NCT05319899

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

A Phase 1, Single-Center, Randomized, 3-Period Crossover Study to Evaluate the Relative Bioavailability of WTX101 in Healthy Subjects After Single Dose Administration of a Non-Coated Formulation With and Without a Proton Pump Inhibitor and With a Proton Pump Inhibitor With and 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 Molybdenum.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN1840	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: 2014-01-20
• Primary completion: 2014-03-24
• Completion: 2014-03-24
• First posted: 2022-04-08
• Last updated: 2023-08-01
• Results posted: 2023-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study