At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
Ofev® +2 moredrug
Likely dose
Not stated in 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.
A Phase I Study for Formulation Selection and Subsequent Optimization of Two Different Oral Formulations of Nintedanib in Healthy Male Subjects (Open-label, Randomised, Single-dose Study in Three Parts)
In Brief
A Phase 1 clinical trial evaluating Ofev®, Nintedanib formulation 1, and 1 other intervention for Healthy. Completed, enrolled 21 participants across 1 site.
Detailed Summary
The main objective of this trial is to assess single dose drug exposure of several newly developed formulation prototypes of Nintedanib compared to Ofev® following oral administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedMar 2022
Enrollment StartMar 2022
Primary CompletionNov 2022
TodayJul 2026
First PostedMar 2, 2022
Enrollment StartMar 28, 2022
Primary CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.3 years ago
Interventions
Ofev®drug
Ofev®
Nintedanib formulation 1drug
Nintedanib formulation 1: Monolithic Nintedanib Modified Release Tablet (MR1) as two Prototypes (MR1-1 and MR1-2).
Nintedanib formulation 2drug
Nintedanib formulation 2: Polyox Nintedanib Modified Release Tablet (MR2) as two Prototypes (MR2-1 and MR2-2).