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 a small molecule drug candidate developed by Xeris Biopharma Holdings, Inc. It is being studied in a Phase 1 clinical program. The specific therapeutic indication for this asset has not been disclosed.
Levoketoconazole 150 targets the enzymes CYP11B2, CYP17A1, CYP11A1, and CYP11B1. It acts as an inhibitor of these cytochrome P450 enzymes, which are involved in steroid hormone biosynthesis.
Levoketoconazole 150 is being developed by Xeris Biopharma Holdings, Inc., which trades on the Nasdaq under the ticker symbol XERS.
Levoketoconazole 150 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication.
Levoketoconazole 150 has been evaluated in one completed Phase 1 trial, NCT03880825, titled Drug Interaction Study of Levoketoconazole and Metformin. The trial enrolled 32 healthy adult subjects in the United States and used a controlled design.