HealthyPhase 1NCT04958135
Study to Assess the Effect of Food on a Single Dose of Acoramidis in Healthy Adult Participants
A Phase 1 study testing Acoramidis in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of a high-fat, high-caloric meal on the pharmacokinetics (PK) of acoramidis in healthy adult participants following an oral single dose administration of acoramidis. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Acoramidis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2021to 4 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-Label, 2-Period, 2-Sequence, 2-Way Crossover Study to Assess the Effect of Food on the Single Dose Pharmacokinetics of Acoramidis in Healthy Participants
The purpose of this study is to determine the effect of a high-fat, high-caloric meal on the pharmacokinetics (PK) of acoramidis in healthy adult participants following an oral single dose administration of acoramidis. Blood sampling for PK assessment will include measures for acoramidis and its metabolite, acoramidis acyl glucuronide (acoramidis-AG).
- Conditions
- Healthy
- Being tested
- Acoramidis
- Keywords
- Acoramidis, ALXN2060, AG10, Pharmacokinetics, Food Effect, Crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcoramidisDrug
Also called ALXN2060, AG10
Film-coated immediate release oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Acoramidis | Experimental | Participants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows:
Period 1: Acoramidis as an immediate-release tablet under fasted conditions.
Period 2: Acoramidis as an immediate-release tablet under fed conditions.
There will be a washout period of at least 14 days between acoramidis dosing. Receives: Drug: Acoramidis |
| Sequence 2: Acoramidis | Experimental | Participants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows:
Period 1: Acoramidis as an immediate-release tablet under fed conditions.
Period 2: Acoramidis as an immediate-release tablet under fasted conditions.
There will be a washout period of at least 14 days between acoramidis dosing. Receives: Drug: Acoramidis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) Of Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions
Measured: Up to 336 hours postdose
Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUC0-t) For Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions
Measured: Up to 336 hours postdose
Area Under The Plasma Concentration Versus Time Curve From Zero To Infinity (AUC0-inf) For Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions
Measured: Up to 336 hours postdose
Secondary outcomes (3)
Cmax Of Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions
Measured: Up to 336 hours postdose
AUC0-t For Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions
Measured: Up to 336 hours postdose
AUC0-inf For Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions
Measured: Up to 336 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start30 May 2021
- Primary completion4 Aug 2021
- Study completion4 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a balanced, 2-period, 2-sequence, 2-way crossover study in healthy participants. All participants will receive 1 treatment in each period.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958135
- Sponsor's protocol ID
- ALXN2060-HV-101
- Status last verified
- Mar 2026
- First submitted
- 1 Jul 2021
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, 2-Period, 2-Sequence, 2-Way Crossover Study to Assess the Effect of Food on the Single Dose Pharmacokinetics of Acoramidis in Healthy Participants
- ClinicalTrials.gov ID
- NCT04958135
- Acronym / sponsor ID
- ALXN2060-HV-101
- Conditions
- Healthy
- Keywords
- Acoramidis, ALXN2060, AG10, Pharmacokinetics, Food Effect, Crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 30 May 2021 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of a high-fat, high-caloric meal on the pharmacokinetics (PK) of acoramidis in healthy adult participants following an oral single dose administration of acoramidis. Blood sampling for PK assessment will include measures for acoramidis and its metabolite, acoramidis acyl glucuronide (acoramidis-AG).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a balanced, 2-period, 2-sequence, 2-way crossover study in healthy participants. All participants will receive 1 treatment in each period.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Acoramidis | Experimental | Drug: AcoramidisParticipants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows: Period 1: Acoramidis as an immediate-release tablet under fasted conditions. Period 2: Acoramidis as an immediate-release tablet under fed conditions. There will be a washout period of at least 14 days between acoramidis dosing. |
| Sequence 2: Acoramidis | Experimental | Drug: AcoramidisParticipants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows: Period 1: Acoramidis as an immediate-release tablet under fed conditions. Period 2: Acoramidis as an immediate-release tablet under fasted conditions. There will be a washout period of at least 14 days between acoramidis dosing. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcoramidisAlso: ALXN2060, AG10Film-coated immediate release oral tablet. | Drug | Sequence 1: Acoramidis, Sequence 2: Acoramidis |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) Of Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions
Time frame: Up to 336 hours postdose
Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUC0-t) For Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions
Time frame: Up to 336 hours postdose
Area Under The Plasma Concentration Versus Time Curve From Zero To Infinity (AUC0-inf) For Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions
Time frame: Up to 336 hours postdose
3 secondary outcomes
Cmax Of Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions
Time frame: Up to 336 hours postdose
AUC0-t For Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions
Time frame: Up to 336 hours postdose
AUC0-inf For Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions
Time frame: Up to 336 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acoramidis in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) Of Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions (time frame: Up to 336 hours postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.