Healthy ParticipantsPhase 1NCT06071442
Potential Drug Interaction Study Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel/Ethinyl Estradiol-containing Oral Contraceptives, and Carbamazepine
A Phase 1 study testing Vemircopan, Rosuvastatin and Metformin in people with Healthy Participants, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study will investigate the potential drug interactions between vemircopan and metformin, rosuvastatin, levonorgestrel/ ethinyl estradiol (LNG/EE)-containing oral contraceptive(s) (OCs), and carbamazepine in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Vemircopan, Rosuvastatin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2024to 12 Apr 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
- Participants who are medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
- Body weight of at minimum 50 kg and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive) at the Screening.
- Male and female participants should adhere to the protocol defined contraceptive methods.
Who cannot join
- History or presence of medical (eg, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological or other disorders) or psychiatric conditions or diseases.
- History of clinically significant hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- History of drug or alcohol abuse within 2 years prior to first dosing
- Current tobacco users or smokers (defined as any tobacco or nicotine-containing product use within 3 months prior to first dosing).
- Donation of whole blood from 3 months prior to first dose administration, or of plasma from 30 days before first dose administration.
- Female participants who have a positive pregnancy test at Screening or Day -1, or who are lactating.
- Positive drugs of abuse, cotinine, or alcohol screen at Screening or Day -1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-Part Phase 1 Study to Evaluate the Potential Drug-Drug Interactions Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel-Ethinyl Estradiol-Containing Oral Contraceptives, and Carbamazepine in Healthy Adult Participants
This study will investigate the potential drug interactions between vemircopan and metformin, rosuvastatin, levonorgestrel/ ethinyl estradiol (LNG/EE)-containing oral contraceptive(s) (OCs), and carbamazepine in healthy participants.
Read the detailed description
This a 3-part drug-drug interaction (DDI) study. Part 1 - Potential Drug-drug Interaction Between Vemircopan, Metformin, and Rosuvastatin, Part 2 - Potential Drug-drug Interaction Between Vemircopan and LNG/EE-Containing OCs (Female Participants Only) Part 3 - Potential Drug-drug Interaction Between Vemircopan and Carbamazepine
All the 3 parts of the study includes:
- Screening Period: 27 days (Day -28 through Day -2)
- Two Treatment Periods:
- Part 1: Treatment Period 1 (Day -1 through Day 8) and Treatment Period 2 (Day 1 through Day 12)
- Part 2: Treatment Period 1 (Day -1 through Day 7) and Treatment Period 2 (Day 1 through Day 10)
- Part 3: Treatment Period 1 (Day -1 through Day 4) and Treatment Period 2 (Day 1 through Day 22)
- Follow-up/Early Discontinuation Visit: 7 (± 2) days following the last dose of study intervention
Up to 20 participants will be enrolled per study part. Participants will be enrolled in only one study part and will not be allowed to participate in more than 1 study part.
- Conditions
- Healthy Participants
- Being tested
- Vemircopan, Rosuvastatin, Metformin, Levonorgestrel / Ethinyl Estradiol, Carbamazepine
- Keywords
- Drug-drug interaction, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VemircopanDrug
Also called ALXN2050
Participants will receive oral tablets of Vemircopan.
RosuvastatinDrug
Participants will receive oral coated tablets of Rosuvastatin.
MetforminDrug
Participants will receive oral film-coated tablets of Metformin.
Levonorgestrel / Ethinyl EstradiolDrug
Also called SIMPESSE
Participants will receive oral tablets of Levonorgestrel/ Ethinyl Estradiol.
CarbamazepineDrug
Participants will receive oral chewable tablets of Carbamazepine.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Vemircopan, Metformin and Rosuvastatin | Experimental | Participants will receive Vemircopan, Metformin and Rosuvastatin in a fixed sequence over 2 periods.
Period 1 (8 days): Participants will receive a single dose of metformin on day 1 and a single dose of rosuvastatin on day 4.
Period 2 (12 days): Participants will receive vemircopan twice daily from day 1 to day 11. On day 5, participants will receive metformin co-administered with vemircopan. On day 8, participants will receive rosuvastatin co-administered with vemircopan.
