A Phase 1 interventional study of Metformin and Rosuvastatin in Healthy, sponsored by Alexion Pharmaceuticals, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Alexion Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
The primary objectives of this study are to determine the effect of multiple doses of ALXN2080 on the single-dose PK of rosuvastatin and to determine the effect of multiple doses of ALXN2080 on the single-dose PK of metformin.
Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Metformin · Drug: Rosuvastatin
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.
Drug: Metformin · Drug: Rosuvastatin · Drug: ALXN2080
Participants will receive Metformin orally, after fasting.
Participants will receive Rosuvastatin orally, after fasting.
Participants will receive ALXN2080 orally, after fasting.
Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin
Time frame: Day 3 up to Day 12
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Rosuvastatin
Time frame: Day 3 up to Day 12
Cmax of Metformin
Time frame: Day 1 up to Day 9
AUC0-inf of Metformin
Time frame: Day 1 up to Day 9
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 29
Cmax of ALXN2080
Time frame: Day 1 up to Day 18
Area Under the Plasma Concentration Versus Time Curve for the Defined Interval Between Doses AUC(tau) of ALXN2080
Time frame: Day 1 up to Day 18
Plan to share: Yes — Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Alexion Pharmaceuticals, Inc.