Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Levoketoconazole 150 · 1 trial · 1 indication
Maximum observed plasma concentration (Cmax) of metformin with and without concomitant administration of levoketoconazole.
Time to maximum concentration (Tmax) of metformin with and without concomitant administration of levoketoconazole.
Area under the plasma concentration-time curve (AUC) from time 0 to time of last measurable plasma concentration (AUClast) and from time 0 extrapolated to infinity (AUCinf) of metformin with and without concomitant administration of levoketoconazole.
| Arm | Type | Description |
|---|---|---|
| Metformin Only | OTHER | - |
| Levoketoconazole Only | OTHER | - |
| Levoketoconazole + Metformin | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Metformin 500 mg Oral Tablet | DRUG | single dose |
| Levoketoconazole 150 - 600 mg (BID) | DRUG | escalating dose from 150 mg to 600 mg (BID) |
Inclusion Criteria: 1. 18-55 years of age, inclusive, at time of consent. 2. Body mass index (BMI) between 18 and 32 kg/m2, inclusive. 3. In good general physical health as determined by absence of clinically significant medical history, physical examination findings, vital signs, clinical laborato...
Levoketoconazole 150 is an investigational small molecule being studied in healthy subjects. It is currently in Phase 1 clinical development, with a completed drug interaction study involving metformin. The drug is not approved and remains under investigation.
Levoketoconazole 150 is being developed by Xeris Biopharma Holdings, Inc., which trades under the ticker XERS. The company is conducting clinical trials to evaluate the drug's effects in healthy subjects.
Levoketoconazole 150 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in healthy subjects. One Phase 1 trial has been completed.
Levoketoconazole 150 has one completed Phase 1 trial, NCT03880825, titled "Drug Interaction Study of Levoketoconazole and Metformin." This study enrolled 32 healthy subjects in the United States and was a controlled, non-randomized, open-label trial.
Levoketoconazole 150 is a distinct drug from ketoconazole, though it is being studied for potential interactions with metformin. The clinical trial NCT03880825 specifically evaluates the drug interaction between levoketoconazole and metformin in healthy subjects.