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

Primary Purpose

Healthy Participants

Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
ALXN2050 MR Prototype Tablet
ALXN2050 Immediate Release (IR) Tablet
ALXN2050 MR Prototype Mini-Tablet
Sponsored by
Alexion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Participants

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Quotient Science LtdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of ALXN2050
Time to Reach Cmax (Tmax) of ALXN2050
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of ALXN2050

Secondary Outcome Measures

Number of Participants With Adverse Events (AEs)

Full Information

First Posted
March 13, 2023
Last Updated
April 26, 2023
Sponsor
Alexion
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1. Study Identification

Unique Protocol Identification Number
NCT05780645
Brief Title
A Study to Investigate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
ALXN2050 MR Prototype Tablet
Intervention Description
Participants will receive various doses of the MR Prototype Tablet orally.
Intervention Type
Drug
Intervention Name(s)
ALXN2050 Immediate Release (IR) Tablet
Intervention Description
Participants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally.
Intervention Type
Drug
Intervention Name(s)
ALXN2050 MR Prototype Mini-Tablet
Intervention Description
Participants will receive various doses of the MR Prototype Mini-Tablet orally.
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of ALXN2050
Time Frame
Up to 96 hours postdose
Title
Time to Reach Cmax (Tmax) of ALXN2050
Time Frame
Up to 96 hours postdose
Title
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of ALXN2050
Time Frame
Up to 96 hours postdose
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Time Frame
Day 1 up to Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexion Pharmaceuticals, Inc.
Phone
1-855-752-2356
Email
clinicaltrials@alexion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharanpreet Sidhu, Dr
Organizational Affiliation
Quotient Science Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Science Ltd
City
Ruddington
State/Province
Nottinghamshire
ZIP/Postal Code
NG11 6JS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharanpreet Sidhu, Dr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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