Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin

Study Overview
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Brief Summary
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To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters of nintedanib

Official Title
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Relative Bioavailability of a Single Oral Dose of Nintedanib Given Alone and in Combination With Multiple Oral Doses of Rifampicin in Healthy Male Volunteers (an Open-label, Two-period, Fixed Sequence Phase I Trial)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Nintedanib
* Drug: Rifampicin
* Drug: Nintedanib


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. Healthy male subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test<br>multiple doses of Rifampicin + single dose of Nintedanib | Drug: Rifampicin<br>* single dose once daily for 7 days<br>Drug: Nintedanib<br>* single dose administration<br>|
| Experimental: Reference<br>single dose of Nintedanib | Drug: Nintedanib<br>* single dose administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞) | AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity. For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib | 
| Maximum Measured Concentration (Cmax) | Cmax represents the maximum concentration of nintedanib in plasma. For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz) | AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from 0 to the last quantifiable analyte plasma concentration. For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib |