NCT05319912

A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN1840 Enteric-coated Tablet	ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1.
DRUG	ALXN1840 Non-coated Capsule	ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.
DRUG	Omeprazole	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.

Timeline

• Start date: 2014-04-07
• Primary completion: 2014-05-29
• Completion: 2014-05-29
• First posted: 2022-04-08
• Last updated: 2023-08-02
• Results posted: 2023-08-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study