NCT02983890

Dicloxacillin: Clinical Relevance of Drug-drug Interactions by Induction of Drug Metabolism.

Completed Phase 1 Last updated 23 August 2018

What this trial tests

Phase 1 trial testing Dicloxacillin in Healthy in 12 participants. Completed in 1 October 2017.

Timeline

6 October 2016

Primary endpoint
5 April 2017

1 October 2017

Quick facts

Lead sponsor	Per Damkier
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	6 October 2016
Primary completion	5 April 2017
Estimated completion	1 October 2017
Sites	1 location across Denmark

Drugs / interventions tested

• Dicloxacillin (DICLOXACILLIN) — full drug profile →
• Placebos — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Per Damkier

Who can join

Adults 18 to 55, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial is conducted as a cocktail-study namely an open-label, randomized, two-sequence, two-period crossover, cocktail study where a combination of cocktail-drugs is used to illustrate whether or not, or to what degree dicloxacillin affects the level of activity of the 5 most important CYP enzymes and therefore plays a potentially decisive role in serious drug-drug interactions.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dicloxacillin induces CYP2C19, CYP2C9 and CYP3A4 in vivo and in vitro.
   Stage TB, Graff M, Wong S, Rasmussen LL, et al · · 2018 · cited 26× · PMID 29105855 · DOI 10.1111/bcp.13467