Bioequivalence Between 180 mg and 60 mg ALXN2050 Tablets and Food Effect on ALXN2050 Pharmacokinetics
NCT ID: NCT05578846
Last Updated: 2025-02-14
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
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2022-10-13
2023-01-05
Brief Summary
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Detailed Description
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Screening of participants will occur within 28 days prior to the first dose of study intervention.
The study will comprise of 3 Treatment Periods: Treatment period 1, Treatment period 2, Treatment period 3. There will be a washout period of at least 4 days between the ALXN2050 dose in each treatment period.
Participants will be enrolled and will be randomized 1:1:1:1:1:1 to receive one of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA).
On the morning of Day 1 of each of the 3 periods, participants will receive one of the following treatments as per the randomization scheme.
* Treatment A: Dose B of ALXN2050 tablet under fasted conditions
* Treatment B: A single Dose A dose of ALXN2050 tablet under fasted conditions
* Treatment C: A single Dose A dose of ALXN2050 tablet with a high-fat meal
Duration of study conduct (screening to follow-up): approximately 47 days.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Treatment sequence ABC
Participants will be administered Treatment A (3 X Dose B of ALXN2050 tablet under fasted conditions), Treatment B (single Dose A of ALXN2050 tablet under fasted conditions) and Treatment C (single Dose A of ALXN2050 tablet with a high-fat meal) on Day 1 of each treatment period. Washout period of at least 4 days between the ALXN2050 dose in each treatment period.
Treatment A
Participants will receive single Dose A dose of ALXN2050 tablet (3 × Dose B) orally under fasted conditions.
Treatment B
Participant will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally under fasted conditions.
Treatment C
Participants will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally with a high-fat meal.
Treatment sequence ACB
Participants will be administered Treatment A (3 X Dose B of ALXN2050 tablet under fasted conditions), Treatment C (single Dose A of ALXN2050 tablet with a high-fat meal) and Treatment B (single Dose A of ALXN2050 tablet under fasted conditions) on Day 1 of each treatment period. Washout period of at least 4 days between the ALXN2050 dose in each treatment period.
Treatment A
Participants will receive single Dose A dose of ALXN2050 tablet (3 × Dose B) orally under fasted conditions.
Treatment B
Participant will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally under fasted conditions.
Treatment C
Participants will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally with a high-fat meal.
Treatment sequence BAC
Participants will be administered Treatment B (single Dose A of ALXN2050 tablet under fasted conditions), Treatment A (3 X Dose B of ALXN2050 tablet under fasted conditions) and Treatment C (single Dose A of ALXN2050 tablet with a high-fat meal) and on Day 1 of each treatment period. Washout period of at least 4 days between the ALXN2050 dose in each treatment period.
Treatment A
Participants will receive single Dose A dose of ALXN2050 tablet (3 × Dose B) orally under fasted conditions.
Treatment B
Participant will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally under fasted conditions.
Treatment C
Participants will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally with a high-fat meal.
Treatment sequence BCA
Participants will be administered Treatment B (single Dose A of ALXN2050 tablet under fasted conditions), Treatment C (single Dose A of ALXN2050 tablet with a high-fat meal) and Treatment A (3 X Dose B of ALXN2050 tablet under fasted conditions) and on Day 1 of each treatment period. Washout period of at least 4 days between the ALXN2050 dose in each treatment period.
Treatment A
Participants will receive single Dose A dose of ALXN2050 tablet (3 × Dose B) orally under fasted conditions.
Treatment B
Participant will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally under fasted conditions.
Treatment C
Participants will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally with a high-fat meal.
Treatment sequence CAB
Participants will be administered Treatment C (single Dose A of ALXN2050 tablet with a high-fat meal), Treatment A (3 X Dose B of ALXN2050 tablet under fasted conditions) and Treatment B (single Dose A of ALXN2050 tablet under fasted conditions) on Day 1 of each treatment period. Washout period of at least 4 days between the ALXN2050 dose in each treatment period.
Treatment A
Participants will receive single Dose A dose of ALXN2050 tablet (3 × Dose B) orally under fasted conditions.
Treatment B
Participant will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally under fasted conditions.
Treatment C
Participants will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally with a high-fat meal.
Treatment sequence CBA
Participants will be administered Treatment C (single Dose A of ALXN2050 tablet with a high-fat meal), Treatment B (single Dose A of ALXN2050 tablet under fasted conditions) and Treatment A (3 X Dose B of ALXN2050 tablet under fasted conditions) on Day 1 of each treatment period. Washout period of at least 4 days between the ALXN2050 dose in each treatment period.
Treatment A
Participants will receive single Dose A dose of ALXN2050 tablet (3 × Dose B) orally under fasted conditions.
Treatment B
Participant will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally under fasted conditions.
Treatment C
Participants will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally with a high-fat meal.
Interventions
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Treatment A
Participants will receive single Dose A dose of ALXN2050 tablet (3 × Dose B) orally under fasted conditions.
Treatment B
Participant will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally under fasted conditions.
Treatment C
Participants will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally with a high-fat meal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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.
4. Female participant of childbearing potential and male participants must follow protocol-specified contraception guidance.
Exclusion Criteria
2. History of meningococcal infection.
3. History of clinically significant hypersensitivity or idiosyncratic reaction to the study interventions or related compounds.
4. 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.
5. History of significant multiple and/or severe allergies
6. History of seizures.
7. History of head injury, or head trauma requiring medical evaluation.
8. History of drug or alcohol abuse
9. Current tobacco users or smoker
10. 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.
11. Any major surgery within 8 weeks of Screening.
12. 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.
13. 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.
14. 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Parexel
INDUSTRY
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
Baltimore, Maryland, United States
Countries
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Related Links
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Other Identifiers
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ALXN2050-HV-112
Identifier Type: -
Identifier Source: org_study_id
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