Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vemircopan · 1 trial · 1 indication
Cmax for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of metformin.
AUCt for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of metformin.
Cmax for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of metformin.
Cmax for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of rosuvastatin.
AUCt for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of rosuvastatin.
Cmax for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of rosuvastatin.
Cmax for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of LNG.
AUCt for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of LNG.
Cmax for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of LNG.
Cmax for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of EE.
AUCt for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of EE.
Cmax for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of EE.
Cmax for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on the single-dose PK of vemircopan.
AUCt for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on the single-dose PK of vemircopan.
Cmax for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on the single-dose PK of vemircopan.
| Arm | Type | Description |
|---|---|---|
| Part 1: Vemircopan, Metformin and Rosuvastatin | EXPERIMENTAL | Participants will receive Vemircopan, Metformin and Rosuvastatin in a fixed sequence over 2 periods. Period 1 (8 days): Participants will receive a single dose of metformin on day 1 and a single dose of rosuvastatin on day 4. Period 2 (12 days): Participants will receive vemircopan twice daily from day 1 to day 11. On day 5, participants will receive metformin co-administered with vemircopan. On day 8, participants will receive rosuvastatin co-administered with vemircopan. There will be a washout period of at least 4 days between the dose of rosuvastatin in Period 1 and the first dose of vemircopan in Period 2. |
| Part 2: Vemircopan and LNG/EE-Containing OCs | EXPERIMENTAL | Participants will receive Vemircopan and LNG/EE-Containing OCs in a fixed sequence over 2 periods. Period 1 (7 days): Participants will receive a single dose of OC, consisting of LNG and EE on day 1. Period 2 (10 days): Participants will receive multiple doses of vemircopan from day 1 to day 9. On day 5, participants will receive a single dose of OC co-administered with vemircopan. There will be a washout period of at least 7 days between the dose of OC in Period 1 and the first dose of vemircopan in Period 2. |
| Part 3: Vemircopan and Carbamazepine | EXPERIMENTAL | Participants will receive Vemircopan and Carbemazepine in a fixed sequence over 2 periods. Period 1 (4 days): Participants will receive a single oral dose of vemircopan on day 1. Period 2 (22 days): Participants will receive carbemazepine twice daily from day 1 to day 21. On day 19, participants will receive a single oral dose of vemircopan co-administered with carbamazepine. There will be a washout period of at least 4 days between the dose of vemircopan in Period 1 and the first dose of carbamazepine in Period 2. |
| Name | Type | Description |
|---|---|---|
| Vemircopan | DRUG | Participants will receive oral tablets of Vemircopan. |
| Rosuvastatin | DRUG | Participants will receive oral coated tablets of Rosuvastatin. |
| Metformin | DRUG | Participants will receive oral film-coated tablets of Metformin. |
| Levonorgestrel / Ethinyl Estradiol | DRUG | Participants will receive oral tablets of Levonorgestrel/ Ethinyl Estradiol. |
| Carbamazepine | DRUG | Participants will receive oral chewable tablets of Carbamazepine. |
Inclusion Criteria: * Participants who are medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and ...
Vemircopan is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with one completed trial that evaluated potential drug interactions. The drug is not approved for any indication and remains in early-stage clinical research.
Vemircopan is being developed by AstraZeneca PLC (ticker: AZN). The company is conducting clinical research on this investigational small molecule, which is currently in Phase 1 development.
Vemircopan is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not yet available for clinical use.
Vemircopan has one completed Phase 1 trial, NCT06071442, which studied potential drug interactions with rosuvastatin, metformin, levonorgestrel/ethinyl estradiol-containing oral contraceptives, and carbamazepine. The trial enrolled 60 healthy participants in the United States.
No, Vemircopan is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has not completed the clinical trials and regulatory review processes required for approval.