Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir

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.

Timeline

Start

2013-02

Primary completion

2013-03

Completion

2013-03

Outcome

Missed primary endpoint

registry analysis (non-inferiority or equivalence test); Raltegravir vs Raltegravir + Faldaprevir; p = 0.9999; Adjusted Geometric Mean ratio 272.06 (95% CI 199.69 to 370.66) NCT01785160 ↗

registry analysis (non-inferiority or equivalence test); Raltegravir vs Raltegravir + Faldaprevir; p = 0.9973; Adjusted Geometric Mean ratio 245.72 (95% CI 168.460 to 358.404) NCT01785160 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Faldaprevir	Small molecule	—	Oral
Subject	Raltegravir	Other / unclassified	—	Oral

Indications

No indication recorded.