CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
ALXN1840 +1 moredrug
Likely dose
ALXN1840 15 milligramfrom 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/NCT04526197
NCT04526197Phase 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 CYP2C9 Substrate in Healthy Participants.

Alexion Pharmaceuticals, Inc.·interventional·Posted Aug 25, 2020·Updated Aug 21, 2023

In Brief

A Phase 1 clinical trial evaluating ALXN1840 and Celecoxib for Wilson Disease. Completed, enrolled 36 participants across 1 site.

Detailed Summary

This was a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of celecoxib, a sensitive cytochrome P450 2C9 (CYP2C9) substrate, in healthy male and female participants. The safety and tolerability of ALXN1840 were determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via total molybdenum with the coadministration of celecoxib.

Study Details

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

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedAug 25, 2020
Enrollment StartJul 7, 2020
Primary CompletionNov 3, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.9 years ago

Interventions

ALXN1840drug

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

Celecoxibdrug

Celecoxib was administered orally as a single dose as one 200-mg tablet with 240 mL of water (fasting).