Phase 1
Completed N=25
Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir
Healthy
Source: ClinicalTrials.gov NCT01785160 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: AUC( Tau,ss) — 4070; 11100 ng*h/mL — p=0.9999
Summary
The primary objective of this trial is to investigate effect of faldaprevir on steady state pharmacokinetics of raltegravir.
The assessment of safety and tolerability will be an additional objective of this trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC( Tau,ss) |
4070; 11100 | 0.9999 |
| PRIMARY Cmax ,ss |
1300; 3220 | 0.9973 |
Eligibility Criteria
Inclusion criteria
- healthy male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01785160). 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.