Drug Interaction Study of ALXN2050 With Fluconazole and Rifampin in Healthy Adult Participants

Sponsor
Alexion Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04933682
Collaborator
(none)
16
1
2
1.4
11.6

Study Details

Study Description

Brief Summary

This is a 2-part, open label, fixed-sequence study to evaluate the potential drug interaction between ALXN2050 and fluconazole (Part 1), and between ALXN2050 and rifampin (Part 2) in healthy adult participants. Part 1 will be a 2-period, fixed-sequence study. Part 2 will be a single-period, fixed-sequence study.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This will be a 2-part, open-label, fixed-sequence study.This will be a 2-part, open-label, fixed-sequence study.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1 Two-Part Study to Evaluate the Potential Drug Interactions Between ALXN2050 and Fluconazole, and Between ALXN2050 and Rifampin in Healthy Adult Participants
Actual Study Start Date :
Jun 23, 2021
Actual Primary Completion Date :
Aug 4, 2021
Actual Study Completion Date :
Aug 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: ALXN2050 plus Fluconazole

Period 1: Participants will receive a single dose of ALXN2050 alone and in the presence of multiple doses of fluconazole. Period 2: Participants will receive multiple doses of ALXN2050 alone and in the presence of multiple doses of fluconazole. Scheduled pharmacokinetics (PK) blood samples for both ALXN2050 and fluconazole will be collected, with a washout period of at least 14 days between the last dose of fluconazole in Period 1 and the first dose of ALXN2050 in Period 2.

Drug: ALXN2050
Oral tablet.
Other Names:
  • ACH-0145228 (formerly)
  • Drug: Fluconazole
    Oral tablet.

    Experimental: Part 2: ALXN2050 plus Rifampin

    Participants will receive a single dose of ALXN2050 alone and in the presence of both single and multiple doses of rifampin. Scheduled PK blood samples for both ALXN2050 and rifampin will be collected.

    Drug: ALXN2050
    Oral tablet.
    Other Names:
  • ACH-0145228 (formerly)
  • Drug: Rifampin
    Oral capsule.

    Outcome Measures

    Primary Outcome Measures

    1. Part 1: Area Under The Concentration-time Curve From Time 0 To Infinity (AUC0-inf) For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole [Up to 72 hours postdose]

    2. Part 1: Maximum Observed Concentration (Cmax) For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole [Up to 72 hours postdose]

    3. Part 1: Time To Maximum Plasma Concentration (Tmax) For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole [Up to 72 hours postdose]

    4. Part 1: Area Under The Concentration-time Curve From Time 0 To The 12-hour Point (AUC0-12) For Multiple Doses Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole [Up to 72 hours postdose]

    5. Part 1: Cmax For Multiple Doses Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole [Up to 72 hours postdose]

    6. Part 1: Tmax For Multiple Doses Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole [Up to 72 hours postdose]

    7. Part 2: AUC0-inf For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed With A Single Dose Of Rifampin [Up to 72 hours postdose]

    8. Part 2: Cmax For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed With A Single Dose Of Rifampin [Up to 72 hours postdose]

    9. Part 2: Tmax For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed With A Single Dose Of Rifampin [Up to 72 hours postdose]

    10. Part 2: AUC0-inf For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Rifampin [Up to 72 hours postdose]

    11. Part 2: Cmax For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Rifampin [Up to 72 hours postdose]

    12. Part 2: Tmax For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Rifampin [Up to 72 hours postdose]

    Secondary Outcome Measures

    1. Part 1: Area Under The Concentration-time Curve From Time Zero To The 4-hour Time Point (AUC0-4) For ALXN2050 When Dosed In The Morning Versus In The Evening [Up to 12 hours postdose]

    2. Participants Experiencing Treatment-emergent Adverse Events [Up to 40 days postdose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:
    • Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles.

    • Body mass index within the range 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.

    Key Exclusion Criteria:
    • History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.

    • History of significant multiple and/or severe allergies.

    • Any previous procedure that could alter absorption or excretion of orally administered drugs.

    • Participation in another investigational drug or investigational device study within 5 half-lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.

    • Body temperature ≥ 38.0°Celsius, at Screening or prior to the first dose of study intervention.

    • History of drug or alcohol abuse within 2 years prior to the first dose of study intervention or positive drugs-of-abuse or alcohol screen at Screening or Day -1; current tobacco/nicotine user or smoker or a positive cotinine test at Screening.

    • Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention; receipt of blood products within 6 months prior to the first dose of study intervention.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Trial Site Tempe Arizona United States 85283

    Sponsors and Collaborators

    • Alexion Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alexion Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04933682
    Other Study ID Numbers:
    • ALXN2050-HV-105
    First Posted:
    Jun 22, 2021
    Last Update Posted:
    Dec 28, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alexion Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 28, 2021