A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants
NCT ID: NCT04551586
Last Updated: 2021-12-28
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2020-06-26
2020-10-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sequence 1
Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows:
Period 1: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted).
Period 2: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed).
Period 3: ACH-0145228 as power-in-capsule under fasted conditions (reference).
There will be a washout period of at least 5 days between each ACH-0145228 dosing.
ACH-0145228: Immediate Release
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
ACH-0145228: Powder-in-capsule
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
Sequence 2
Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows:
Period 1: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed).
Period 2: ACH-0145228 as power-in-capsule under fasted conditions (reference).
Period 3: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted).
There will be a washout period of at least 5 days between each ACH-0145228 dosing.
ACH-0145228: Immediate Release
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
ACH-0145228: Powder-in-capsule
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
Sequence 3
Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows:
Period 1: ACH-0145228 as power-in-capsule under fasted conditions (reference).
Period 2: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted).
Period 3: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed).
There will be a washout period of at least 5 days between each ACH-0145228 dosing.
ACH-0145228: Immediate Release
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
ACH-0145228: Powder-in-capsule
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ACH-0145228: Immediate Release
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
ACH-0145228: Powder-in-capsule
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. No clinically significant history or presence of electrocardiogram findings at screening.
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 user, and positive drugs-of-abuse screen and alcohol 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. A 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. Is a female of childbearing potential.
10. Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, and receipt of blood products within 6 months prior to first dosing.
11. 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
Meet the organizations funding or collaborating on the study and learn about their roles.
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Trial Site
Lincoln, Nebraska, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACH228-004
Identifier Type: -
Identifier Source: org_study_id