Bioavailability of [14C]-SK-1404 ADME & IV Microtracer Study (NCT02878096) | Clinical Trial Compass
CompletedPhase 1
Bioavailability of [14C]-SK-1404 ADME & IV Microtracer Study
United Kingdom6 participantsStarted 2016-07
Plain-language summary
The primary objectives of the study are:
* To determine the absolute bioavailability of SK-1404
* To assess the mass balance recovery after a single oral (PO) dose of carbon-14 (14C)-SK-1404
* To provide plasma, urine and faecal samples for metabolite profiling and structural identification
The secondary objectives of the study are:
* To determine the routes and rates of elimination of \[14C\]-SK-1404
* To identify the chemical structure of each metabolite with an exposure (AUC) of more than 10% of circulating total radioactivity
* To explore the intravenous (IV) pharmacokinetics (PK) of \[14C\]-SK-1404
* To further explore the PO PK of SK-1404
* To provide additional safety and tolerability information for SK-1404
Who can participate
Age range30 Years – 65 Years
SexMALE
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Inclusion criteria
✓. Healthy males
✓. Age 30 to 65 years of age
✓. Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
✓. Must be willing and able to communicate and participate in the whole study
✓. Must provide written informed consent
✓. Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
✓. Must agree to use an adequate method of contraception
Exclusion criteria
✕. Males with pregnant partners
✕. 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
What they're measuring
1
Absolute bioavailability (F) calculated with the AUC values of IV administration in Part 1 and PO administration in Part 2
Timeframe: Predose to 96hr
2
Mass balance recovery of total radioactivity in urine, faeces and all excreta
Timeframe: Predose to 168hr
3
Number and structural identification of known and unknown metabolites of SK-1404 in the plasma, urine and faeces samples
. Subjects who have previously been enrolled in this study
✕. Subjects who have previously been dosed with SK-1404
✕. History of any drug or alcohol abuse in the past 2 years
✕. 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) in the past year
✕. 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