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

Pruritus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650076
• Other study ID #: MO001A
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2016
• Last updated: April 10, 2016
• Start date: January 2016

Study information

• Verified date: April 2016
• Source: Sanwa Kagaku Kenkyusho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pruritus

Intervention

Drug:
• SK-1405

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Sanwa Kagaku Kenkyusho Co., Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The receptor occupancy of SK-1405 as measured by PET-CT imaging with [11C]-carfentanil		up to 4 days	No