Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Sanwa Kagaku Kenkyusho Co., Ltd.
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.