Study to Assess the Effect of Food on a Single Dose of Acoramidis in Healthy Adult Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04958135
• Other study ID #: ALXN2060-HV-101
• Status: Completed
• Phase: Phase 1
• Start date: June 16, 2021
• Est. completion date: August 17, 2021

Study information

• Verified date: September 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Blood sampling for PK assessment will include measures for acoramidis and its metabolite, acoramidis acyl glucuronide (acoramidis-AG).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 17, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Acoramidis
Film-coated immediate release oral tablet.

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) Of Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions		Up to 336 hours postdose
Primary	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		Up to 336 hours postdose
Primary	Area Under The Plasma Concentration Versus Time Curve From Zero To Infinity (AUC0-inf) For Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions		Up to 336 hours postdose
Secondary	Cmax Of Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions		Up to 336 hours postdose
Secondary	AUC0-t For Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions		Up to 336 hours postdose
Secondary	AUC0-inf For Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions		Up to 336 hours postdose