Relative Bioavailability of Nintedanib Given Alone and in Combination With Ketoconazole at Steady State in Healthy Male Volunteers (an Open-label, Randomised, Two-way Cross-over Clinical Phase I Study)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Maximum Measured Concentration (Cmax)
Study Overview
Brief Summary
The objective of the current study is to investigate the relative bioavailability of a single dose of nintedanib low or high dose with and without coadministration of ketoconazole at steady state
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1 Nintedanib (Reference)
single dose, oral with 240 ml water
Intervention: Nintedanib (Drug)
2 Nintedanib + Ketoconazole (Test)
Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water
Intervention: Ketoconazole (Drug)
2 Nintedanib + Ketoconazole (Test)
Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water
Intervention: Nintedanib (Drug)
3 Nintedanib (Reference)
single dose, oral with 240 ml water
Intervention: Nintedanib (Drug)
4 Nintedanib + Ketoconazole (Test)
Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water
Intervention: Nintedanib (Drug)
4 Nintedanib + Ketoconazole (Test)
Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water
Intervention: Ketoconazole (Drug)
Outcomes
Primary Outcomes
Maximum Measured Concentration (Cmax)
Time Frame: 1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration
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
Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)
Time Frame: 1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration
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
Secondary Outcomes
- Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)(1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration)