Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ketoconazole · 3 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Warfarin dosed at 15mg |
| Part B | EXPERIMENTAL | Ketoconazole dosed at 400mg |
| Part C | EXPERIMENTAL | Gemfibrozil dosed at 600mg |
| Part D | EXPERIMENTAL | GSK2118436 dosed alone |
| Cohort 1 Treatment Period 1 | EXPERIMENTAL | Subjects will receive single oral dose of 100 milligram (mg) of Casopitant. There will be wash out period of 7 days. |
| Cohort 1 Treatment Period 2 | EXPERIMENTAL | Subjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 100 mg along with ketoconazole. |
| Cohort 2 Treatment Period 1 | EXPERIMENTAL | Subjects will receive single oral dose of 50 mg of Casopitant. There will be wash out period of 7 days. |
| Cohort 2 Treatment Period 2 | EXPERIMENTAL | Subjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 50 mg along with ketoconazole. |
| Name | Type | Description |
|---|---|---|
| Warfarin | DRUG | Warfarin dosed at 15mg on Day 1 and Day 22 |
| Ketoconazole | DRUG | Ketoconazole dosed at 400mg daily on Days 19 through 22 |
| Gemfibrozil | DRUG | Gemfibrozil dosed at 600mg twice daily on Days 19 through 22 |
| GSK2118436 150mg | DRUG | GSK2118436 dosed at 150mg twice daily |
| GSK2118436 75mg | DRUG | GSK2118436 dosed at 75mg twice daily |
| GSK189075 | DRUG | - |
| casopitant 100 mg | DRUG | Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time |
| Casopitant 50 mg | DRUG | Casopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time. |
Inclusion Criteria: * Male or female at least 18 years of age at the time of signing the informed consent form; * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form; * Body weight \>/= 45 kg and a body mass index \...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
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.