PruritusPhase 1NCT02846181
A Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-SK-1405
A Phase 1 study testing [14C]-SK-1405 in people with Pruritus, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 1 site in United Kingdom.
Trial summary
The primary objectives of the study are: To assess the mass balance recovery after a single PO dose of [14C]-SK-1405 To provide plasma, urine and faecal samples for metabolite profiling and structural identification 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
- Pruritus
- What is being tested?
- [14C]-SK-1405
- 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 30.0 kg/m2
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
- Must agree to use an adequate method of contraception
Who cannot join
- 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 been dosed with SK-1405 in the past
- Subjects who are taking, or have taken, antiepileptic and/or antidepressant medication in the 6 months prior to dosing
- Subjects who are taking, or have taken, any prescribed medication in the 28 days prior to dosing, unless judged as not clinically significant by the investigator and sponsor
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- Subjects who are taking, or have taken, any over-the-counter medication (with the exception of up to 2,000 mg/day paracetamol/acetaminophen) in the 7 days prior to dosing, unless judged as not clinically significant by the investigator and sponsor
- Use, during the 28 days prior to dosing, of any medicine or herbal remedy (such as St John's wort) known to induce or inhibit CYP enzymes, unless judged as not clinically significant by the investigator and sponsor
- History of any drug or alcohol abuse in the past 2 years
- History of clinically significant neurological conditions
- A QTcF >450 msec at screening, admission or pre-dose (as confirmed by a repeat ECG)
- 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)
- 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, including AST, ALT or alkaline phosphatase >1.5 × upper limit of normal confirmed by repeat testing 18. Positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <90 mL/min using the Cockcroft-Gault equation
- History of clinically significant psychiatric, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
- History of gastrointestinal surgery (except appendectomy) or any condition that may affect the absorption, distribution, metabolism or excretion of study drug in the opinion of the investigator
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy (including food or drug allergy) requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
- Donation or loss of greater than 400 mL of blood within the 3 months prior to IMP dose
- Subjects who have consumed St John's wort, red wine, Seville oranges, grapefruit or grapefruit juice within 7 days prior to dosing. Subjects must be willing to refrain from consuming such products until the last PK sample
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
The primary objectives of the study are:
- To assess the mass balance recovery after a single PO dose of [14C]-SK-1405
- To provide plasma, urine and faecal samples for metabolite profiling and structural identification
- Conditions
- Pruritus
- Being tested
- [14C]-SK-1405
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-SK-1405Drug
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Not described Receives: Drug: [14C]-SK-1405 |
What is being measured
The primary outcome is the main question the study is designed to answer.
14C radioactivity concentration excreted in urine
Measured: Every day for 14 days
14C radioactivity concentration excreted in faeces
Measured: Every day for 14 days
14C radioactivity concentration in whole blood
Measured: Every day for 14 days
14C radioactivity concentration in plasma
Measured: Every day for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 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 PruritusStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846181
- Sponsor's protocol ID
- MO002A
- Status last verified
- Sep 2016
- First submitted
- 11 Jul 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-SK-1405
- ClinicalTrials.gov ID
- NCT02846181
- Acronym / sponsor ID
- MO002A
- Conditions
- Pruritus
- 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
- 27 Jul 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 assess the mass balance recovery after a single PO dose of [14C]-SK-1405
- To provide plasma, urine and faecal samples for metabolite profiling and structural identification
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Drug: [14C]-SK-1405 |
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 30.0 kg/m2
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
Key exclusion criteria (26 listed)
- 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 been dosed with SK-1405 in the past
- Subjects who are taking, or have taken, antiepileptic and/or antidepressant medication in the 6 months prior to dosing
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-1405 | Drug | Healthy |
Primary outcome
14C radioactivity concentration excreted in urine
Time frame: Every day for 14 days
14C radioactivity concentration excreted in faeces
Time frame: Every day for 14 days
14C radioactivity concentration in whole blood
Time frame: Every day for 14 days
14C radioactivity concentration in plasma
Time frame: Every day for 14 days
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 23 Nov 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]-SK-1405 in people with Pruritus, 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 26 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 23 Nov 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?
14C radioactivity concentration excreted in urine (time frame: Every day for 14 days). 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 23 Nov 2016.