A Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-SK-1405

Sanwa Kagaku Kenkyusho

Status and phase

Completed

Phase 1

Conditions

Pruritus

Treatments

Drug: [14C]-SK-1405

Study type

Interventional

Funder types

Industry

Identifiers

NCT02846181

MO002A

Details and patient eligibility

About

The primary objectives of the study are:

To assess the mass balance recovery after a single PO dose of [14C]-SK-1405
To provide plasma, urine and faecal samples for metabolite profiling and structural identification

Enrollment

6 patients

Sex

Male

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males
Age 30 to 65 years of age
Body mass index of 18.0 to 30.0 kg/m2
Must be willing and able to communicate and participate in the whole study
Must provide written informed consent
Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
Must agree to use an adequate method of contraception

Exclusion criteria

Participation in a clinical research study within the 3 months prior to IMP dose
Subjects who are study site employees, or immediate family members of a study site or sponsor employee
Subjects who have previously been enrolled in this study
Subjects who have been dosed with SK-1405 in the past
Subjects who are taking, or have taken, antiepileptic and/or antidepressant medication in the 6 months prior to dosing
Subjects who are taking, or have taken, any prescribed medication in the 28 days prior to dosing, unless judged as not clinically significant by the investigator and sponsor
Subjects who are taking, or have taken, any over-the-counter medication (with the exception of up to 2,000 mg/day paracetamol/acetaminophen) in the 7 days prior to dosing, unless judged as not clinically significant by the investigator and sponsor
Use, during the 28 days prior to dosing, of any medicine or herbal remedy (such as St John's wort) known to induce or inhibit CYP enzymes, unless judged as not clinically significant by the investigator and sponsor
History of any drug or alcohol abuse in the past 2 years
History of clinically significant neurological conditions
A QTcF >450 msec at screening, admission or pre-dose (as confirmed by a repeat ECG)
Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products. A breath carbon monoxide reading of greater than 10 ppm at screening or admission
Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
Subjects who have been enrolled in an ADME study in the last 12 months
Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator, including AST, ALT or alkaline phosphatase >1.5 × upper limit of normal confirmed by repeat testing 18. Positive drugs of abuse test result
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <90 mL/min using the Cockcroft-Gault equation
History of clinically significant psychiatric, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
History of gastrointestinal surgery (except appendectomy) or any condition that may affect the absorption, distribution, metabolism or excretion of study drug in the opinion of the investigator
Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Presence or history of clinically significant allergy (including food or drug allergy) requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
Donation or loss of greater than 400 mL of blood within the 3 months prior to IMP dose
Subjects who have consumed St John's wort, red wine, Seville oranges, grapefruit or grapefruit juice within 7 days prior to dosing. Subjects must be willing to refrain from consuming such products until the last PK sample
Failure to satisfy the investigator of fitness to participate for any other reason