There will be a washout period of at least 4 days between the dose of rosuvastatin in Period 1 and the first dose of vemircopan in Period 2. Receives: Drug: Vemircopan; Drug: Rosuvastatin; Drug: Metformin |
| Part 2: Vemircopan and LNG/EE-Containing OCs | Experimental | Participants will receive Vemircopan and LNG/EE-Containing OCs in a fixed sequence over 2 periods.
Period 1 (7 days): Participants will receive a single dose of OC, consisting of LNG and EE on day 1.
Period 2 (10 days): Participants will receive multiple doses of vemircopan from day 1 to day 9. On day 5, participants will receive a single dose of OC co-administered with vemircopan.
There will be a washout period of at least 7 days between the dose of OC in Period 1 and the first dose of vemircopan in Period 2. Receives: Drug: Vemircopan; Drug: Levonorgestrel / Ethinyl Estradiol |
| Part 3: Vemircopan and Carbamazepine | Experimental | Participants will receive Vemircopan and Carbemazepine in a fixed sequence over 2 periods.
Period 1 (4 days): Participants will receive a single oral dose of vemircopan on day 1.
Period 2 (22 days): Participants will receive carbemazepine twice daily from day 1 to day 21. On day 19, participants will receive a single oral dose of vemircopan co-administered with carbamazepine.
There will be a washout period of at least 4 days between the dose of vemircopan in Period 1 and the first dose of carbamazepine in Period 2. Receives: Drug: Vemircopan; Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Maximum observed plasma (peak) concentration (Cmax) of Metformin
Cmax for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of metformin.
Measured: Up to 48 hours post-dose
Part 1: AUC from time zero to the last quantifiable concentration (AUCt) of Metformin
AUCt for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of metformin.
Measured: Up to 48 hours post-dose
Part 1: AUC from time zero extrapolated to infinity (AUC∞) of Metformin
Cmax for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of metformin.
Measured: Up to 48 hours post-dose
Part 1: Cmax of Rosuvastatin
Cmax for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of rosuvastatin.
Measured: Up to 96 hours post-dose
Part 1: AUCt of Rosuvastatin
AUCt for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of rosuvastatin.
Measured: Up to 96 hours post-dose
Part 1: AUC∞ of Rosuvastatin
Cmax for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of rosuvastatin.
Measured: Up to 96 hours post-dose
Part 2: Cmax of LNG
Cmax for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of LNG.
Measured: Up to 120 hours post-dose
Part 2: AUCt of LNG
AUCt for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of LNG.
Measured: Up to 120 hours post-dose
Part 2: AUC∞ of LNG
Cmax for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of LNG.
Measured: Up to 120 hours post-dose
Part 2: Cmax of EE
Cmax for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of EE.
Measured: Up to 120 hours post-dose
Part 2: AUCt of EE
AUCt for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of EE.
Measured: Up to 120 hours post-dose
Part 2: AUC∞ of EE
Cmax for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of EE.
Measured: Up to 120 hours post-dose
Part 3: Cmax of Vemircopan
Cmax for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on the single-dose PK of vemircopan.
Measured: Up to 72 hours post-dose
Part 3: AUCt of Vemircopan
AUCt for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on the single-dose PK of vemircopan.
Measured: Up to 72 hours post-dose
Part 3: AUC∞ of Vemircopan
Cmax for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on the single-dose PK of vemircopan.
Measured: Up to 72 hours post-dose
Secondary outcomes (40)
Part 1: Number of participants with Treatment Emergent Adverse Events
The safety and tolerability of multiple doses of vemircopan when co-administered with a single dose of metformin, and multiple doses of vemircopan when co-administered with a single dose of rosuvastatin will be assessed.
Measured: From Screening (Day -28 to Day -2) up to follow-up Visit or early discontinuation visit (approximately 57 days)
Part 2: Number of participants with Treatment Emergent Adverse Events
The safety and tolerability of multiple doses of vemircopan when co-administered with a single dose of an oral contraceptive containing both LNG and EE will be assessed.
Measured: From Screening (Day -28 to Day -2) up to follow-up Visit or early discontinuation visit (approximately 54 days)
Part 3: Number of participants with Treatment Emergent Adverse Events
The safety and tolerability of multiple doses of vemircopan when co-administered with multiple doses of carbamazepine will be assessed.
Measured: From Screening (Day -28 to Day -2) up to follow-up Visit or early discontinuation visit (approximately 63 days)
Part 1: Time corresponding to the occurrence of Cmax (tmax) of Metformin
tmax for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on metformin.
