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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03814200 | A Study to Investigate the Effect of Rifampicin on the Uptake and Breakdown of ACT-246475 in Healthy Subjects | PHASE1 | COMPLETED | 14 | — | — | Jan 3, 2019 | Feb 19, 2019 | Jul 3, 2025 | 1 | Netherlands |
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
| Arm | Type | Description |
|---|---|---|
| Treatment period A | EXPERIMENTAL | Treatment A1: saline 0.9% followed by Treatment A2: ACT-246475 |
| Treatment period B | EXPERIMENTAL | Treatment B1: rifampicin followed by Treatment B2: ACT-246475 |
| Name | Type | Description |
|---|---|---|
| Saline | DRUG | Single i.v. infusion of 100 mL saline 0.9% for 30 min |
| ACT-246475 | DRUG | Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions |
| Rifampicin | DRUG | Single i.v. infusion of 600 mg rifampicin (100 mL) for 30 min |
Inclusion Criteria: * Signed informed consent in a language understandable to the subject prior to any study-mandated procedure * Healthy male and female subjects aged between 18 and 65 years (inclusive) at Screening * Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening * Systolic blood ...