Does breakfast change how this heart drug works? small study investigates
NCT ID NCT04958135
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tested how a high-fat, high-calorie meal affects the way the body processes acoramidis, a drug being developed for a rare heart condition. Eighteen healthy adults took a single dose of the drug either with or without food. The goal was to see if food changes the amount of drug in the blood, which could guide future dosing instructions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- acoramidis
- What this could lead to
- If successful, this study could help determine the best way to take acoramidis (with or without food) for future patients.
- What could go wrong
- This is a very early, small study in healthy people, not patients. It only looks at how food affects drug levels, not whether the drug works or is safe long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
18 people
The number who actually took part.
- Started
-
May 2021
- Finished
-
Aug 2021
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Participants who are healthy as determined by medical evaluation with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluation (hematology, chemistry, urinalysis, and coagulation) that are reasonably likely to interfere with the participant's participation in or ability to complete the study, or to potentially confound interpretation of study results, as assessed by the Investigator. * Body weight ≥ 50 to ≤ 100 kilograms (kg) and body mass index within the range ≥ 18 to \< 32 kg/meter squared for all participants. Key Exclusion Criteria: * Evidence of any clinically significant deviation from normal in clinical laboratory evaluations, as determined by the Investigator or designee. * History of any medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, 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. * History or presence of clinically significant hypersensitivity or idiosyncratic reaction to the study interventions or related compounds. History of allergy to other drugs or food will be evaluated by the Investigator or designee on a case by case basis and a decision to enroll will be made by the Investigator or designee. * Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric disease or diseases. * Disorders of central nervous system, psychiatric disorders, behavioral disturbances (for example, cerebrovascular events, depression, post-traumatic stress disorder, anxiety, bipolar disorder, severe migraine, Parkinson's disease). * Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study. * Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to the first dose of study intervention. * Female participants who are pregnant, as evidenced by a positive serum pregnancy test result at Screening, or breastfeeding. * Prior exposure to ALXN2060. * Major surgery or hospitalization within 90 days prior to dosing on Day 1. * Use of tobacco in any form (for example, smoking, chewing or vaping), other nicotine-containing products in any form (for example, gum, patch, electronic cigarettes, or vapes), or any recreational inhalational product within 6 months prior to the planned first day of dosing. * Use of known drugs of abuse within 6 months prior to the planned first day of dosing. * Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \> 14 units/week for males or \> 7 units/week for females. One unit is equivalent to 8 grams of alcohol: a half pint (\~240 milliliters \[mL\]) of beer, one \~4 ounce glass (125 mL) of wine, or 1 (25 mL) measure of spirits. * Positive urine drug toxicology screen at Screening or check-in (Day -1). * Alcohol consumption within 24 hours prior to study intervention administration or positive alcohol breath test at Screening or check-in (Day -1). * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Celerion
Lincoln, Nebraska, 68502, United States
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