Measured: Up to 48 hours post-dose
Part 1: Apparent terminal elimination half-life (t½) of Metformin
t½ for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on metformin.
Measured: Up to 48 hours post-dose
Part 1: Terminal elimination rate constant (λz) of Metformin
λz for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on metformin.
Measured: Up to 48 hours post-dose
Part 1: Volume of distribution (apparent) following extravascular administration (Vd/F) of Metformin
Vd/F for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on metformin.
Measured: Up to 48 hours post-dose
Part 1: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Metformin
CL/F for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on metformin.
Measured: Up to 48 hours post-dose
Part 1: tmax of Rosuvastatin
tmax for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on rosuvastatin.
Measured: Up to 96 hours post-dose
Part 1: t½ of Rosuvastatin
t½ for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on rosuvastatin.
Measured: Up to 96 hours post-dose
Part 1: λz of Rosuvastatin
λz for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on rosuvastatin.
Measured: Up to 96 hours post-dose
Part 1: Vd/F of Rosuvastatin
Vd/F for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on rosuvastatin.
Measured: Up to 96 hours post-dose
Part 1: CL/F of Rosuvastatin
CL/F for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on rosuvastatin.
Measured: Up to 96 hours post-dose
Part 1: Cmax of Vemircopan
Cmax of vermircopan after multiple twice daily doses will be assessed.
Measured: Period 2: Days 4, 5 and 8
Part 1: AUC during a dosing interval at steady state (AUCtau) of Vemircopan
AUCtau of vermircopan after multiple twice daily doses will be assessed.
Measured: Period 2: Days 4, 5 and 8
Part 1: tmax of Vemircopan
tmax of vermircopan after multiple twice daily doses will be assessed.
Measured: Period 2: Days 4, 5 and 8
Part 1: Predose concentration prior to morning dose (Ctrough) of Vemircopan
Ctrough of vermircopan after multiple twice daily doses will be assessed.
Measured: Period 2: Days 3, 4, 5 and 8
Part 2: tmax of LNG
tmax for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on LNG.
Measured: Up to 120 hours post-dose
Part 2: t½ of LNG
t½ for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on LNG.
Measured: Up to 120 hours post-dose
Part 2: λz of LNG
λz for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on LNG.
Measured: Up to 120 hours post-dose
Part 2: Vd/F of LNG
Vd/F for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on LNG.
Measured: Up to 120 hours post-dose
Part 2: CL/F of LNG
CL/F for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on LNG.
Measured: Up to 120 hours post-dose
Part 2: tmax of EE
tmax for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on EE.
Measured: Up to 120 hours post-dose
Part 2: t½ of EE
t½ for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on EE.
Measured: Up to 120 hours post-dose
Part 2: λz of EE
λz for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on EE.
Measured: Up to 120 hours post-dose
Part 2: Vd/F of EE
Vd/F for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on EE.
Measured: Up to 120 hours post-dose
Part 2: CL/F of EE
CL/F for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on EE.
Measured: Up to 120 hours post-dose
Part 2: Cmax of Vemircopan
Cmax of vermircopan after multiple twice daily doses will be assessed.
Measured: Period 2: Days 4, and 5
Part 2: AUCtau of Vemircopan
AUCtau of vermircopan after multiple twice daily doses will be assessed.
Measured: Period 2: Days 4, and 5
Part 2: tmax of Vemircopan
tmax of vermircopan after multiple twice daily doses will be assessed.
Measured: Period 2: Days 4, and 5
Part 2: Ctrough of Vemircopan
Ctrough of vermircopan after multiple twice daily doses will be assessed.
Measured: Period 2: Days 3, 4, and 5
Part 3: tmax of Vemircopan
tmax for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on vemircopan.
Measured: Up to 72 hours post-dose
Part 3: t½ of Vemircopan
t½ for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on vemircopan.
Measured: Up to 72 hours post-dose
Part 3: λz of Vemircopan
λz for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on vemircopan.
Measured: Up to 72 hours post-dose
Part 3: Vd/F of Vemircopan
Vd/F for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on vemircopan.
Measured: Up to 72 hours post-dose
Part 3: CL/F of Vemircopan
CL/F for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on vemircopan.
