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

NCT05780645 | Completed Phase 1

• 1 other identifier: D7841C00008
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy participants

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of ALXN2050

  Up to 96 hours postdose

• Time to Reach Cmax (Tmax) of ALXN2050

  Up to 96 hours postdose

• Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of ALXN2050

  Up to 96 hours postdose

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Day 1 up to Day 15

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Drug: ALXN2050 MR Prototype Tablet; Drug: ALXN2050 Immediate Release (IR) Tablet

Cohort 2

EXPERIMENTAL

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

Drug: ALXN2050 Immediate Release (IR) Tablet; Drug: ALXN2050 MR Prototype Mini-Tablet

Interventions

ALXN2050 MR Prototype Tablet DRUG

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

Cohort 1

ALXN2050 Immediate Release (IR) Tablet DRUG

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

Cohort 1; Cohort 2

ALXN2050 MR Prototype Mini-Tablet DRUG

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

Cohort 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Research Site

Ruddington, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 22, 2023
• Study Start: March 15, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

GB (1)