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

A Two-Part Phase 1 Study to Evaluate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: ALXN2050 MR Prototype Tablet; Drug: ALXN2050 Immediate Release (IR) Tablet; Drug: ALXN2050 MR Prototype Mini-Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Ruddington, Nottinghamshire, United Kingdom, NG11 6JS
      • Recruiting
      • Quotient Science Ltd
      • Principal Investigator: Sharanpreet Sidhu, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: ALXN2050 MR Prototype Tablet; Participants will receive various doses of the MR Prototype Tablet orally.; Drug: ALXN2050 Immediate Release (IR) Tablet; Participants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally.
Experimental: 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	Drug: ALXN2050 Immediate Release (IR) Tablet; Participants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally.; Drug: ALXN2050 MR Prototype Mini-Tablet; Participants will receive various doses of the MR Prototype Mini-Tablet orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events (AEs)	Day 1 up to Day 15

Collaborators and Investigators

• Sponsor: Alexion
• Investigators: Principal Investigator: Sharanpreet Sidhu, Dr, Quotient Science Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ALXN2050-HV-114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No