Clinical trial NCT04933682: Drug Interaction Study of ALXN2050 With Fluconazole and Rifampin in Healthy Adult Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ALXN2050
Fluconazole
Rifampin
Drug-Drug Interaction
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a 2-part, open-label, fixed-sequence study.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Up to 72 hours postdose
measure: 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
timeFrame: Up to 72 hours postdose
measure: 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
timeFrame: Up to 72 hours postdose
measure: 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
timeFrame: Up to 72 hours postdose
measure: Part 1: Cmax For Multiple Doses Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole
timeFrame: Up to 72 hours postdose
measure: Part 1: Tmax For Multiple Doses Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole
timeFrame: Up to 72 hours postdose
measure: Part 2: AUC0-inf For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed With A Single Dose Of Rifampin
timeFrame: Up to 72 hours postdose
measure: Part 2: Cmax For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed With A Single Dose Of Rifampin
timeFrame: Up to 72 hours postdose
measure: Part 2: Tmax For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed With A Single Dose Of Rifampin
timeFrame: Up to 72 hours postdose
measure: Part 2: AUC0-inf For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Rifampin
timeFrame: Up to 72 hours postdose
measure: Part 2: Cmax For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Rifampin
timeFrame: Up to 72 hours postdose
measure: Part 2: Tmax For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Rifampin
timeFrame: Up to 72 hours postdose
Secondary outcomes:
measure: 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
timeFrame: Up to 12 hours postdose
measure: Participants Experiencing Treatment-emergent Adverse Events
timeFrame: Up to 40 days postdose
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Clinical Trial Site
state: Arizona
Study officials:
References: