A Study of the Cardiac Effects of ALXN2050 in Healthy Adults
NCT ID: NCT04660890
Last Updated: 2021-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2020-12-12
2021-03-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Treatment Arm (ABC)
Treatment Sequence ABC - Participants will receive all 3 doses of ALXN2050 in a multiple-ascending fashion over 3 periods:
Treatment A (Period 1): ALXN2050 Dose 120 milligrams (mg) and moxifloxacin-matching placebo.
Treatment B (Period 2): ALXN2050 Dose 240 mg and moxifloxacin-matching placebo.
Treatment C (Period 3): ALXN2050 Dose 360 mg and moxifloxacin-matching placebo.
ALXN2050
ALXN2050 will be administered orally twice daily as powder-in-capsule.
Moxifloxacin-matching Placebo
Moxifloxacin-matching placebo will be administered as a single oral dose.
Control Arm (DEF)
Treatment Sequence DEF - Participants will receive ALXN2050-matching placebo over 3 periods:
Treatment D (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
Treatment E (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin.
Treatment F (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
ALXN2050-matching Placebo
ALXN2050-matching placebo will be administered orally twice daily as placebo powder-in-capsule.
Moxifloxacin
Moxifloxacin will be administered as a single oral dose.
Moxifloxacin-matching Placebo
Moxifloxacin-matching placebo will be administered as a single oral dose.
Control Arm (GHI)
Treatment Sequence GHI - Participants will receive ALXN2050-matching placebo over 3 periods:
Treatment G (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin.
Treatment H (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
Treatment I (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin.
ALXN2050-matching Placebo
ALXN2050-matching placebo will be administered orally twice daily as placebo powder-in-capsule.
Moxifloxacin
Moxifloxacin will be administered as a single oral dose.
Moxifloxacin-matching Placebo
Moxifloxacin-matching placebo will be administered as a single oral dose.
Interventions
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ALXN2050
ALXN2050 will be administered orally twice daily as powder-in-capsule.
ALXN2050-matching Placebo
ALXN2050-matching placebo will be administered orally twice daily as placebo powder-in-capsule.
Moxifloxacin
Moxifloxacin will be administered as a single oral dose.
Moxifloxacin-matching Placebo
Moxifloxacin-matching placebo will be administered as a single oral dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
Yes
Sponsors
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Celerion
INDUSTRY
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Tempe, Arizona, United States
Countries
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Other Identifiers
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ALXN2050-HV-107
Identifier Type: -
Identifier Source: org_study_id