Bioequivalence Between 180 mg and 60 mg ALXN2050 Tablets and Food Effect on ALXN2050 Pharmacokinetics

NCT05578846 | Completed Phase 1 FDA Drug

• 1 other identifier: ALXN2050-HV-112
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the Bioequivalence between 180 mg and 60 mg ALXN2050 Tablets and the Effect of Food on ALXN2050 Pharmacokinetics.

Conditions

Healthy Adult Participants

Keywords

Bioequivalence; Effect of Food

Outcome Measures

Primary Outcomes (9)

• Cmax (Maximum observed plasma (peak) concentration of the drug)

  To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet.

  Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days)

• AUCt (Area under the concentration time curve from time zero to the last quantifiable concentration)

  To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet.

  Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days)

• AUC∞ (Area under the concentration time curve from time zero extrapolated to infinity)

  To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet.

  Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days)

• Tmax (Time corresponding to occurrence of Cmax)

  To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet.

  Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days)

• tlag (Time prior to the first measurable (non zero) concentration)

  To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet.

  Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days)

• t½ (Apparent terminal elimination half-life)

  To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet.

  Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days)

• λz (Terminal elimination rate constant)

  To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet.

  Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days)

• CL/F (Apparent clearance)

  To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet.

  Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days)

• Vd/F (Apparent volume of distribution during terminal phase)

  To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet.

  Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days)

Secondary Outcomes (1)

• Number of participants with treatment emergent adverse events (TEAE) and treatment emergent serious adverse events (TESAE)

  From Screening (Day - 28 to Day -1) to Follow-up visit ((7 ± 2 days after Final Dose)/EOS) (approximately 47 days)

Study Arms (6)

Treatment sequence ABC

EXPERIMENTAL

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Treatment sequence ACB

EXPERIMENTAL

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Treatment sequence BAC

EXPERIMENTAL

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Treatment sequence BCA

EXPERIMENTAL

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Treatment sequence CAB

EXPERIMENTAL

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Treatment sequence CBA

EXPERIMENTAL

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Interventions

Treatment A DRUG

Participants will receive single Dose A dose of ALXN2050 tablet (3 × Dose B) orally under fasted conditions.

Also known as: ACH-0145228

Treatment sequence ABC; Treatment sequence ACB; Treatment sequence BAC; Treatment sequence BCA; Treatment sequence CAB; Treatment sequence CBA

Treatment B DRUG

Participant will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally under fasted conditions.

Also known as: ACH-0145228

Treatment sequence ABC; Treatment sequence ACB; Treatment sequence BAC; Treatment sequence BCA; Treatment sequence CAB; Treatment sequence CBA

Treatment C DRUG

Participants will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally with a high-fat meal.

Also known as: ACH-0145228

Treatment sequence ABC; Treatment sequence ACB; Treatment sequence BAC; Treatment sequence BCA; Treatment sequence CAB; Treatment sequence CBA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Baltimore, Maryland, 21225, United States

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 13, 2022
• Study Start: October 13, 2022
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

US (1)