Adults 18 to 55, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area Under the Concentration-time Curve of 3 Different Formulations of Nintedanib (MR1, MR2 and Ofev®) in Plasma Over the Time Interval From 0 Extrapolated to Infinity Which Includes Also the Second Nintedanib (Ofev®) Dose of the Day (AUC₀-∞)Primary· Within 3 hours (h) prior and 1, 2, 3, 4, 6, 8, 10, 12, 13 (except MR1, MR2), 14, 15, 16, 17 (except R), 18, 20, 22, 24, 34, 48, 58, and 72 h after administration.
The area under the concentration-time curve over the time interval from 0 \[first dose\] extrapolated to infinity (AUC₀-∞) was analyzed in 3 different formulations of Nintedanib (MR1, MR2 and Ofev®) and in two cohorts:
* Cohort 1: Nintedanib formulation 1: Monolithic Nintedanib Modified Release Tablet (MR1) as two Prototypes (MR1-1 and MR1-2),
* Cohort 2: Nintedanib formulation 2: Polyox Nintedanib Modified Release Tablet (MR2) as two Prototypes (MR2-1 and MR2-2), and each compared to the reference (R) treatment: Nintedanib formulation 3: Ofev® capsules.
The adjusted geometric least squares
Group
Value
95% CI
Cohort 1: Reference (R)
359.80
± NA
Cohort 1: Test Treatment 1 (MR1-1)
60.04
± NA
Cohort 1: Test Treatment 2 (MR1-2)
48.72
± NA
Cohort 2: Reference (R)
241.32
± NA
Cohort 2: Test Treatment 1 (MR2-1)
100.88
± NA
Cohort 2: Test Treatment 2 (MR2-2)
103.55
± NA
Area Under the Concentration-time Curve of 3 Different Formulations of Nintedanib (MR1, MR2 and Ofev®) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC₀-tz)Secondary· Within 3 hours (h) prior and 1, 2, 3, 4, 6, 8, 10, 12, 13 (except MR1, MR2), 14, 15, 16, 17 (except R), 18, 20, 22, 24, 34, 48, 58, and 72 h after administration.
The area under the concentration-time curve over the time interval from 0 to the last quantifiable data point (AUC₀-tz) was analyzed in 3 different formulations of Nintedanib (MR1, MR2 and Ofev®) and in two cohorts:
* Cohort 1: Nintedanib formulation 1: Monolithic Nintedanib Modified Release Tablet (MR1) as two Prototypes (MR1-1 and MR1-2),
* Cohort 2: Nintedanib formulation 2: Polyox Nintedanib Modified Release Tablet (MR2) as two Prototypes (MR2-1 and MR2-2), and each compared to the reference (R) treatment: Nintedanib formulation 3: Ofev® capsules.
The adjusted geometric least squares mea
Group
Value
95% CI
Cohort 1: Reference (R)
326.48
± NA
Cohort 1: Test Treatment 1 (MR1-1)
30.54
± NA
Cohort 1: Test Treatment 2 (MR1-2)
40.51
± NA
Cohort 2: Reference (R)
226.69
± NA
Cohort 2: Test Treatment 1 (MR2-1)
85.91
± NA
Cohort 2: Test Treatment 2 (MR2-2)
81.35
± NA
Maximum Measured Concentration of 3 Different Formulations of Nintedanib (MR1, MR2 and Ofev®) in Plasma Within the 24h Dosing Interval (Cmax)Secondary· Within 3 hours (h) prior and 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 13.0 (except MR1, MR2), 14.0, 15.0, 16.0, 17.0 (except R), 18.0, 20.0, 22.0, 24.0, 34.0, 48.0, 58.0, and 72 h after administration
The maximum measured concentration in plasma was analyzed in 3 different formulations of Nintedanib (MR1, MR2 and Ofev®) and in two cohorts:
* Cohort 1: Nintedanib formulation 1: Monolithic Nintedanib Modified Release Tablet (MR1) as two Prototypes (MR1-1 and MR1-2),
* Cohort 2: Nintedanib formulation 2: Polyox Nintedanib Modified Release Tablet (MR2) as two Prototypes (MR2-1 and MR2-2), and each compared to the reference (R) treatment: Nintedanib formulation 3: Ofev® capsules.
The adjusted geometric least squares mean and adjusted geometric standard error were calculated by an analysis of v
Group
Value
95% CI
Cohort 1: Reference (R)
32.02
± NA
Cohort 1: Test Treatment 1 (MR1-1)
3.87
± NA
Cohort 1: Test Treatment 2 (MR1-2)
7.66
± NA
Cohort 2: Reference (R)
17.55
± NA
Cohort 2: Test Treatment 1 (MR2-1)
12.03
± NA
Cohort 2: Test Treatment 2 (MR2-2)
11.73
± NA
Concentration of 3 Different Formulations of Nintedanib (MR1, MR2 and Ofev®) in Plasma 24 Hours After the First Dose (C₂₄)Secondary· Within 3 hours (h) prior and 1, 2, 3, 4, 6, 8, 10, 12, 13 (except MR1, MR2), 14, 15, 16, 17 (except R), 18, 20, 22, 24, 34, 48, 58, and 72 h after administration.
The measured concentration in plasma 24 hours after first administration was analyzed in 3 different formulations of Nintedanib (MR1, MR2 and Ofev®) and in two cohorts:
* Cohort 1: Nintedanib formulation 1: Monolithic Nintedanib Modified Release Tablet (MR1) as two Prototypes (MR1-1 and MR1-2),
* Cohort 2: Nintedanib formulation 2: Polyox Nintedanib Modified Release Tablet (MR2) as two Prototypes (MR2-1 and MR2-2), and each compared to the reference (R) treatment: Nintedanib formulation 3: Ofev® capsules.
The adjusted geometric least squares mean and adjusted geometric standard error were ca
Group
Value
95% CI
Cohort 1: Reference (R)
5.48
± NA
Cohort 1: Test Treatment 1 (MR1-1)
0.66
± NA
Cohort 1: Test Treatment 2 (MR1-2)
0.77
± NA
Cohort 2: Reference (R)
4.10
± NA
Cohort 2: Test Treatment 1 (MR2-1)
1.32
± NA
Cohort 2: Test Treatment 2 (MR2-2)
1.29
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: From first drug administration in this period to at least 14 days thereafter OR until next drug administration of the following period, whatever occurred first, up to 22 days after last drug administration..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 29 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05262751.