An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects (NCT03082937) | Clinical Trial Compass
CompletedPhase 1
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
United Kingdom6 participantsStarted 2017-01-31
Plain-language summary
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 \[14C\]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural identification in healthy male subjects.
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 have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
✓. Must provide written informed consent
✓. Must agree to use an adequate method of contraception
Exclusion criteria
✕. Subjects who have received any IMP in a clinical research study within the previous 3 months prior to screening
✕. 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
✕. 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)
✕. Current smokers and those who have smoked within the last 12 months. A confirmed positive urine cotinine test at screening or admission
What they're measuring
1
To assess mass balance recovery of total radioactivity in urine
Timeframe: Between pre-dose (admission to 0 hour) and post dose (ending on morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))
2
To assess mass balance recovery of total radioactivity in faeces
Timeframe: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))
3
Metabolite profiling of A4250 of plasma using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate
Timeframe: Between pre-dose and up to 48 hours post dose
4
Metabolite profiling of A4250 of urine using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate
Timeframe: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))
5
Metabolite profiling of A4250 of faeces using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate
Timeframe: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))
✕. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
✕. 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