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

NCT02846181 | Completed Phase 1

• 1 other identifier: MO002A
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pruritus

Outcome Measures

Primary Outcomes (4)

• 14C radioactivity concentration excreted in urine

  Every day for 14 days

• 14C radioactivity concentration excreted in faeces

  Every day for 14 days

• 14C radioactivity concentration in whole blood

  Every day for 14 days

• 14C radioactivity concentration in plasma

  Every day for 14 days

Study Arms (1)

Healthy

EXPERIMENTAL

Drug: [14C]-SK-1405

Interventions

[14C]-SK-1405 DRUG

Healthy

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanwa Kagaku Kenkyusho Co., Ltd.: lead

Study Sites (1)

Quotient Clinical Ltd.

Nottingham, 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
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 27, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2016-09

Locations

GB (1)