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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04136327 | A Study in Healthy Male Volunteers to Test How the Test Medicine GLPG1972 is Taken up by the Body When Given by Mouth and Into the Vein as an Injection | PHASE1 | COMPLETED | 6 | — | — | Sep 13, 2019 | Oct 21, 2019 | Nov 20, 2019 | 1 | United Kingdom |
To assess the mass balance, using \[14C\]-GLPG1972
To assess the pharmacokinetics (PK) of GLPG1972 and its main metabolites in plasma
To assess the PK of GLPG1972 and its main metabolites in plasma
To assess the PK of GLPG1972 and its main metabolites in plasma
To assess the PK of GLPG1972 and its main metabolites in plasma
To characterize the elimination pathways and metabolite profile of GLPG1972
| Arm | Type | Description |
|---|---|---|
| GLPG1972 oral and [14C]-GLPG1972 IV | EXPERIMENTAL | GLPG1972 film-coated tablet followed by \[14C\]-GLPG1972 solution for infusion |
| [14C]-GLPG1972 oral solution | EXPERIMENTAL | \[14C\]-GLPG1972 oral solution |
| Name | Type | Description |
|---|---|---|
| GLPG1972 film-coated tablets | DRUG | single oral dose of GLPG1972 |
| [14C]-GLPG1972 solution for infusion | DRUG | a 15-minute IV infusion \[14C\]-GLPG1972 |
| [14C]-GLPG1972 oral solution | DRUG | single oral dose of \[14C\]-GLPG1972 |
Inclusion Criteria: * Male between 30-64 years of age (extremes included), on the date of signing the Informed Consent Form (ICF). * A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive. * Judged to be in good health by the investigator based upon the results of a medical history, physical ex...