Bioequivalence Between 180 mg and 60 mg ALXN2050 Tablets and Food Effect on ALXN2050 Pharmacokinetics

Healthy Adult Participants Clinical Trial

Official title:
A Phase 1 Study to Assess the Bioequivalence Between 180 mg and 60 mg ALXN2050 Tablets and the Effect of Food on ALXN2050 Pharmacokinetics in Healthy Adult Participants

Status Completed

Clinical Trial Summary

This study will assess the Bioequivalence between 180 mg and 60 mg ALXN2050 Tablets and the Effect of Food on ALXN2050 Pharmacokinetics.

Clinical Trial Description

This is a single-center, open-label, randomized, 3-period crossover study. Screening of participants will occur within 28 days prior to the first dose of study intervention. The study will comprise of 3 Treatment Periods: Treatment period 1, Treatment period 2, Treatment period 3. There will be a washout period of at least 4 days between the ALXN2050 dose in each treatment period. Participants will be enrolled and will be randomized 1:1:1:1:1:1 to receive one of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA). On the morning of Day 1 of each of the 3 periods, participants will receive one of the following treatments as per the randomization scheme. - Treatment A: Dose B of ALXN2050 tablet under fasted conditions - Treatment B: A single Dose A dose of ALXN2050 tablet under fasted conditions - Treatment C: A single Dose A dose of ALXN2050 tablet with a high-fat meal Duration of study conduct (screening to follow-up): approximately 47 days. ;

Study Design

Related Conditions & MeSH terms

Healthy Adult Participants

Clinical Trial Details

NCT number	NCT05578846
Study type	Interventional
Source	Alexion Pharmaceuticals
Contact
Status	Completed
Phase	Phase 1
Start date	October 13, 2022
Completion date	January 5, 2023

View Details

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