Healthy
Conditions
Keywords
ALXN2050, Fluconazole, Rifampin, Drug-Drug Interaction
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.
Interventions
Sponsors
Alexion Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
This will be a 2-part, open-label, fixed-sequence study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Participants Experiencing Treatment-emergent Adverse Events | Up to 40 days postdose |
| 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 |
Countries
United States
Outcome results
None listed