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

NCT02650076 | Completed Phase 1

• 1 other identifier: MO001A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus

Outcome Measures

Primary Outcomes (1)

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

  up to 4 days

Study Arms (1)

Healthy

EXPERIMENTAL

Drug: SK-1405

Interventions

SK-1405 DRUG

Healthy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanwa Kagaku Kenkyusho Co., Ltd.: lead

Study Sites (1)

Hammersmith Medicines Research

London, London, United Kingdom

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 8, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2016
• Last Updated: April 12, 2016

Record last verified: 2016-04

Locations

GB (1)