Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ketoconazole+ GW642444M · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | Ketoconazole 400mg OD days 1-6 |
| Placebo | PLACEBO_COMPARATOR | Placebo OD for 1 to 6 days |
| Name | Type | Description |
|---|---|---|
| Ketoconazole + GW642444M | DRUG | Ketoconazole 400mg OD days 1-6, GW642444M 25ug single dose on D5 |
| Placebo + GW642444M | DRUG | Placebo to match D1-6 + GW642444M 25ug single dose on D5 |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range ...
Ketoconazole is an investigational small molecule being studied in Phase 1 clinical trials for conditions including chemotherapy-induced nausea and vomiting, type 2 diabetes mellitus, chronic obstructive pulmonary disease, and cancer. It is being developed by GSK plc (GSK) and has been evaluated in healthy volunteers and patients with BRAF mutant solid tumors.
Ketoconazole is being developed by GSK plc, which trades under the ticker GSK. The company has sponsored Phase 1 clinical trials involving the drug across multiple indications, including oncology and metabolic and respiratory conditions.
Ketoconazole is in Phase 1 clinical development. It is investigational and not approved for any use. One Phase 1 study has been completed, with no active trials currently listed.
Ketoconazole has been studied in completed Phase 1 trials including NCT00404378, NCT00501397, NCT00866515, and NCT01340846. These trials assessed drug interactions and pharmacokinetics in healthy volunteers and in patients with BRAF mutant solid tumors.
Ketoconazole is not the same as casopitant or GSK189075. It was studied as an interacting drug in trials of those investigational agents, such as NCT00404378 with casopitant and NCT00501397 with GSK189075, to assess how ketoconazole affects their pharmacokinetics.