drugset / Trial / NCT05242926
Absorption and Excretion of Oral Docetaxel
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 20 mg | Oral |
| Subject | Docetaxel | Small molecule | 30 mg | Oral |
| Background | Ritonavir | Other / unclassified | 100 mg | Oral |