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
28 participants
INTERVENTIONAL
2017-11-28
2018-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Cohort 1: 40 mg ALXN2050/Placebo
Participants randomized to receive ALXN2050 or placebo on Day 1.
ALXN2050
Powder-in-capsule (PIC).
Placebo
PIC.
Cohort 2: 80 mg ALXN2050/Placebo
Participants randomized to receive ALXN2050 or placebo on Day 1.
ALXN2050
Powder-in-capsule (PIC).
Placebo
PIC.
Cohort 3: 120 mg ALXN2050/Placebo
Participants randomized to receive ALXN2050 or placebo on Day 1.
ALXN2050
Powder-in-capsule (PIC).
Placebo
PIC.
Interventions
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ALXN2050
Powder-in-capsule (PIC).
Placebo
PIC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Had a body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.
* Female participant of nonchildbearing potential.
* Male participant agreed to abstinence or use of a highly effective form of contraception.
Exclusion Criteria
* Had any condition possibly affecting drug absorption.
* Had a body temperature greater than or equal to 38°Celsius on Day -1 or Day 1, Hour 0; had a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration.
* Had a positive urine drug screen at Screening or Day -1; was a current tobacco/nicotine user or smoker; had consumed any alcohol within 72 hours before first study drug administration or had a history of regular alcohol consumption within 6 months of Screening.
* Had participated in a clinical study within 30 days prior to first study drug administration
* Had clinically significant laboratory abnormalities,
* Had donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration; had received a blood transfusion or blood products within 6 months prior to first study drug administration.
* Had a clinically significant history of drug allergy.
25 Years
55 Years
ALL
Yes
Sponsors
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Achillion, a wholly owned subsidiary of Alexion
INDUSTRY
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Auckland, , New Zealand
Countries
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Other Identifiers
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ACTRN12617001521314
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1203-1371
Identifier Type: OTHER
Identifier Source: secondary_id
ACH228-001
Identifier Type: -
Identifier Source: org_study_id
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