Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06173596 | A Study to Evaluate Potential Drug Interactions Between ALXN2080 and Itraconazole, Fluconazole & Carbamazepine in Healthy Adults | PHASE1 | COMPLETED | 60 | — | — | Jan 10, 2024 | May 16, 2024 | Jun 20, 2024 | 1 | United Kingdom |
| NCT06160414 | A Study to Investigate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants | PHASE1 | COMPLETED | 20 | — | — | Apr 12, 2023 | Feb 5, 2024 | Apr 24, 2025 | 1 | United Kingdom |
| NCT05428696 | Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants | PHASE1 | COMPLETED | 90 | — | — | Sep 12, 2022 | May 26, 2023 | Jun 7, 2024 | 1 | United Kingdom |
| 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...