Bioavailability Study of 2 Oral Formulations of ALXN1840

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2021-04-26

Brief Summary

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The study will assess the relative bioavailability of 2 different formulations of ALXN1840 in healthy participants.

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Detailed Description

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This is a two-way crossover study consisting of 2 dosing periods assessing a test and reference formulation of ALXN1840. A dose-proportionality parallel group design extension period will be conducted following completion of the two-way crossover period of the study and will assess 5 different ascending doses of ALXN1840. There will be at least a 14-day washout following doses between Periods 1 and 2 and also at least a 14-day washout following the dose in Period 2 and the following dose in the Dose-Proportionality Extension Period.

Safety will be assessed throughout the study.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a 2-period, 2-sequence, crossover study with a parallel group extension.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crossover ALXN1840 Sequence 1

Participants will first receive a single dose of ALXN1840 test formulation on Day 1 of Period 1. After a washout period of 14 days, they will then receive a single dose of ALXN1840 reference formulation on Day 1 of Period 2.

Group Type EXPERIMENTAL