Phase 1
Completed N=15
Investigation of Food Effect and Gastric ph Increase on the Bioavailability of Faldapravir
Healthy
Source: ClinicalTrials.gov NCT01694706 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) — 37900; 48200; 36000 [ng*h/mL] — p=0.3420
Summary
The primary objective of this trial is to investigate the effect of food and of gastric pH increase on the relative bioavailability of faldaprevir.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) |
37900; 48200; 36000 | 0.3420 |
| PRIMARY Faldaprevir: Maximum Measured Concentration (Cmax) |
2030; 2600; 1920 | 0.3993 |
| SECONDARY Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) |
36300; 46400; 34400 | 0.3765 |
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
Exclusion criteria
- Any relevant deviation from healthy condition
Data sourced from ClinicalTrials.gov (NCT01694706). 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.