A Study to Investigate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants

NCT ID: NCT05780645

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2024-02-26

Brief Summary

The primary objectives of this study are to investigate the relative bioavailability and PK (Pharmacokinetic) profile of 2 ALXN2050 MR (Modified Release) formulations in comparison with the IR (Immediate Release) formulation.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Regimen A: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions.

Regimen B: Participants will receive Dose C ALXN2050 MR Prototype Tablet orally under fasted conditions.

Optional Regimens C, D, E, and F

Group Type: EXPERIMENTAL

ALXN2050 MR Prototype Tablet

Intervention Type: DRUG

Participants will receive various doses of the MR Prototype Tablet orally.

ALXN2050 Immediate Release (IR) Tablet

Intervention Type: DRUG

Participants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally.

Cohort 2

Regimen G: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions.

Regimen H: Participants will receive Dose C ALXN2050 MR Prototype Mini-Tablet orally under fasted conditions.

Optional Regimens: I, J, K, and L

Group Type: EXPERIMENTAL

ALXN2050 Immediate Release (IR) Tablet

Intervention Type: DRUG

Participants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally.

ALXN2050 MR Prototype Mini-Tablet

Intervention Type: DRUG

Participants will receive various doses of the MR Prototype Mini-Tablet orally.

Interventions

ALXN2050 MR Prototype Tablet

Participants will receive various doses of the MR Prototype Tablet orally.

Intervention Type: DRUG

ALXN2050 Immediate Release (IR) Tablet

Participants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally.

Intervention Type: DRUG

ALXN2050 MR Prototype Mini-Tablet

Participants will receive various doses of the MR Prototype Mini-Tablet orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males or non-pregnant, non-lactating healthy females.
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
• BMI within the range of 18.0 to 30.0 kg/m2 (inclusive), with a minimum body weight of 50.0 kg at screening.
• Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.

Exclusion Criteria

• History of clinically significant respiratory, cardiovascular, dermatological, hepatic, renal, GI, endocrinological, hematological, psychological, psychiatric, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
• History of meningococcal infection.
• History of clinically significant hypersensitivity reactions to commonly used antibacterial agents, including beta lactams, penicillin, aminopenicillins, fluoroquinolones (specifically including ciprofloxacin), 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 clinically significant hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
• History of significant multiple and/or severe allergies (eg, drug, latex allergy, band aids, adhesive dressing, or medical tape). Hay fever is allowed unless it is active.
• History of seizures including childhood seizures.
• History of significant head injury, or head trauma requiring medical evaluation.
• History of malignancy within 5 years of screening, with the exception of non-melanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
• Any previous procedure, including history of stomach or intestinal surgery or resection, cholecystectomy, gallstones, TIPS, or surgical shunt, that could alter absorption or excretion of orally administered drugs.
• Significant current or chronic history of liver disease.
• Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Ruddington, , United Kingdom

Countries

United Kingdom

Other Identifiers

D7841C00008

Identifier Type: -

Identifier Source: org_study_id