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

NCT02983890 | Completed Phase 1 DMC

• 1 other identifier: AKF-388
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• AUC(area under the curve) for tolbutamid (CYP2C9), as a result of dicloxacillin-treatment

  AUC measurements giving an estimate of activity og the relevant enzymes.

  Pharmacological outcome measures at t=0 predose and postdose; 0.5,1,2,3,4,6,8,10,12,24.

Secondary Outcomes (4)

• *AUC(area under the curve) for midazolam (CYP3A4) and dextromethorphan (CYP1A2) omeprazole (CYP2C19) and caffein (CYP1A2)

  Pharmacological outcome measures at t=0 predose and postdose; 0.5,1,2,3,4,6,8,10,12,24.

• T(max)

  Pharmacological outcome measures at t=0 predose and postdose; 0.5,1,2,3,4,6,8,10,12,24.

• C(max) (peak plasma concentration)

  Pharmacological outcome measures at t=0 predose and postdose; 0.5,1,2,3,4,6,8,10,12,24.

• Clearance

  Pharmacological outcome measures at t=0 predose and postdose; 0.5,1,2,3,4,6,8,10,12,24.

Study Arms (2)

Arm of study1

ACTIVE COMPARATOR

Dicloxacillin tablets.

Drug: Dicloxacillin

Arm of study 2

PLACEBO COMPARATOR

No treatment

Drug: Placebos

Interventions

Dicloxacillin DRUG

Tablets containing dicloxacillin are taken 500mg 2x 3 times per day, for 10 days. Followed by test-day nr 1 at day 11. Both arms receives both treatments, randomly assigned

Also known as: antibiotics

Arm of study1

Placebos DRUG

No drug are taken for 10 days. Non-blinded. Followed by test-day nr 1 at day 11. Both arms receives both treatments, randomly assigned

Arm of study 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are you in a general healthy condition?; questions asked; Are you healthy in general? 2; Do you have any chronic diseases? 3; Are you taking any medications regularly? 4, Are you taking any medications periodically . 5; Are you taking nutrition supplements, "nature-medicine" or over-the-counter drugs
• BMI; range; 18,5-29,9 kg/m2
• eGFR(estimated glomerular filtration rate), ALAT(alanine aminotransferase), bilirubin, hæmoglobin og HbA1c, should be within normal limits or without clinically significantly deviation from these.
• Non-Smoker

You may not qualify if:

• Hypersensitivity to applied medications. Known allergy to penicillin or type 1-reaction to cefalosporins.
• Known allergy to sulfonamides
• Clinically relevant intake of receipt-required medication, over-the-counter medication or nutritional supplements.
• Chronic or daily intake of alcohol.
• Participation in other Intervention-studies

Sponsors & Collaborators

• Per Damkier: lead

Study Sites (1)

Klinisk Biokemisk Farmakologi syddansk universitet

Odense, Funen, 5000, Denmark

Location

MeSH Terms

Interventions

Dicloxacillin; Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Cloxacillin; Oxacillin; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Per Damkier, Ph.d.

  Assosiated to department of biochemistry and pharmacology at University of southern denmark, Odense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, head consultant, MD, ph.d.

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 6, 2016
• Study Start: October 6, 2016
• Primary Completion: April 5, 2017
• Study Completion: October 1, 2017
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)