Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALXN2080 · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | During Part 1, Period 1, participants will receive a single dose of ALXN2080 on the morning of Day 1. In Part 1, Period 2, participants will receive a dose of itraconazole orally once daily on the morning of Day 1 to Day 13. On the morning of Day 5, participants will be given a single dose of ALXN2080 co-administered with itraconazole. |
| Part 2 (Optional) | EXPERIMENTAL | During Part 2, Period 1, participants will receive a single dose of ALXN2080 on the morning of Day 1. In Part 2, Period 2, participants will receive a single loading dose of fluconazole, followed by a dose of fluconazole qd on the morning of Day 2 to Day 10. On the morning of Day 4, participants will be given a single dose of ALXN2080 co-administered with fluconazole. |
| Part 3 | EXPERIMENTAL | During Part 3, Period 1 participants will receive a single dose of ALXN2080 on the morning of Day 1. In Part 3, Period 2, participants will receive a dose of carbamazepine bid on the morning and evening of Day 1 to Day 3, followed by a dose of carbamazepine bid on the morning and evening of Day 4 to Day 6 and a dose of carbamazepine bid on the morning and evening of Day 7 to Day 23. On the morning of Day 19, participants will be given a single dose of ALXN2080 co-administered with carbamazepine. |
| Cohort 1 | EXPERIMENTAL | On Day 1, all participants will receive a single oral dose (fasted) of Metformin followed by a single oral dose (fasted) of Rosuvastatin on Day 3. |
| Cohort 2 | EXPERIMENTAL | All participants will receive ALXN2080 twice daily (BID) on Day 1 to Day 11. On the morning of Day 6, participants will be given a single dose of Metformin co-administered with the morning dose of ALXN2080. On the morning of Day 8, participants will be given a single dose of Rosuvastatin co-administered with the morning dose of ALXN2080. |
| SAD - Cohort 1 | EXPERIMENTAL | Eight participants will receive a single dose of Dose Amount 1 of ALXN2080, and 2 participants will receive placebo. |
| SAD - Cohort 2 | EXPERIMENTAL | Eight participants will receive a single dose of Dose Amount 2 of ALXN2080, and 2 participants will receive placebo. |
| SAD - Cohort 3 | EXPERIMENTAL | Eight participants will receive a single dose of Dose Amount 3 of ALXN2080, and 2 participants will receive placebo. |
| SAD - Cohort 4 | EXPERIMENTAL | Eight participants will receive a single dose of Dose Amount 4 of ALXN2080, and 2 participants will receive placebo. |
| SAD - Cohort 5 | EXPERIMENTAL | Eight participants will receive a single dose of Dose Amount 5 of ALXN2080, and 2 participants will receive placebo. |
| SAD - Cohort 6 | EXPERIMENTAL | Eight participants will receive a single dose of Dose Amount 6 of ALXN2080, and 2 participants will receive placebo. |
| MAD - Cohort 1 | EXPERIMENTAL | Eight participants will receive multiple doses of Dose Amount A of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days. |
| MAD - Cohort 2 | EXPERIMENTAL | Eight participants will receive multiple doses of Dose Amount B of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days. |
| MAD - Cohort 3 | EXPERIMENTAL | Eight participants will receive multiple doses of Dose Amount C of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days. |
| MAD - Cohort 4 | EXPERIMENTAL | Eight participants will receive multiple doses of Dose Amount D of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days. |
| Name | Type | Description |
|---|---|---|
| ALXN2080 | DRUG | Participants will receive ALXN2080 orally. |
| Itraconazole | DRUG | Participants will receive Itraconazole orally. |
| Fluconazole (AxMP) | DRUG | Participants will receive Fluconazole orally. |
| Carbamazepine (AxMP) | DRUG | Participants will receive Carbamazepine orally. |
| Metformin | DRUG | Participants will receive Metformin orally, after fasting. |
| Rosuvastatin | DRUG | Participants will receive Rosuvastatin orally, after fasting. |
| Placebo | DRUG | Powder-in-capsule |
Inclusion Criteria: * Healthy males or non-pregnant, non-lactating healthy females. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, triplicate 12-lead ECG, screening clinical laboratory profiles (hematology, cl...
ALXN2080 is an investigational small molecule being developed by AstraZeneca PLC (ticker: AZN). It is currently in Phase 1 clinical development, with studies conducted in healthy participants. The drug is being evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics, as well as potential drug interactions.
ALXN2080 is being studied in healthy volunteers as part of early-phase clinical trials. Its intended therapeutic use has not been specified in the available data, and it is not yet approved for any medical condition. The ongoing research focuses on understanding the drug's safety profile and how it behaves in the body.
ALXN2080 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting Phase 1 clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy participants.
ALXN2080 is in Phase 1 clinical development. All three completed trials involving this drug were Phase 1 studies conducted in healthy participants. The drug is investigational and has not been approved by regulatory authorities for any use.
ALXN2080 has been studied in three completed Phase 1 clinical trials: NCT05428696, which evaluated single and multiple doses in 90 healthy participants; NCT06160414, which investigated drug interactions with rosuvastatin and metformin in 20 participants; and NCT06173596, which assessed interactions with itraconazole, fluconazole, and carbamazepine in 60 participants.
No alternative names for ALXN2080 have been reported. The drug is identified solely by its code name ALXN2080 in clinical trial registries and available data. It is a distinct investigational compound being developed by AstraZeneca.