Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04407091 | A Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolite Profile and Metabolite Identification of [14C]AZD4831 | PHASE1 | COMPLETED | 8 | — | — | Jun 30, 2020 | Aug 6, 2020 | Aug 25, 2020 | 1 | United Kingdom |
Assessment of the total radioactivity by measuring the cumulative amount of AZD4831 excreted (CumAe)
Assessment of the total radioactivity by measuring the cumulative amount of AZD4831 excreted and expressed as a percentage of the administered dose (CumFe)
Assessment of metabolites and structural identification by AMS analysis
Assessment of metabolites and structural identification by AMS analysis
Assessment of metabolites and structural identification by AMS analysis
| Arm | Type | Description |
|---|---|---|
| [14C]AZD4831 Oral Solution | EXPERIMENTAL | One 10 mg dose of \[14C\]AZD4831 Oral Solution |
| Name | Type | Description |
|---|---|---|
| 14C]AZD4831 Oral Solution | DRUG | 10 mg dose of \[14C\]AZD4831 Oral Solution |
Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study specific procedures. 2. Healthy male subjects aged 18 to 65 years inclusive at the time of signing informed consent with suitable veins for cannulation or repeated venepuncture. 3. Body mass index (BMI)...