point (AUC%extrap) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 96hr
The terminal elimination rate constant calculated from the slope of the apparent elimination phase (lambda-z) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 96hr
The apparent terminal elimination half-life (T1/2) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 96hr
The apparent total clearance (CL/F) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 96hr
The apparent volume of distribution (Vd) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 96hr
The apparent volume of distribution (Vss) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 96hr
The mean residence time (MRT) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 96hr
The peak plasma concentration (Cmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 168hr
The time from dosing at which Cmax was apparent (Tmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 168hr
The elapsed time from dosing at which the analyte was first quantifiable in a concentration vs time profile (Tlag) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 168hr
The area under the concentration-time curve from dosing to the last measurable concentration (AUC(0-last)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 168hr
The area under the concentration-time curve from dosing extrapolated to infinity (AUC(0-inf)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 168hr
The percentage of AUC(0-inf) extrapolated beyond the last measured time point (AUC%extrap) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 168hr
The terminal elimination rate constant calculated from the slope of the apparent elimination phase (lambda-z) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 168hr
The apparent terminal elimination half-life (T1/2) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 168hr
The absolute bioavailability (F, PO vs IV from Part 1) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 168hr
The apparent total clearance (CL/F) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 168hr
The apparent volume of distribution (Vd/F) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 168hr
The mean residence time (MRT) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
Measured: Predose to 168hr
To collect further information about the safety and tolerability of IMP
By assessing physical examination, safety laboratory tests, vital signs, electrocardiograms (ECGs) and AEs.
Measured: Predose to 168hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Litza McKenzie, MBChB BScMedSci, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878096
- Sponsor's protocol ID
- QCL117764
- Status last verified
- Oct 2016
- First submitted
- 5 Aug 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, 2-Part Sequential Dose Study Designed to Assess the Absolute Bioavailability, Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-SK-1404 Administered to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02878096
- Acronym / sponsor ID
- QCL117764
- Conditions
- Nocturia
- Keywords
- nocturnal polyuria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Aug 2016 (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 primary objectives of the study are:
- To determine the absolute bioavailability of SK-1404
- To assess the mass balance recovery after a single oral (PO) dose of carbon-14 (14C)-SK-1404
- To provide plasma, urine and faecal samples for metabolite profiling and structural identification
The secondary objectives of the study are:
- To determine the routes and rates of elimination of [14C]-SK-1404
- To identify the chemical structure of each metabolite with an exposure (AUC) of more than 10% of circulating total radioactivity
- To explore the intravenous (IV) pharmacokinetics (PK) of [14C]-SK-1404
- To further explore the PO PK of SK-1404
- To provide additional safety and tolerability information for SK-1404
Detailed description
This is a single-centre, 2-part, open-label, non-randomised, sequential, single dose study in healthy male subjects. It is planned to enrol a single cohort of 6 healthy male subjects who will participate in Parts 1 and Part 2 of the study.
In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of [14C]-SK-1404.
In Part 2, each subject will receive a single PO dose of [14C]-SK-1404.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-SK-1404 | Experimental | Drug: [14C]-SK-1404 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy males
- Age 30 to 65 years of age
- Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
Key exclusion criteria (14 listed)
- Males with pregnant partners
- Participation in a clinical research study within the 3 months prior to IMP dose
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study
- Subjects who have previously been dosed with SK-1404
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]-SK-1404In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of [14C]-SK-1404. | Drug | [14C]-SK-1404 |
Primary outcome
Absolute bioavailability (F) calculated with the AUC values of IV administration in Part 1 and PO administration in Part 2
Time frame: Predose to 96hr
Mass balance recovery of total radioactivity in urine, faeces and all excreta
Time frame: Predose to 168hr
Amount excreted (Ae), and Ae as a percentage of the administered dose (%Ae), cumulative recovery (Cum Ae) and cumulative recovery expressed as a percentage of the dose (Cum %Ae)
Number and structural identification of known and unknown metabolites of SK-1404 in the plasma, urine and faeces samples
Time frame: Predose to 168hr
32 secondary outcomes
Ae total radioactivity in plasma by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
Time frame: Predose to 168hr
%Ae total radioactivity in plasma by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
Time frame: Predose to 168hr
Cum Ae (total) for urine by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
Time frame: Predose to 168hr
Cum %Ae (total) for urine by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
Time frame: Predose to 168hr
Cum Ae (total) for faeces by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
Time frame: Predose to 168hr
Cum %Ae (total) for faeces by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
Time frame: Predose to 168hr
Number and structural identification of unknown metabolites of SK-1404 with an AUC of more than 10% of circulating total radioactivity
Time frame: Predose to 168hr
The peak plasma concentration (Cmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Time frame: Predose to 96hr
The time from dosing at which Cmax was apparent (Tmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Time frame: Predose to 96hr
The elapsed time from dosing at which the analyte was first quantifiable in a concentration vs time profile (Tlag) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Time frame: Predose to 96hr
The area under the concentration-time curve from dosing to the last measurable concentration (AUC(0-last)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Time frame: Predose to 96hr
The area under the concentration-time curve from dosing extrapolated to infinity (AUC(0-inf)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Time frame: Predose to 96hr
The percentage of AUC(0-inf) extrapolated beyond the last measured time point (AUC%extrap) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Time frame: Predose to 96hr
The terminal elimination rate constant calculated from the slope of the apparent elimination phase (lambda-z) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Time frame: Predose to 96hr
The apparent terminal elimination half-life (T1/2) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Time frame: Predose to 96hr
The apparent total clearance (CL/F) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Time frame: Predose to 96hr
The apparent volume of distribution (Vd) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Time frame: Predose to 96hr
The apparent volume of distribution (Vss) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Time frame: Predose to 96hr
The mean residence time (MRT) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
Time frame: Predose to 96hr
The peak plasma concentration (Cmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Time frame: Predose to 168hr
The time from dosing at which Cmax was apparent (Tmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Time frame: Predose to 168hr
The elapsed time from dosing at which the analyte was first quantifiable in a concentration vs time profile (Tlag) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Time frame: Predose to 168hr
The area under the concentration-time curve from dosing to the last measurable concentration (AUC(0-last)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Time frame: Predose to 168hr
The area under the concentration-time curve from dosing extrapolated to infinity (AUC(0-inf)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Time frame: Predose to 168hr
The percentage of AUC(0-inf) extrapolated beyond the last measured time point (AUC%extrap) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Time frame: Predose to 168hr
The terminal elimination rate constant calculated from the slope of the apparent elimination phase (lambda-z) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Time frame: Predose to 168hr
The apparent terminal elimination half-life (T1/2) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Time frame: Predose to 168hr
The absolute bioavailability (F, PO vs IV from Part 1) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Time frame: Predose to 168hr
The apparent total clearance (CL/F) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Time frame: Predose to 168hr
The apparent volume of distribution (Vd/F) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Time frame: Predose to 168hr
The mean residence time (MRT) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
Time frame: Predose to 168hr
To collect further information about the safety and tolerability of IMP
Time frame: Predose to 168hr
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 14 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Litza McKenzie, MBChB BScMedSci principal investigator
Quotient Clinical
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]-SK-1404 in people with Nocturia, run by Sanwa Kagaku Kenkyusho 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 7 inclusion and 14 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 14 Oct 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?
Absolute bioavailability (F) calculated with the AUC values of IV administration in Part 1 and PO administration in Part 2 (time frame: Predose to 96hr). The study lists 3 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 14 Oct 2016.