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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05780645
• Other study ID #: D7841C00008
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2023
• Est. completion date: February 26, 2024

Study information

• Verified date: June 2024
• Source: Alexion Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• ALXN2050 MR Prototype Tablet
Participants will receive various doses of the MR Prototype Tablet orally.
• ALXN2050 Immediate Release (IR) Tablet
Participants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally.
• ALXN2050 MR Prototype Mini-Tablet
Participants will receive various doses of the MR Prototype Mini-Tablet orally.

Locations

Country	Name	City	State
United Kingdom	Research Site	Ruddington

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of ALXN2050		Up to 96 hours postdose
Primary	Time to Reach Cmax (Tmax) of ALXN2050		Up to 96 hours postdose
Primary	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	Number of Participants With Adverse Events (AEs)		Day 1 up to Day 15