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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

NCT05780645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-06-06

No results posted yet for this study

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

Interventions

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.

DRUG

ALXN2050 MR Prototype Mini-Tablet

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

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2024-02-26
Completion
2024-02-26

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05780645 on ClinicalTrials.gov