Measured: Up to 96 hours post-dose
Part 3: Cmax of Carbamazepine
Cmax of carbamazepine after multiple twice daily doses will be assessed.
Measured: Period 2: Days 4, 18 and 19
Part 3: AUCtau of Carbamazepine
AUCtau of carbamazepine after multiple twice daily doses will be assessed.
Measured: Period 2: Days 4, 18 and 19
Part 3: tmax of Carbamazepine
tmax of carbamazepine after multiple twice daily doses will be assessed.
Measured: Period 2: Days 4, 18 and 19
Part 3: Ctrough of Carbamazepine
Ctrough of carbamazepine after multiple twice daily doses will be assessed.
Measured: Period 2: Days 18 and 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start17 Jan 2024
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT06071442
- Sponsor's protocol ID
- D7841C00012
- Other IDs
- ALXN2050-HV-111
- Status last verified
- Aug 2025
- First submitted
- 2 Oct 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Part Phase 1 Study to Evaluate the Potential Drug-Drug Interactions Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel-Ethinyl Estradiol-Containing Oral Contraceptives, and Carbamazepine in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06071442
- Acronym / sponsor ID
- D7841C00012
- Conditions
- Healthy Participants
- Keywords
- Drug-drug interaction, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 6 Oct 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.
This study will investigate the potential drug interactions between vemircopan and metformin, rosuvastatin, levonorgestrel/ ethinyl estradiol (LNG/EE)-containing oral contraceptive(s) (OCs), and carbamazepine in healthy participants.
Detailed description
This a 3-part drug-drug interaction (DDI) study. Part 1 - Potential Drug-drug Interaction Between Vemircopan, Metformin, and Rosuvastatin, Part 2 - Potential Drug-drug Interaction Between Vemircopan and LNG/EE-Containing OCs (Female Participants Only) Part 3 - Potential Drug-drug Interaction Between Vemircopan and Carbamazepine
All the 3 parts of the study includes:
- Screening Period: 27 days (Day -28 through Day -2)
- Two Treatment Periods:
- Part 1: Treatment Period 1 (Day -1 through Day 8) and Treatment Period 2 (Day 1 through Day 12)
- Part 2: Treatment Period 1 (Day -1 through Day 7) and Treatment Period 2 (Day 1 through Day 10)
- Part 3: Treatment Period 1 (Day -1 through Day 4) and Treatment Period 2 (Day 1 through Day 22)
- Follow-up/Early Discontinuation Visit: 7 (± 2) days following the last dose of study intervention
Up to 20 participants will be enrolled per study part. Participants will be enrolled in only one study part and will not be allowed to participate in more than 1 study part.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Vemircopan, Metformin and Rosuvastatin | Experimental | Drug: Vemircopan, Drug: Rosuvastatin, Drug: MetforminParticipants will receive Vemircopan, Metformin and Rosuvastatin in a fixed sequence over 2 periods. Period 1 (8 days): Participants will receive a single dose of metformin on day 1 and a single dose of rosuvastatin on day 4. Period 2 (12 days): Participants will receive vemircopan twice daily from day 1 to day 11. On day 5, participants will receive metformin co-administered with vemircopan. On day 8, participants will receive rosuvastatin co-administered with vemircopan. There will be a washout period of at least 4 days between the dose of rosuvastatin in Period 1 and the first dose of vemircopan in Period 2. |
| Part 2: Vemircopan and LNG/EE-Containing OCs | Experimental | Drug: Vemircopan, Drug: Levonorgestrel / Ethinyl EstradiolParticipants will receive Vemircopan and LNG/EE-Containing OCs in a fixed sequence over 2 periods. Period 1 (7 days): Participants will receive a single dose of OC, consisting of LNG and EE on day 1. Period 2 (10 days): Participants will receive multiple doses of vemircopan from day 1 to day 9. On day 5, participants will receive a single dose of OC co-administered with vemircopan. There will be a washout period of at least 7 days between the dose of OC in Period 1 and the first dose of vemircopan in Period 2. |
| Part 3: Vemircopan and Carbamazepine | Experimental | Drug: Vemircopan, Drug: CarbamazepineParticipants will receive Vemircopan and Carbemazepine in a fixed sequence over 2 periods. Period 1 (4 days): Participants will receive a single oral dose of vemircopan on day 1. Period 2 (22 days): Participants will receive carbemazepine twice daily from day 1 to day 21. On day 19, participants will receive a single oral dose of vemircopan co-administered with carbamazepine. There will be a washout period of at least 4 days between the dose of vemircopan in Period 1 and the first dose of carbamazepine in Period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants who are medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
- Body weight of at minimum 50 kg and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive) at the Screening.
