Trial intelligence / Profile preview

Effect of Nintedanib on Microgynon PK in SSc-ILD

NCT03675581Phase 1Completed

Sponsor
Boehringer Ingelheim
Start
Nov 2018
Primary completion
Oct 2019
Modality
Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands
Countries
6
01

Overview

Phase 1, open-label, single-arm trial of nintedanib in systemic sclerosis-associated interstitial lung disease (SSc-ILD), sponsored by Boehringer Ingelheim. Primary endpoints: Area Under the Concentration-time Curve of Ethinylestradiol in Plasma from 0 to Last Quantifiable Data Point at 48 hours, Area Under the Concentration-time Curve of Levonorgestrel in Plasma from 0 to Last Quantifiable Data Point at 48 hours and 2 more. Started Nov 2018; status: completed.

02

Drugs

nintedanib
03

Conditions

systemic sclerosis-associated interstitial lung disease (SSc-ILD)

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