HealthyPhase 1NCT06160414
A Study to Investigate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants
A Phase 1 study testing Metformin, Rosuvastatin and ALXN2080 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Metformin, Rosuvastatin and ALXN2080
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Apr 2023to 5 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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, clinical chemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
- Body Mass Index (BMI) within the range of 18.0 to 32.0 kg/m2 (inclusive) and a minimum body weight of 50.0 kg at screening.
- Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
Who cannot join
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological or other disorders.
- History of meningococcal infection.
- History of additional risk factors for Torsades de Pointes (eg, heart failure, hypokalemia, family history of Long QT syndrome).
- History of clinically significant hypersensitivity or idiosyncratic reaction to the study intervention or related compounds.
- History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within 14 days prior to Period 1 Day 1.
- History of significant multiple and/or severe allergies (hay fever is allowed unless it is active), including significant hypersensitivity reactions to commonly used antibacterial agents, including beta-lactams, penicillin, amoxicillin, aminopenicillin, fluoroquinolones (specifically including ciprofloxacin), cephalosporins, and carbapenems, which in the opinion of the Investigator would make it difficult to provide empiric antibiotic therapy or treat an active infection.
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- Diseases or conditions or previous procedures known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- History of malignancy within 5 years prior to screening, with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
- Known hepatic or biliary abnormalities (including participants with Gilberts syndrome).
- Participants with a history of cholecystectomy or gall stones.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants
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.
- Conditions
- Healthy
- Being tested
- Metformin, Rosuvastatin, ALXN2080
- Keywords
- rosuvastatin, ALXN2080, metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Participants will receive Metformin orally, after fasting.
RosuvastatinDrug
Participants will receive Rosuvastatin orally, after fasting.
ALXN2080Drug
Participants will receive ALXN2080 orally, after fasting.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Metformin; Drug: Rosuvastatin |
| 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. Receives: Drug: Metformin; Drug: Rosuvastatin; Drug: ALXN2080 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin
Measured: Day 3 up to Day 12
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Rosuvastatin
Measured: Day 3 up to Day 12
Cmax of Metformin
Measured: Day 1 up to Day 9
AUC0-inf of Metformin
Measured: Day 1 up to Day 9
Secondary outcomes (3)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Baseline up to Day 29
Cmax of ALXN2080
Measured: Day 1 up to Day 18
Area Under the Plasma Concentration Versus Time Curve for the Defined Interval Between Doses AUC(tau) of ALXN2080
Measured: Day 1 up to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start12 Apr 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160414
- Sponsor's protocol ID
- D7420C00002
- Status last verified
- Apr 2025
- First submitted
- 29 Nov 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06160414
- Acronym / sponsor ID
- D7420C00002
- Conditions
- Healthy
- Keywords
- rosuvastatin, ALXN2080, metformin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Metformin, Drug: RosuvastatinOn 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 | Drug: Metformin, Drug: Rosuvastatin, Drug: ALXN2080All 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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, clinical chemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
- Body Mass Index (BMI) within the range of 18.0 to 32.0 kg/m2 (inclusive) and a minimum body weight of 50.0 kg at screening.
- Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
Key exclusion criteria (10 listed)
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological or other disorders.
- History of meningococcal infection.
- History of additional risk factors for Torsades de Pointes (eg, heart failure, hypokalemia, family history of Long QT syndrome).
- History of clinically significant hypersensitivity or idiosyncratic reaction to the study intervention or related compounds.
- History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within 14 days prior to Period 1 Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminParticipants will receive Metformin orally, after fasting. | Drug | Cohort 1, Cohort 2 |
| RosuvastatinParticipants will receive Rosuvastatin orally, after fasting. | Drug | Cohort 1, Cohort 2 |
| ALXN2080Participants will receive ALXN2080 orally, after fasting. | Drug | Cohort 2 |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin, Rosuvastatin and ALXN2080 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin (time frame: Day 3 up to Day 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.