Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Renodapt · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Renodapt Then Mycept Then Cellmune Then CellCept | EXPERIMENTAL | Participants will receive Renodapt in first treatment period (each treatment period= 3 days) followed by Mycept in second treatment period then Cellmune in third treatment period and CellCept in fourth treatment period. A washout period of 7 days will be separating each treatment period. |
| Mycept Then CellCept Then Renodapt Then Cellmune | EXPERIMENTAL | Participants will receive Mycept in first treatment period (each treatment period= 3 days) followed by CellCept in second treatment period then Renodapt in third treatment period and Cellmune in fourth treatment period. A washout period of 7 days will be separating each treatment period. |
| Cellmune Then Renodapt Then CellCept Then Mycept | EXPERIMENTAL | Participants will receive Cellmune in first treatment period (each treatment period= 3 days) followed by Renodapt in second treatment period then CellCept in third treatment period and Mycept in fourth treatment period. A washout period of 7 days will be separating each treatment period. |
| CellCept Then Cellmune Then Mycept Then Renodapt | EXPERIMENTAL | Participants will receive CellCept in first treatment period (each treatment period= 3 days) followed by Cellmune in second treatment period then Mycept in third treatment period and Renodapt in fourth treatment period. A washout period of 7 days will be separating each treatment period. |
| Name | Type | Description |
|---|---|---|
| Renodapt | DRUG | Renodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods. |
| Mycept | DRUG | Mycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods. |
| Cellmune | DRUG | Cellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods. |
| CellCept | DRUG | CellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods. |
Inclusion Criteria: A body mass index (BMI) between 18 and 32 kilogram per meter square (kg/m\^2) Exclusion Criteria: * Any evidence of clinically significant allergic, renal, cardiac, bronchopulmonary, vascular, gastro-intestinal, neurological, metabolic or immunodeficiency disorders, cancer, he...
Renodapt is an investigational small molecule developed by Roche Holding AG. It is a tablet formulation studied in healthy volunteers rather than in patients with a specific disease. Its clinical work to date consists of a single completed Phase 1 pharmacokinetic study conducted in New Zealand.
Renodapt is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program for this asset.
Renodapt is in Phase 1 development. One Phase 1 trial has been completed and no trials are currently active. The program has not advanced beyond early-stage clinical testing, and the compound remains investigational.
Renodapt has been studied in one completed Phase 1 trial, NCT02981290, titled a study to compare the pharmacokinetics of mycophenolate mofetil metabolites from four tablet formulations in healthy participants. That trial enrolled 32 male healthy volunteers aged 18 years and older in New Zealand.
NCT02981290 was a controlled, randomized Phase 1 pharmacokinetic study that was not double blind. It enrolled 32 healthy male volunteers aged 18 years and older at sites in New Zealand and has been completed. Participants were not selected based on a biomarker.
Renodapt has no disclosed patient indication. Its only recorded clinical study was conducted in healthy volunteers to compare pharmacokinetics of mycophenolate mofetil metabolites across four tablet formulations, so the compound is not established as a treatment for any condition.