The Sponsor is developing the test medicine, AZD5718, for the potential treatment of cardiovascular disease. The study is an open-label, single dose study involving 6 healthy male subjects. The volunteers will receive a single dose of 200 mg radiolabelled AZD5718 (14C-AZD5718 Oral Suspension) containing not more than 9.9 MBq of radiocarbon. Volunteers will attend the clinic for 9 days (Day -1 to Day 8) to receive a single dose of the test medicine. It is planned that the volunteers will be discharged as a group once all volunteers have reached the discharge criteria. This may result in the subjects being discharged as a group prior to completion of the planned residency period. If the discharge criteria are not met by volunteers by Day 8, the individual volunteers who have not met the criteria will remain in the clinical unit for a further 48 h (until Day 10). A follow-up call will take place 7 to 10 days after discharge to ensure the ongoing wellbeing of volunteers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
200 mg dose of \[14C\]AZD5718 Oral Suspension
Research Site
Ruddington, United Kingdom
The amount of AZD5718 excreted (Ae)
Assessment of the total radioactivity by measuring the amount of AZD5718 excreted (Ae)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Amount of AZD5718 excreted and expressed as a percentage of the administered dose (Fe)
Assessment of the total radioactivity by measuring the amount of AZD5718 excreted and expressed as a percentage of the administered dose (Fe)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD5718 excreted (CumAe)
Assessment of the total radioactivity by measuring the cumulative amount of AZD5718 excreted (CumAe)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD5718 excreted and expressed as a percentage of the administered dose (CumFe)
Assessment of the total radioactivity by measuring the cumulative amount of AZD5718 excreted and expressed as a percentage of the administered dose (CumFe)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Collection of urine samples from pre-dose until 168 hours post-dose
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Collection of faecal samples from pre-dose until 168 hours post-dose
Time to maximum concentration (tmax) for AZD5718 and total radioactivity
Assessment of AZD5718 and total radioactivity by measuring the time to maximum concentration (tmax)
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Maximum plasma concentration (cmax) for AZD5718 and total radioactivity
Assessment of AZD5718 and total radioactivity by measuring the maximum plasma concentration (cmax)
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Area under the concentration time curve to the last quantifiable concentration (AUC last) for AZD5718 and total radioactivity
Assessment of AZD5718 and total radioactivity by measuring the concentration time curve to the last quantifiable concentration (AUC last)
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Area under the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf) for AZD5718 and total radioactivity
Assessment of AZD5718 and total radioactivity by measuring the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf)
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Apparent terminal Elimination Half-life (t1/2,λz) for AZD5718 and total radioactivity
Assessment of AZD5718 and total radioactivity by measuring the Elimination Half-life (t1/2,λz)
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Oral clearance (CL/F) of AZD5718
Assessment of the oral clearance of AZD5718 by measuring the apparent oral clearance (CL/F)
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Apparent Volume of Distribution (Vz/F) of AZD5718
Assessment of the oral PK (pharmacokinetics) of AZD5718by measuring the Apparent Volume of Distribution (Vz/F)
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
The amount of AZD5718 excreted (Ae)
Assessment of the oral PK (pharmacokinetics) of AZD5718 by measuring the amount of AZD5718 excreted (Ae)
Time frame: Collection of urine and faecal samples from pre-dose until 168 hours post-dose
Amount of AZD5718 excreted and expressed as a percentage of the administered dose (Fe)
Assessment of the oral PK (pharmacokinetics) of AZD5718 by measuring the amount of AZD5718 excreted and expressed as a percentage of the administered dose (Fe)
Time frame: Collection of urine and faecal samples from pre-dose until 168 hours post-dose
Renal clearance (Clr) in urine of AZD5718
Assessment of the oral PK (pharmacokinetics) by measuring the renal clearance (Clr)
Time frame: Collection of urine samples from pre-dose until 168 hours post-dose
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Assessment of total radioactivity in whole blood and plasma
Time frame: Blood samples collected until 168 hours post-dose
Number of adverse events (AE) experienced by subjects
Safety and tolerability assessed through incidence of AE
Time frame: AEs recorded from the time of informed consent until discharge from the study (168 hours post-dose)
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