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Food Effect Study of ModraDoc006 in Combination With Ritonavir

NCT03147378 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-10-19

No results posted yet for this study

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.

Conditions

  • Solid Tumor, Adult

Interventions

DRUG

ModraDoc006/r

Treatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets in fed or fasting condition

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Modra Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Serena Marchetti, MD, PhD · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2018-04-04
Completion
2018-04-04

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03147378 on ClinicalTrials.gov