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Completed

NCT Number: NCT06071442

Potential Drug Interaction Study Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel/Ethinyl Estradiol-containing Oral Contraceptives, and Carbamazepine

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Brooklyn, Maryland, 21225, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Vemircopan

Drug

Participants will receive oral tablets of Vemircopan.

Other names: ALXN2050

Rosuvastatin

Drug

Participants will receive oral coated tablets of Rosuvastatin.

metformin

Drug

Participants will receive oral film-coated tablets of Metformin.

Levonorgestrel / Ethinyl Estradiol

Drug

Participants will receive oral tablets of Levonorgestrel/ Ethinyl Estradiol.

Other names: SIMPESSE

carbamazepine

Drug

Participants will receive oral chewable tablets of Carbamazepine.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Secondary outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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)

    The safety and tolerability of multiple doses of vemircopan when co-administered with multiple doses of carbamazepine will be assessed.

  4. Part 1: Time corresponding to the occurrence of Cmax (tmax) of Metformin

    Time frame: Up to 48 hours post-dose

    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.

  5. Part 1: Apparent terminal elimination half-life (t½) of Metformin

    Time frame: Up to 48 hours post-dose

    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.

  6. Part 1: Terminal elimination rate constant (λz) of Metformin

    Time frame: Up to 48 hours post-dose

    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.

  7. Part 1: Volume of distribution (apparent) following extravascular administration (Vd/F) of Metformin

    Time frame: Up to 48 hours post-dose

    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.

  8. 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

    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.

  9. Part 1: tmax of Rosuvastatin

    Time frame: Up to 96 hours post-dose

    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.

  10. Part 1: t½ of Rosuvastatin

    Time frame: Up to 96 hours post-dose

    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.

  11. Part 1: λz of Rosuvastatin

    Time frame: Up to 96 hours post-dose

    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.

  12. Part 1: Vd/F of Rosuvastatin

    Time frame: Up to 96 hours post-dose

    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.

  13. Part 1: CL/F of Rosuvastatin

    Time frame: Up to 96 hours post-dose

    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.

  14. Part 1: Cmax of Vemircopan

    Time frame: Period 2: Days 4, 5 and 8

    Cmax of vermircopan after multiple twice daily doses will be assessed.

  15. Part 1: AUC during a dosing interval at steady state (AUCtau) of Vemircopan

    Time frame: Period 2: Days 4, 5 and 8

    AUCtau of vermircopan after multiple twice daily doses will be assessed.

  16. Part 1: tmax of Vemircopan

    Time frame: Period 2: Days 4, 5 and 8

    tmax of vermircopan after multiple twice daily doses will be assessed.

  17. Part 1: Predose concentration prior to morning dose (Ctrough) of Vemircopan

    Time frame: Period 2: Days 3, 4, 5 and 8

    Ctrough of vermircopan after multiple twice daily doses will be assessed.

  18. Part 2: tmax of LNG

    Time frame: Up to 120 hours post-dose

    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.

  19. Part 2: t½ of LNG

    Time frame: Up to 120 hours post-dose

    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.

  20. Part 2: λz of LNG

    Time frame: Up to 120 hours post-dose

    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.

  21. Part 2: Vd/F of LNG

    Time frame: Up to 120 hours post-dose

    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.

  22. Part 2: CL/F of LNG

    Time frame: Up to 120 hours post-dose

    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.

  23. Part 2: tmax of EE

    Time frame: Up to 120 hours post-dose

    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.

  24. Part 2: t½ of EE

    Time frame: Up to 120 hours post-dose

    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.

  25. Part 2: λz of EE

    Time frame: Up to 120 hours post-dose

    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.

  26. Part 2: Vd/F of EE

    Time frame: Up to 120 hours post-dose

    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.

  27. Part 2: CL/F of EE

    Time frame: Up to 120 hours post-dose

    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.

  28. Part 2: Cmax of Vemircopan

    Time frame: Period 2: Days 4, and 5

    Cmax of vermircopan after multiple twice daily doses will be assessed.

  29. Part 2: AUCtau of Vemircopan

    Time frame: Period 2: Days 4, and 5

    AUCtau of vermircopan after multiple twice daily doses will be assessed.

  30. Part 2: tmax of Vemircopan

    Time frame: Period 2: Days 4, and 5

    tmax of vermircopan after multiple twice daily doses will be assessed.

  31. Part 2: Ctrough of Vemircopan

    Time frame: Period 2: Days 3, 4, and 5

    Ctrough of vermircopan after multiple twice daily doses will be assessed.

  32. Part 3: tmax of Vemircopan

    Time frame: Up to 72 hours post-dose

    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.

  33. Part 3: t½ of Vemircopan

    Time frame: Up to 72 hours post-dose

    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.

  34. Part 3: λz of Vemircopan

    Time frame: Up to 72 hours post-dose

    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.

  35. Part 3: Vd/F of Vemircopan

    Time frame: Up to 72 hours post-dose

    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.

  36. Part 3: CL/F of Vemircopan

    Time frame: Up to 96 hours post-dose

    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.

  37. Part 3: Cmax of Carbamazepine

    Time frame: Period 2: Days 4, 18 and 19

    Cmax of carbamazepine after multiple twice daily doses will be assessed.

  38. Part 3: AUCtau of Carbamazepine

    Time frame: Period 2: Days 4, 18 and 19

    AUCtau of carbamazepine after multiple twice daily doses will be assessed.

  39. Part 3: tmax of Carbamazepine

    Time frame: Period 2: Days 4, 18 and 19

    tmax of carbamazepine after multiple twice daily doses will be assessed.

  40. Part 3: Ctrough of Carbamazepine

    Time frame: Period 2: Days 18 and 19

    Ctrough of carbamazepine after multiple twice daily doses will be assessed.

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2023
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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