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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05152680 | Mass Balance Study of NV-5138 in Healthy Male Subjects. | PHASE1 | COMPLETED | 6 | — | — | Nov 11, 2021 | Dec 9, 2021 | Mar 15, 2022 | 1 | United Kingdom |
| NCT05384977 | Mass Balance Study of NV-5138 in Healthy Male Subjects | PHASE1 | COMPLETED | 6 | — | — | Nov 11, 2021 | Dec 9, 2021 | May 23, 2022 | 1 | United Kingdom |
The percentage of the radioactive dose recovered in urine, faeces and in total
| Arm | Type | Description |
|---|---|---|
| [14C]-NV-5138 | EXPERIMENTAL | \[14C\]-NV-5138 oral solution |
| Name | Type | Description |
|---|---|---|
| [14C]-NV-5138 | DRUG | Single dose, given as oral solution, 1600 mg |
Inclusion Criteria: * Healthy males aged 40 to 65 years inclusive at the time of signing informed consent. * Body mass index of 18.0 to 32.0 kg/m2 as measured at screening Exclusion Criteria: * Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1 * Sub...