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A Study to Investigate the Receptor Occupancy of SK-1405 in Healthy, Caucasian, Male Subjects

Primary Purpose

Pruritus

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
SK-1405
Sponsored by
Sanwa Kagaku Kenkyusho Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Hammersmith Medicines Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy

Arm Description

Outcomes

Primary Outcome Measures

The receptor occupancy of SK-1405 as measured by PET-CT imaging with [11C]-carfentanil

Secondary Outcome Measures

Full Information

First Posted
January 5, 2016
Last Updated
April 10, 2016
Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02650076
Brief Title
A Study to Investigate the Receptor Occupancy of SK-1405 in Healthy, Caucasian, Male Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Arm Title
Healthy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SK-1405
Primary Outcome Measure Information:
Title
The receptor occupancy of SK-1405 as measured by PET-CT imaging with [11C]-carfentanil
Time Frame
up to 4 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Facility Information:
Facility Name
Hammersmith Medicines Research
City
London
Country
United Kingdom

12. IPD Sharing Statement

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A Study to Investigate the Receptor Occupancy of SK-1405 in Healthy, Caucasian, Male Subjects

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