Phase 1
Completed N=51
Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin
Healthy
Source: ClinicalTrials.gov NCT01795937 ↗
Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: AUCτ,ss (Itraconazole Part) — 29900; 59500 ng*h/mL
Summary
To investigate the effect of steady-state itraconazole on the pharmacokinetics of steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of rosuvastatin
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUCτ,ss (Itraconazole Part) |
29900; 59500 | — |
| PRIMARY Cmax,ss (Itraconazole Part) |
2780; 5030 | — |
| PRIMARY AUC0-∞ of Atorvastatin (Statins Part) |
13.7; 129.0 | — |
| PRIMARY Cmax of Atorvastatin (Statins Part) |
0.94; 31.10 | — |
| PRIMARY AUC0-∞ of Rosuvastatin (Statins Part) |
24.9; 365.0 | — |
| PRIMARY Cmax of Rosuvastatin |
2.73; 89.6 | — |
| SECONDARY AUCτ,ss of Faldaprevir (Statins Part) |
145000; 136000 | — |
| SECONDARY Cmax,ss of Faldaprevir (Statins Part) |
12900; 12200 | — |
| SECONDARY AUC0-tz of Atorvastatin |
9.5; 129.6 | — |
| SECONDARY AUC0-tz of Rosuvastatin |
21.5; 361.0 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01795937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.