NCT03147378

Food Effect Study of ModraDoc006 in Combination With Ritonavir

Food-effect Study of Weekly Administration of (bi-)Daily Oral Docetaxel (ModraDoc006) in Combination With Ritonavir

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Modra Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effect of food on the pharmacokinetics of ModraDoc006 in combination with ritonavir, in an open-label, cross-over design. Patients will be randomized into two treatment groups receiving ModraDoc006/r week 1 under fasting and week 2 under fed condition, or vice versa.

Detailed description

In this study the effect of food on the plasma exposure of ModraDoc006/ritonavir will be assessed in an open-label, cross-over design. Patients will receive ModraDoc006/ritonavir at the dose of 30 mg ModraDoc006 with 100 mg ritonavir. Patients will be randomized 1:1 into two treatment groups (in total 16 evaluable patients are needed): * Group A: will receive ModraDoc006/ritonavir under fasting conditions the first week and in a fed condition the second week of treatment. * Group B: will receive ModraDoc006/ritonavir under fed condition the first week and under fasted condition the second week of treatment. The department of pharmacy of The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital has developed a solid oral dosage form of docetaxel, ModraDoc006 10 mg tablets. This formulation has been investigated in two phase I clinical studies in combination with the CYP3A4 inhibitor ritonavir, according to a weekly once-daily (QD) or bi-daily (BID) schedule, respectively. Maximum Tolerated Dose (MTD) and pharmacokinetics of both regimes have been determined and further clinical testing is being planned, in particular of the weekly bi-daily regime. The aim of the current study is to evaluate the effect of food on the pharmacokinetics of ModraDoc006 in combination with ritonavir. For the ritonavir tablet formulation used in this trial a food-effect on the bio-availability has been found in two prior studies. In these trials the plasma concentrations were lower when ritonavir was given after a moderate or high-fat meal. Plasma concentrations and T-lag were dependent on the type/amount of food administered. Concentrations were lower and T-lag longer when a high-fat meal was administered as compared to a moderate fat meal. Randomization will be performed centrally at the Biometrics Department of the Netherlands Cancer Institute using a minimization technique as implemented in TENALEA©. Pharmacokinetics will be performed in week 1 and 2 for up to 48 hours after study drug administration (see Pharmacokinetics paragraph for exact time points). Patients will receive a high-fat meal on the morning of the day of fed condition pharmacokinetics, half an hour prior to intake of ModraDoc006/ritonavir. After week 2, the N15FED study will be completed and patients can be enrolled in the roll over study N17DEX to continue their treatment with ModraDoc006/r (at the dose of BID 30/20 mg ModraDoc006 in combination with BID 100 mg ritonavir) in their best interest and to assess the long-term safety of this treatment.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	ModraDoc006/r	Treatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets in fed or fasting condition

Timeline

• Start date: 2017-05-10
• Primary completion: 2018-04-04
• Completion: 2018-04-04
• First posted: 2017-05-10
• Last updated: 2021-10-19

Locations

1 site across 1 country: Netherlands