Bioequivalence Between 180 mg and 60 mg ALXN2050 Tablets and Food Effect on ALXN2050 Pharmacokinetics
Study Identifier:
ALXN2050-HV-112
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Other
Study Drug
- Drug: Treatment A
- Drug: Treatment B
- Drug: Treatment C
Date
Oct 2022 - Jan 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
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, neurological examination, vital signs, 12-lead ECG, and screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), that are reasonably likely to interfere with participation in or ability to complete the study, or to potentially confound interpretation of study results, as assessed by the Investigator or designee and Alexion Medical Monitor.
- QT interval corrected using Fridericia's formula (QTcF) \< 450 msec; QRS interval ≤ 110 msec; if \> 110 msec, result will be confirmed by a manual over read; PR interval \> 120 msec and \< 220 msec at Screening
- Body mass index (BMI) within the range 18.0 to 32.0 kg/m2, inclusive, with a minimum body weight of 50.0 kg at Screening.
- Female participant of childbearing potential and male participants must follow protocol-specified contraception guidance.
Exclusion Criteria
- History of any medical (eg, cardiac, pulmonary, renal, or oncologic) 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 of meningococcal infection.
- History of clinically significant hypersensitivity or idiosyncratic reaction to the study interventions or related compounds.
- History of clinically significant hypersensitivity reactions to commonly used antibacterial agents, including beta lactams, penicillin, aminopenicillins, fluoroquinolones, cephalosporins, and carbapenems, which in the opinion of the Investigator would make it difficult to properly provide either empiric antibiotic therapy or treat an active infection.
- History of significant multiple and/or severe allergies
- History of seizures.
- History of head injury, or head trauma requiring medical evaluation.
- History of drug or alcohol abuse
- Current tobacco users or smoker
- Diseases or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs. Any previous procedure, including history of stomach or intestinal surgery or resection, transjugular intrahepatic portosystemic shunts, or surgical shunt, that could alter absorption or excretion of orally administered drugs. Appendectomy, cholecystectomy, and hernia repair will be allowed if they were not associated with complications.
- Any major surgery within 8 weeks of Screening.
- Donation of whole blood from 3 months prior to first dose of study intervention or of plasma from 30 days prior to the first dose of study intervention.
- History of malignancy within 5 years prior of Screening, with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
- Evidence of human immunodeficiency virus (HIV antibody positive) infection at screening.
- 18\. Evidence of hepatitis B (positive hepatitis surface antigen \[HBsAg\]) or positive core antibody (anti-HBc) with negative surface antibody \[anti-HBs\]) or hepatitis C viral infection (HCV antibody positive) at screening.
- 19\. Female participants who have a positive pregnancy test. 20. Vital signs out of the normal range as determined by the Investigator including body temperature ≥ 38°C.
Sex
Female & Male
Age
18 - 55 Years
Study Details
Medical Condition
- Other
Study Drug
- Drug: Treatment A
- Drug: Treatment B
- Drug: Treatment C
Date
Oct 2022 - Jan 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years years
Requirements Information
Inclusion and Exclusion Criteria
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, neurological examination, vital signs, 12-lead ECG, and screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), that are reasonably likely to interfere with participation in or ability to complete the study, or to potentially confound interpretation of study results, as assessed by the Investigator or designee and Alexion Medical Monitor.
- QT interval corrected using Fridericia's formula (QTcF) \< 450 msec; QRS interval ≤ 110 msec; if \> 110 msec, result will be confirmed by a manual over read; PR interval \> 120 msec and \< 220 msec at Screening
- Body mass index (BMI) within the range 18.0 to 32.0 kg/m2, inclusive, with a minimum body weight of 50.0 kg at Screening.
- Female participant of childbearing potential and male participants must follow protocol-specified contraception guidance.
Exclusion Criteria
- History of any medical (eg, cardiac, pulmonary, renal, or oncologic) 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 of meningococcal infection.
- History of clinically significant hypersensitivity or idiosyncratic reaction to the study interventions or related compounds.
- History of clinically significant hypersensitivity reactions to commonly used antibacterial agents, including beta lactams, penicillin, aminopenicillins, fluoroquinolones, cephalosporins, and carbapenems, which in the opinion of the Investigator would make it difficult to properly provide either empiric antibiotic therapy or treat an active infection.
- History of significant multiple and/or severe allergies
- History of seizures.
- History of head injury, or head trauma requiring medical evaluation.
- History of drug or alcohol abuse
- Current tobacco users or smoker
- Diseases or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs. Any previous procedure, including history of stomach or intestinal surgery or resection, transjugular intrahepatic portosystemic shunts, or surgical shunt, that could alter absorption or excretion of orally administered drugs. Appendectomy, cholecystectomy, and hernia repair will be allowed if they were not associated with complications.
- Any major surgery within 8 weeks of Screening.
- Donation of whole blood from 3 months prior to first dose of study intervention or of plasma from 30 days prior to the first dose of study intervention.
- History of malignancy within 5 years prior of Screening, with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
- Evidence of human immunodeficiency virus (HIV antibody positive) infection at screening.
- 18\. Evidence of hepatitis B (positive hepatitis surface antigen \[HBsAg\]) or positive core antibody (anti-HBc) with negative surface antibody \[anti-HBs\]) or hepatitis C viral infection (HCV antibody positive) at screening.
- 19\. Female participants who have a positive pregnancy test. 20. Vital signs out of the normal range as determined by the Investigator including body temperature ≥ 38°C.
Protocol Summary
This study will assess the Bioequivalence between 180 mg and 60 mg ALXN2050 Tablets and the Effect of Food on ALXN2050 Pharmacokinetics.
Trial Locations
Location
Status
Location
Research Site
Baltimore, Maryland, United States, 21225
Status
N/A