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NCT03147378

Food Effect Study of ModraDoc006 in Combination With Ritonavir

Completed Phase 1 Last updated 19 October 2021
What this trial tests

Phase 1 trial testing ModraDoc006/r in Solid Tumor, Adult in 18 participants. Completed in 4 April 2018.

Timeline
10 May 2017
Primary endpoint
4 April 2018
4 April 2018

Quick facts

Lead sponsorModra Pharmaceuticals
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment18
Start date10 May 2017
Primary completion4 April 2018
Estimated completion4 April 2018
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Modra Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Solid Tumor, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
    Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
  2. Energy metabolism in health and diseases.
    Liu H, Wang S, Wang J, Guo X, et al · · 2025 · cited 178× · PMID 39966374 · DOI 10.1038/s41392-025-02141-x
  3. Effect of Food on the Pharmacokinetics of the Oral Docetaxel Tablet Formulation ModraDoc006 Combined with Ritonavir (ModraDoc006/r) in Patients with Advanced Solid Tumours.
    Vermunt MAC, de Weger VA, Janssen JM, Lopez-Yurda MI, et al · · 2021 · cited 2× · PMID 33464545 · DOI 10.1007/s40268-020-00336-x

Verify or expand the search:

Other trials of ModraDoc006/r

Trials testing the same drug.

Other recruiting trials for Solid Tumor, Adult

Currently open trials in the same condition.

Other Modra Pharmaceuticals trials

Trials by the same sponsor.

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