- Male and female participants should adhere to the protocol defined contraceptive methods.
Key exclusion criteria (7 listed)
- History or presence of medical (eg, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological or other disorders) or psychiatric conditions or diseases.
- History of clinically significant hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- History of drug or alcohol abuse within 2 years prior to first dosing
- Current tobacco users or smokers (defined as any tobacco or nicotine-containing product use within 3 months prior to first dosing).
- Donation of whole blood from 3 months prior to first dose administration, or of plasma from 30 days before first dose administration.
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 |
|---|---|---|
| VemircopanAlso: ALXN2050Participants will receive oral tablets of Vemircopan. | Drug | Part 1: Vemircopan, Metformin and Rosuvastatin, Part 2: Vemircopan and LNG/EE-Containing OCs, Part 3: Vemircopan and Carbamazepine |
| RosuvastatinParticipants will receive oral coated tablets of Rosuvastatin. | Drug | Part 1: Vemircopan, Metformin and Rosuvastatin |
| MetforminParticipants will receive oral film-coated tablets of Metformin. | Drug | Part 1: Vemircopan, Metformin and Rosuvastatin |
| Levonorgestrel / Ethinyl EstradiolAlso: SIMPESSEParticipants will receive oral tablets of Levonorgestrel/ Ethinyl Estradiol. | Drug | Part 2: Vemircopan and LNG/EE-Containing OCs |
| CarbamazepineParticipants will receive oral chewable tablets of Carbamazepine. | Drug | Part 3: Vemircopan and Carbamazepine |
Primary outcome
Part 1: Maximum observed plasma (peak) concentration (Cmax) of Metformin
Time frame: Up to 48 hours post-dose
Cmax for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of metformin.
Part 1: AUC from time zero to the last quantifiable concentration (AUCt) of Metformin
Time frame: Up to 48 hours post-dose
AUCt for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of metformin.
Part 1: AUC from time zero extrapolated to infinity (AUC∞) of Metformin
Time frame: Up to 48 hours post-dose
Cmax for single-dose metformin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of metformin.
Part 1: Cmax of Rosuvastatin
Time frame: Up to 96 hours post-dose
Cmax for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of rosuvastatin.
Part 1: AUCt of Rosuvastatin
Time frame: Up to 96 hours post-dose
AUCt for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of rosuvastatin.
Part 1: AUC∞ of Rosuvastatin
Time frame: Up to 96 hours post-dose
Cmax for single-dose rosuvastatin without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of rosuvastatin.
Part 2: Cmax of LNG
Time frame: Up to 120 hours post-dose
Cmax for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of LNG.
Part 2: AUCt of LNG
Time frame: Up to 120 hours post-dose
AUCt for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of LNG.
Part 2: AUC∞ of LNG
Time frame: Up to 120 hours post-dose
Cmax for single-dose LNG without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of LNG.
Part 2: Cmax of EE
Time frame: Up to 120 hours post-dose
Cmax for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of EE.
Part 2: AUCt of EE
Time frame: Up to 120 hours post-dose
AUCt for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of EE.
Part 2: AUC∞ of EE
Time frame: Up to 120 hours post-dose
Cmax for single-dose EE without and with co-administration with vemircopan will be assessed to determine the effect of multiple doses of vemircopan on the single-dose PK of EE.
Part 3: Cmax of Vemircopan
Time frame: Up to 72 hours post-dose
Cmax for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on the single-dose PK of vemircopan.
Part 3: AUCt of Vemircopan
Time frame: Up to 72 hours post-dose
AUCt for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on the single-dose PK of vemircopan.
Part 3: AUC∞ of Vemircopan
Time frame: Up to 72 hours post-dose
Cmax for single-dose vemircopan without and with co-administration with carbamazepine will be assessed to determine the effect of multiple doses of carbamazepine on the single-dose PK of vemircopan.
