drugset / Trial / NCT05242926

Absorption and Excretion of Oral Docetaxel

NCT05242926

Phase 1 Withdrawn Modra Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, phase I study to investigate the influence of the bi-daily weekly dosing of ModraDoc006/ritonavir on the absorption and excretion of docetaxel in patients with advanced solid tumours. The pharmacokinetics, absorption and excretion of docetaxel will be investigated during the study. Patients will receive 30 mg in the morning / 20 mg in the afternoon ModraDoc006 with BID 100 mg ritonavir in a fasted condition (i.e. at least 1 hour before or 2 hours after any food assumption), followed by collection of plasma, faeces and urine samples.

Timeline

Start
2017-10
Primary completion
2018-04
Completion
2018-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 20 mg Oral
Subject Docetaxel Small molecule 30 mg Oral
Background Ritonavir Other / unclassified 100 mg Oral

Indications