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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04704739 | Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205 | PHASE1 | COMPLETED | 12 | — | — | Jan 13, 2021 | Mar 10, 2021 | Mar 25, 2021 | 1 | United Kingdom |
To determine the absolute bioavailability of an oral dose of GLPG1205 relative to an intravenous (i.v.) microtracer dose of \[14C\]-GLPG1205
To assess the mass balance recovery after a single oral dose of \[14C\]-GLPG1205
| Arm | Type | Description |
|---|---|---|
| GLPG1205 oral and [14C]-GLPG1205 IV | EXPERIMENTAL | Single oral dose of GLPG1205 followed by \[14C\]-GLPG1205 solution for infusion |
| [14C]-GLPG1205 capsule | EXPERIMENTAL | Single oral dose of GLPG1205 as solid formulation |
| Name | Type | Description |
|---|---|---|
| GLPG1205 film-coated tablets | DRUG | Single oral dose of GLPG1205 |
| [14C]-GLPG1205 solution for infusion | DRUG | A 15-minute IV infusion of \[14C\]-GLPG1205 |
| GLPG1205 capsules | DRUG | Single oral dose of GLPG1205 as solid formulation |
Inclusion Criteria: * Male between 18-64 years of age (extremes included) (Part 1) and between 45-64 years of age (extremes included) (Part 2), on the date of signing the informed consent form. * A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive. * Having a regular (at least) daily defecat...