Study Results
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Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2019-12-22
2020-04-16
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
NONE
Study Groups
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Part 1: ACH-0145228, Midazolam, and Digoxin
Period 1: Participants received single doses of midazolam and digoxin.
Period 2: Participants received ACH-0145228 twice daily, in addition to coadministration with single doses of midazolam and digoxin.
Scheduled pharmacokinetics (PK) blood and urine samples were collected, with a washout period of at least 7 days between collection of the last PK blood sample in Period 1 and the first dose of ACH-0145228 in Period 2.
ACH-0145228
ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules.
Midazolam
Midazolam was dosed at 2 mg (1 milliliter \[mL\] of a 2 mg/mL syrup).
Digoxin
Digoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet.
Part 2: ACH-0145228 and Itraconazole
Period 1: Participants received a single dose of ACH-0145228.
Period 2: Participants received itraconazole once daily, in addition to coadministration with a single dose of ACH-0145228.
Scheduled PK blood samples were collected, with a washout period of at least 2 days between collection of the last PK blood sample in Period 1 and the first dose of itraconazole in Period 2.
ACH-0145228
ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules.
Itraconazole
Itraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution).
Interventions
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ACH-0145228
ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules.
Midazolam
Midazolam was dosed at 2 mg (1 milliliter \[mL\] of a 2 mg/mL syrup).
Digoxin
Digoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet.
Itraconazole
Itraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. No clinically significant history or presence of electrocardiogram abnormalities at screening and prior to first dosing in Period 1.
3. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
4. Female participants must be of non-childbearing potential and need not employ a 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/nicotine user, or positive for 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. A history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
7. Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1.
8. 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.
9. 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.
10. History or presence of any risk factors for Torsades de Pointes.
18 Years
55 Years
ALL
Yes
Sponsors
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Achillion, a wholly owned subsidiary of Alexion
INDUSTRY
Celerion
INDUSTRY
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Study Site
Tempe, Arizona, United States
Countries
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Other Identifiers
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CA28776
Identifier Type: OTHER
Identifier Source: secondary_id
ACH228-003
Identifier Type: -
Identifier Source: org_study_id
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