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ALXN2080 · 2 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. |
| 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. |
| 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 drug being developed by AstraZeneca PLC. It has been studied in Phase 1 clinical trials in healthy adult volunteers. The specific disease or condition it is intended to treat has not been publicly disclosed, and it remains in early clinical development.
ALXN2080 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical trials conducted for this asset.
ALXN2080 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
ALXN2080 has been evaluated in two completed Phase 1 trials. NCT05428696 studied safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses in 90 healthy participants. NCT06173596 evaluated potential drug interactions between ALXN2080 and itraconazole, fluconazole, and carbamazepine in 60 healthy adults. Both trials were conducted in the United Kingdom.
Both ALXN2080 Phase 1 trials were randomized, double-blind, and controlled studies conducted in healthy adult volunteers aged 18 and older in the United Kingdom. Together they enrolled 150 participants. NCT05428696 assessed single and multiple ascending doses, while NCT06173596 examined drug-drug interactions with itraconazole, fluconazole, and carbamazepine.