Trial intelligence / Profile preview

Dexlansoprazole PK/PD and Safety in Infants with Acid-Related Diseases

NCT02442752Phase 1Withdrawn

Sponsor
Takeda
Start
Jun 2025
Primary completion
Dec 2025
Modality
Small Molecules
Countries
5
01

Overview

Phase 1, randomised, open-label trial of dexlansoprazole in gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) (4 arms), sponsored by Takeda. Primary endpoints: Maximum Observed Plasma Concentration, Area Under the Plasma Concentration-Time Curve from Time 0 to Last Quantifiable Concentration and 5 more. Planned start Jun 2025; status: withdrawn.

02

Drugs

dexlansoprazole
03

Conditions

gastroesophageal reflux disease (GERD)erosive esophagitis (EE)

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