Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GDC-0134 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SAD Stage: GDC-0134 | EXPERIMENTAL | Participants in multiple cohorts and treatment periods will receive single doses of GDC-0134 oral capsules under fed/fasting conditions. To study the effect of proton pump inhibitor (PPI) medication rabeprazole on PK properties of GDC-0134, few participants may receive rabeprazole 20 milligrams (mg). |
| SAD Stage: Placebo | PLACEBO_COMPARATOR | Participants in multiple cohorts and treatment periods will receive placebo matching to GDC-0134 under fed/fasting conditions. Few participants may receive rabeprazole 20 mg. |
| MAD Stage: GDC-0134 | EXPERIMENTAL | Participants will receive multiple doses of GDC-0134 for 28 days. To study the interactions between GDC-0134 and other drugs, some participants may receive single doses of midazolam and caffeine at various time points. |
| MAD Stage: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to GDC-0134 for 28 days. To study the interactions between GDC-0134 and other drugs, some participants may receive single doses of midazolam and caffeine at various time points. |
| Open-Label Safety Expansion (OSE) | OTHER | Participants will receive GDC-0134 at a dose determined by the corresponding MAD cohort. |
| Name | Type | Description |
|---|---|---|
| GDC-0134 | DRUG | GDC-0134 capsule will be administered orally at various doses, depending on the cohort and treatment period. |
| Placebo | DRUG | Placebo matching to GDC-0134 |
| Rabeprazole | DRUG | Rabeprazole 20 mg twice daily orally |
| Midazolam | DRUG | 2mg of liquid formulation of midazolam orally |
| Caffeine | DRUG | 100 mg tablet or solution of caffeine orally |
Inclusion Criteria: * Male or female participants with a diagnosis of possible, laboratory-supported probable, probable, or definite ALS according to modified El Escorial criteria * Upright forced vital capacity of at least 50 percent (%) * Ability to fast from food for 8 hours prior to dosing and ...
GDC-0134 is an investigational small molecule being studied for the treatment of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. It is in Phase 1 clinical development and has not been approved by regulatory authorities.
GDC-0134 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research to evaluate the drug's safety and tolerability in patients with amyotrophic lateral sclerosis.
GDC-0134 is in Phase 1 clinical development. A Phase 1 trial has been completed, meaning the drug is still in the early stages of clinical testing and remains investigational. It has not received FDA approval.
GDC-0134 has one completed clinical trial, NCT02655614, which evaluated initial safety, tolerability, and pharmacokinetic parameters in participants with amyotrophic lateral sclerosis. The trial enrolled 54 participants across the United States, Canada, and the Netherlands.
No, GDC-0134 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. Further clinical development and regulatory review would be required before it could be considered for approval.