CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
ALXN1840 Enteric-coated Tablet +2 moredrug
Likely dose
ALXN1840 Enteric-coated Tablet 60 milligramsfrom 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/NCT05319912
NCT05319912Phase 1Completed

A Phase 1, Single-Center, Randomized, 3-Period Crossover Study in Healthy Volunteers to Evaluate the Absorption of WTX101 After Single Dose Administration of an Enteric Coated Formulation With and Without Food and a Non-Coated Formulation Coadministered With a Proton Pump Inhibitor Without Food

Alexion Pharmaceuticals, Inc.·interventional·Posted Apr 8, 2022·Updated Aug 2, 2023

In Brief

A Phase 1 clinical trial evaluating ALXN1840 Enteric-coated Tablet, ALXN1840 Non-coated Capsule, and 1 other intervention for Healthy. Completed, enrolled 18 participants across 1 site.

Detailed Summary

This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Mo concentration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 8, 2022
Enrollment StartApr 7, 2014
Primary CompletionMay 29, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.2 years ago

Interventions

ALXN1840 Enteric-coated Tabletdrug

ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1.

ALXN1840 Non-coated Capsuledrug

ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.

Omeprazoledrug

Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1.