CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 54 enrolled
Drug / intervention
ALXN1840 +1 moredrug
Likely dose
ALXN1840 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04526210
NCT04526210Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, 2-Period, 2-Sequence, Cross-over Study to Determine the Effect of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants

Alexion Pharmaceuticals, Inc.·interventional·Posted Aug 25, 2020·Updated Aug 31, 2023

In Brief

A Phase 1 clinical trial evaluating ALXN1840 and Bupropion Hydrochloride for Wilson Disease. Completed, enrolled 54 participants across 1 site.

Detailed Summary

This is a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of bupropion, a sensitive cytochrome P450 2B6 (CYP2B6) substrate, in healthy male and female participants. The safety and tolerability of ALXN1840 will be determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via total molybdenum with the coadministration of bupropion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWilson Disease
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedAug 25, 2020
Enrollment StartOct 21, 2020
Primary CompletionMay 28, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.9 years ago

Interventions

ALXN1840drug

ALXN1840 will be administered orally as a single dose as 4 x 15 mg enteric-coated tablets with 240 milliliters of water (fasting), for a total dose of 60 mg.

Bupropion Hydrochloridedrug

Bupropion hydrochloride will be administered orally as a single dose as one 150 milligrams (mg) tablet with 240 milliliters of water (fasting).