40 secondary outcomes
Part 1: Number of participants with Treatment Emergent Adverse Events
Time frame: From Screening (Day -28 to Day -2) up to follow-up Visit or early discontinuation visit (approximately 57 days)
Part 2: Number of participants with Treatment Emergent Adverse Events
Time frame: From Screening (Day -28 to Day -2) up to follow-up Visit or early discontinuation visit (approximately 54 days)
Part 3: Number of participants with Treatment Emergent Adverse Events
Time frame: From Screening (Day -28 to Day -2) up to follow-up Visit or early discontinuation visit (approximately 63 days)
Part 1: Time corresponding to the occurrence of Cmax (tmax) of Metformin
Time frame: Up to 48 hours post-dose
Part 1: Apparent terminal elimination half-life (t½) of Metformin
Time frame: Up to 48 hours post-dose
Part 1: Terminal elimination rate constant (λz) of Metformin
Time frame: Up to 48 hours post-dose
Part 1: Volume of distribution (apparent) following extravascular administration (Vd/F) of Metformin
Time frame: Up to 48 hours post-dose
Part 1: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Metformin
Time frame: Up to 48 hours post-dose
Part 1: tmax of Rosuvastatin
Time frame: Up to 96 hours post-dose
Part 1: t½ of Rosuvastatin
Time frame: Up to 96 hours post-dose
Part 1: λz of Rosuvastatin
Time frame: Up to 96 hours post-dose
Part 1: Vd/F of Rosuvastatin
Time frame: Up to 96 hours post-dose
Part 1: CL/F of Rosuvastatin
Time frame: Up to 96 hours post-dose
Part 1: Cmax of Vemircopan
Time frame: Period 2: Days 4, 5 and 8
Part 1: AUC during a dosing interval at steady state (AUCtau) of Vemircopan
Time frame: Period 2: Days 4, 5 and 8
Part 1: tmax of Vemircopan
Time frame: Period 2: Days 4, 5 and 8
Part 1: Predose concentration prior to morning dose (Ctrough) of Vemircopan
Time frame: Period 2: Days 3, 4, 5 and 8
Part 2: tmax of LNG
Time frame: Up to 120 hours post-dose
Part 2: t½ of LNG
Time frame: Up to 120 hours post-dose
Part 2: λz of LNG
Time frame: Up to 120 hours post-dose
Part 2: Vd/F of LNG
Time frame: Up to 120 hours post-dose
Part 2: CL/F of LNG
Time frame: Up to 120 hours post-dose
Part 2: tmax of EE
Time frame: Up to 120 hours post-dose
Part 2: t½ of EE
Time frame: Up to 120 hours post-dose
Part 2: λz of EE
Time frame: Up to 120 hours post-dose
Part 2: Vd/F of EE
Time frame: Up to 120 hours post-dose
Part 2: CL/F of EE
Time frame: Up to 120 hours post-dose
Part 2: Cmax of Vemircopan
Time frame: Period 2: Days 4, and 5
Part 2: AUCtau of Vemircopan
Time frame: Period 2: Days 4, and 5
Part 2: tmax of Vemircopan
Time frame: Period 2: Days 4, and 5
Part 2: Ctrough of Vemircopan
Time frame: Period 2: Days 3, 4, and 5
Part 3: tmax of Vemircopan
Time frame: Up to 72 hours post-dose
Part 3: t½ of Vemircopan
Time frame: Up to 72 hours post-dose
Part 3: λz of Vemircopan
Time frame: Up to 72 hours post-dose
Part 3: Vd/F of Vemircopan
Time frame: Up to 72 hours post-dose
Part 3: CL/F of Vemircopan
Time frame: Up to 96 hours post-dose
Part 3: Cmax of Carbamazepine
Time frame: Period 2: Days 4, 18 and 19
Part 3: AUCtau of Carbamazepine
Time frame: Period 2: Days 4, 18 and 19
Part 3: tmax of Carbamazepine
Time frame: Period 2: Days 4, 18 and 19
Part 3: Ctrough of Carbamazepine
Time frame: Period 2: Days 18 and 19
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 12 Aug 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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 Vemircopan, Rosuvastatin and Metformin in people with Healthy Participants, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
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 3 inclusion and 7 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 12 Aug 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 States. 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?
Part 1: Maximum observed plasma (peak) concentration (Cmax) of Metformin (time frame: Up to 48 hours post-dose). The study lists 15 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 12 Aug 2025.