Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO5424802 · 3 trials · 1 indication
AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (\*) hour per milliliter (ng\*hour/mL).
AUC(0-last) is the area under the alectinib plasma concentration versus time curve from time zero to the time of last measured concentration of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng\*hour/mL.
Cmax is the maximum observed plasma alectinib concentration, presented in nanogram per milliliter (ng/mL).
| Arm | Type | Description |
|---|---|---|
| Ro542-4802/F03;Ro542-4802/F07;Ro542-4802/F14;Ro542-4802/F08 | EXPERIMENTAL | Participants will receive Ro542-4802/F03 (containing 50% SLS) capsules orally on Day 1 of first intervention period; then Ro542-4802/F07 (containing 25% SLS) capsules orally on Day 1 of second intervention period; then Ro542-4802/F14 (containing 12.5% SLS) capsules orally on Day 1 of third intervention period; followed by Ro542-4802/F08 (containing 3% SLS) capsules orally on Day 1 of fourth intervention period during both fasted (Part 1) and fed (Part 2) conditions. A washout period of at least 10 days will be maintained between each period. |
| Ro542-4802/F07;Ro542-4802/F08;Ro542-4802/F03;Ro542-4802/F14 | EXPERIMENTAL | Participants will receive Ro542-4802/F07 (containing 25% SLS) capsules orally on Day 1 of first intervention period; then Ro542-4802/F08 (containing 3% SLS capsules orally on Day 1 in second intervention period; then Ro542-4802/F03 (containing 50% SLS) (containing 12.5% SLS) capsules orally on Day 1 of third intervention period; followed by Ro542-4802/F14 (containing 12.5% SLS) capsules orally on Day 1 of the fourth intervention period during both fasted (Part 1) and fed (Part 2) conditions. A washout period of at least 10 days will be maintained between each period. |
| Ro542-4802/F08;Ro542-4802/F14;Ro542-4802/F07;Ro542-4802/F03 | EXPERIMENTAL | Participants will receive Ro542-4802/F08 (containing 3% SLS) capsules orally on Day 1 of first intervention period; then Ro542-4802/F14 (containing 12.5% SLS) capsules orally on Day 1 in second intervention period; then Ro542-4802/F07 (containing 25% SLS) capsules orally on Day 1 of third intervention period; followed by Ro542-4802/F03 (containing 50% SLS) capsules orally on Day 1 of the fourth intervention period during both fasted (Part 1) and fed (Part 2) conditions. A washout period of at least 10 days will be maintained between each period. |
| Ro542-4802/F14;Ro542-4802/F03;Ro542-4802/F08;Ro542-4802/F07 | EXPERIMENTAL | Participants will receive Ro542-4802/F14 (containing 12.5% SLS) capsules orally on Day 1 of first intervention period; then Ro542-4802/F03 (containing 50% SLS) capsules orally on Day 1 in second intervention period; then Ro542-4802/F08 (containing 3% SLS) capsules orally on Day 1 of third intervention period; followed by Ro542-4802/F07 (containing 25% SLS) capsules orally on Day 1 of the fourth intervention period during both fasted (Part 1) and fed (Part 2) conditions. A washout period of at least 10 days will be maintained between each period. |
| RO5424802 | EXPERIMENTAL | - |
| Healthy subjects | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Ro542-4802/F03 (Reference) | DRUG | Participants will receive Ro542-4802/F03 (containing 50% SLS) 600 mg capsules orally on Day 1. |
| Ro542-4802/F07 (Test) | DRUG | Participants will receive Ro542-4802/F07 (containing 25% SLS) 600 mg capsules orally on Day 1. |
| Ro542-4802/F08 (Test) | DRUG | Participants will receive Ro542-4802/F08 (containing 3% SLS) 600 mg capsules orally on Day 1. |
| Ro542-4802/F14 (Test) | DRUG | Participants will receive Ro542-4802/F14 (containing 12.5% SLS) 600 mg capsules orally on Day 1. |
| RO5424802 | DRUG | Single oral doses followed by IV or oral administration of a 14C-labeled tracer |
| rifampin | DRUG | Multiple doses Days 8-16 and Days 17-20 |
Inclusion Criteria: * Healthy male and surgically sterile or post-menopausal female participants 18-55 years of age * Body mass index (BMI) between 18 to 32 kilograms per meter-squared (kg/m\^2) * Non-smoking participants and former smoking participants (who have not smoked for the past six months ...
RO5424802 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and remains in clinical development. All completed trials for RO5424802 enrolled healthy volunteers to assess pharmacokinetics, drug interactions, elimination, and formulation bioequivalence.
RO5424802 is being developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. The company has sponsored Phase 1 clinical trials of the drug in healthy volunteers.
RO5424802 is in Phase 1 clinical development. All three trials of the drug are Phase 1 studies that have been completed. The drug is investigational and has not been approved by regulatory authorities.
RO5424802 has three completed Phase 1 trials: NCT01940510, a rifampin drug interaction study; NCT01981005, an elimination, pharmacokinetics, and metabolism study; and NCT02074553, a bioequivalence study of three test formulations versus a reference formulation. Total enrollment across these trials was 127 healthy volunteers.
Yes, RO5424802 is also known as alectinib. One completed trial, NCT02074553, explicitly refers to alectinib (RO5424802) in its title, confirming that the two names refer to the same drug.