Clinical trial NCT04660890: A Study of the Cardiac Effects of ALXN2050 in Healthy Adults
Official title: A Multiple-Ascending-Dose, Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled Study to Evaluate the Effect of ALXN2050 on the QT Interval in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ALXN2050
Electrocardiogram
QT Interval
Concentration-QT
Factor D Inhibitor
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2020-12-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized, double-blind, double-dummy, placebo- and positive-controlled parallel study to evaluate the effect of ALXN2050 on the QT interval in healthy adult participants.

Detailed description: Participants randomized to the treatment arm will receive ALXN2050 in a multiple-ascending doses fashion over 3 periods (treatment sequence ABC). Participants randomized to the control arms will be further randomized to 1 of 2 treatment sequences (treatment sequence DEF or GHI) to receive placebo or active control over 3 periods.

Eligibility criteria: Inclusion Criteria:

1. Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.
2. No clinically significant history or presence of ECG abnormalities at screening.
3. Female participants must be of non-childbearing potential and need not employ a method of contraception.
4. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.

Exclusion Criteria:

1. Clinically significant laboratory abnormalities.
2. 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.
3. History or presence of drug or alcohol abuse within previous 2 years, current tobacco and/or nicotine user, or positive alcohol and/or drug screen at screening or Day -1 of Period 1.
4. History or presence of clinically significant seizures, head injury, or head trauma.
5. History of procedures that could alter absorption or excretion of orally administered drugs.
6. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
7. History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
8. Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1 or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.
9. Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, or receipt of blood products within 6 months prior to first dosing.
10. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer.

Primary outcomes:
measure: Placebo-corrected Change From Baseline QTc Intervals (ddQTc) For ALXN2050
timeFrame: Pre-dose through 24 hours post-dose
Secondary outcomes:
measure: Change From Baseline PR Interval (dPR) For ALXN2050
timeFrame: Pre-dose through 24 hours post-dose
measure: ddQTc For Moxifloxacin
timeFrame: Pre-dose through 24 hours post-dose
measure: Area Under The Plasma Concentration-time Curve During A Dosing Interval (tau) At Steady-state (AUCtau) For ALXN2050
timeFrame: Pre-dose through 24 hours post-dose
measure: Maximum Observed Plasma Concentration Following Multiple Dosing (Cmax,ss) For ALXN2050
timeFrame: Up to 24 hours postdose
measure: Time To Maximum Observed Plasma Concentration Following Multiple Dosing (Tmax,ss) For ALXN2050
timeFrame: Pre-dose through 24 hours post-dose
measure: Incidence Of Treatment-emergent Adverse Events
timeFrame: Day 1 (postdose) through follow-up (7 [+/- 2] days after last study drug administration)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Clinical Trial Site
state: Arizona
Study officials:
References: