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| Name | Class |
|---|---|
| Quotient Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]AZD5718 Oral Suspension | Experimental | One 200 mg dose of [14C]AZD5718 Oral Suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]AZD5718 Oral Suspension | Drug | 200 mg dose of [14C]AZD5718 Oral Suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| The amount of AZD5718 excreted (Ae) | Assessment of the total radioactivity by measuring the amount of AZD5718 excreted (Ae) | 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) | 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) | 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) | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of whole blood:plasma concentration ratios for total radioactivity | Assessment of total radioactivity in whole blood and plasma | Blood samples collected until 168 hours post-dose |
| Number of adverse events (AE) experienced by subjects |
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Inclusion Criteria:
Exclusion Criteria:
Healthy male subjects aged 30 to 65 years
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| Name | Affiliation | Role |
|---|---|---|
| Sharan Sidhu, MBChB, BAO, MRCS, MFPM | Quotient Sciences Limited (indemnified by Medical Protection Society) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ruddington | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
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Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry |
| 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Collection of urine samples from pre-dose until 168 hours post-dose |
Safety and tolerability assessed through incidence of AE
| AEs recorded from the time of informed consent until discharge from the study (168 hours post-dose) |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |