The Sponsor is developing a new test medicine, AZD0780, with the aim to lower low-density lipoprotein cholesterol (LDL-C, fatty deposits) levels and cardiovascular (heart disease) risk, when given on top of standard care. This two-part healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14; also referred as 14C) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied. This study will take place at one non-NHS site, enrolling up to 8 male volunteers aged between 30 and 55 years.
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Absolute bioavailability (F) - Part 1
Timeframe: Plasma sample collection from pre-dose to 168 hours post-dose
Area under the curve from time 0 extrapolated to infinity for AZD0780 and total radioactivity (AUC0-inf) - Part 1
Timeframe: Plasma sample collection from pre-dose until 168 hours post-dose
Time to maximum concentration (tmax) for AZD0780 and total radioactivity - Part 1
Timeframe: Plasma sample collection from pre-dose until 168 hours post-dose
Maximum observed concentration (Cmax) for AZD0780 and total radioactivity - Part 1
Timeframe: Plasma sample collection from pre-dose until 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration for AZD0780 and total radioactivity (AUC0-t) - Part 1
Timeframe: Plasma sample collection from pre-dose until 168 hours post-dose
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) and total radioactivity - Part 1
Timeframe: Plasma sample collection from pre-dose until 168 hours post-dose
Terminal elimination half-life for AZD0780 (t1/2) and total radioactivity - Part 1
Timeframe: Plasma sample collection from pre-dose until 168 hours post-dose
First order rate constant associated with the terminal (log-linear) portion of the curve for AZD0780 (λz) and total radioactivity - Part 1
Timeframe: Plasma sample collection from pre-dose until 168 hours post-dose
Total body clearance calculated after a single IV administration (CL) - Part 1
Timeframe: Plasma sample collection from pre-dose until 168 hours post-dose
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) - Part 1
Timeframe: Plasma sample collection from pre-dose until 168 hours post-dose
Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single IV administration (Vz) - Part 1
Timeframe: Plasma sample collection from pre-dose until 168 hours post-dose
Volume of distribution at steady state after a single IV administration (Vss) - Part 1
Timeframe: Plasma sample collection from pre-dose until 168 hours post-dose
Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) - Part 1
Timeframe: Plasma sample collection from pre-dose until 168 hours post-dose
Amount of AZD0780 excreted (Ae) - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Amount of AZD0780 excreted expressed as a fraction of dose excreted (%Ae) - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
The cumulative amount of AZD0780 exreted (CumAe) - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Cumulative amount of AZD0780 excreted expressed as a fraction of dose excreted (Cum%Ae) - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Time to maximum concentration (tmax) for AZD0780 and total radioactivity - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Maximum observed concentration (Cmax) for AZD0780 and total radioactivity - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration for AZD0780 and total radioactivity (AUC0-t) - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Area under the curve from time 0 extrapolated to infinity for AZD0780 and total radioactivity (AUC0-inf) - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) and total radioactivity - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Terminal elimination half-life for AZD0780 (t1/2) and total radioactivity - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
First order rate constant associated with the terminal (log-linear) portion of the curve for AZD0780 (λz) and total radioactivity - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Renal clearance calculated using plasma AUC (CLR) - Part 2
Timeframe: Urine and faecal samples collected from pre-dose until 240 hours post-dose