PruritusPhase 1NCT02650076
A Study to Investigate the Receptor Occupancy of SK-1405 in Healthy, Caucasian, Male Subjects
A Phase 1 study testing SK-1405 in people with Pruritus, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 1 site in United Kingdom.
Trial summary
The primary objective is to confirm the target receptor occupancy of SK-1405 and to correlate receptor occupancy with SK-1405 dose and plasma concentration. The secondary objective is to assess the safety and tolerability of SK-1405 in healthy, Caucasian, male subjects. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pruritus
- What is being tested?
- SK-1405
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Apr 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able and willing to provide written informed consent to participate in this study, as confirmed by signing the informed consent document(s).
- Adult Caucasian male aged ≥20 and ≤50 years.
- Body Mass Index (BMI) of ≥ 20 and ≤ 30 kg/m2.
- Height ≤ 190 cm.
- Subject is a non-smoker or has not smoked in the past 6 months.
- Subject is considered to be in good health in the opinion of the investigator.
- Subject's pre-study clinical laboratory findings are within normal range.
- Subject must be willing and able to comply with all protocol requirements.
Who cannot join
- Use of prohibited medications as described in the study protocol.
- Current known or suspected history of drug/solvent abuse.
- Current known or suspected history of alcohol abuse or currently drinks in excess of 21 units per week.
- Subjects who have consumed caffeine containing products within 24 hours prior to baseline PET-CT.
- Any concurrent medical, surgical, or psychiatric condition that may affect the subject's ability to meet all protocol requirements during the study duration and/or any significant illness in the investigator's opinion in the 4 weeks before screening.
- Participation in any other clinical study with an investigational drug/device within three months prior to the first day of dosing and after enrolment in the current study.
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- Subject has a positive result of HIV screen, hepatitis B screen or hepatitis C screen.
- Subject has had a serious adverse reaction or significant hypersensitivity to any drug.
- Subject has donated 500 mL or more of blood within the three months prior to screening.
- History of neurological conditions.
- Participation in a research study or other radiation exposure which in conjunction with this study would result in additional ionisation radiation exposure exceeding 10 mSv within the last year.
- A contraindication for MRI, including but not limited to, MRI-incompatible pacemakers, recent metallic implants, foreign body in the eye, or other indications as assessed by a standard pre-MRI questionnaire, that preclude the subject undergoing MRI scans.
- Subject has claustrophobia.
- Subjects who have consumed Saint John's wort, red wine, Seville oranges, grapefruit or grapefruit juice within 7 days prior to dosing.
- Subject has a partner who is either pregnant or breastfeeding for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to confirm the target receptor occupancy of SK-1405 and to correlate receptor occupancy with SK-1405 dose and plasma concentration.
The secondary objective is to assess the safety and tolerability of SK-1405 in healthy, Caucasian, male subjects.
- Conditions
- Pruritus
- Being tested
- 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.
SK-1405Drug
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Not described Receives: Drug: SK-1405 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The receptor occupancy of SK-1405 as measured by PET-CT imaging with [11C]-carfentanil
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 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
- Treatment
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
- NCT02650076
- Sponsor's protocol ID
- MO001A
- Status last verified
- Apr 2016
- First submitted
- 5 Jan 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Receptor Occupancy of SK-1405 in Healthy, Caucasian, Male Subjects
- ClinicalTrials.gov ID
- NCT02650076
- Acronym / sponsor ID
- MO001A
- Conditions
- Pruritus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (actual)
- First posted
- 8 Jan 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 objective is to confirm the target receptor occupancy of SK-1405 and to correlate receptor occupancy with SK-1405 dose and plasma concentration.
The secondary objective is to assess the safety and tolerability of SK-1405 in healthy, Caucasian, male subjects.
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Drug: SK-1405 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Able and willing to provide written informed consent to participate in this study, as confirmed by signing the informed consent document(s).
- Adult Caucasian male aged ≥20 and ≤50 years.
- Body Mass Index (BMI) of ≥ 20 and ≤ 30 kg/m2.
- Height ≤ 190 cm.
- Subject is a non-smoker or has not smoked in the past 6 months.
Key exclusion criteria (15 listed)
- Use of prohibited medications as described in the study protocol.
- Current known or suspected history of drug/solvent abuse.
- Current known or suspected history of alcohol abuse or currently drinks in excess of 21 units per week.
- Subjects who have consumed caffeine containing products within 24 hours prior to baseline PET-CT.
- Any concurrent medical, surgical, or psychiatric condition that may affect the subject's ability to meet all protocol requirements during the study duration and/or any significant illness in the investigator's opinion in the 4 weeks before screening.
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 |
|---|---|---|
| SK-1405 | Drug | Healthy |
Primary outcome
The receptor occupancy of SK-1405 as measured by PET-CT imaging with [11C]-carfentanil
Time frame: up to 4 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 12 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 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 8 inclusion and 15 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 12 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?
The receptor occupancy of SK-1405 as measured by PET-CT imaging with [11C]-carfentanil (time frame: up to 4 days). 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 12 Apr 2016.