Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers

Medical University of Vienna

Status and phase

Completed

Phase 1

Conditions

Rosacea

Treatments

Drug: Doxycycline

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03478436

Version 1.0 / 04.05.2016

Details and patient eligibility

About

This study explored the impact of food on skin and plasma pharmacokinetics of doxycycline

Full description

Sub-antimicrobial dose doxycycline is approved for the treatment of rosacea. This work investigated the pharmacokinetics of doxycycline in skin and plasma of fed and fasting healthy volunteers receiving a 14-day treatment course with once daily 40 mg doxycycline. Dermal measurements were performed by means of in vivo microdialysis.

Enrollment

6 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males

Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Investigator/Sub-Investigator
Signed written informed consent prior to inclusion in the study
18-45 years old inclusive
BMI: 18.5 to 30 kg/m2
SBP: 100-139 mmHg
DBP: 55-89 mmHg
PR: 55-100 bpm (measured after 5 min of rest, sitting position)
ability to comprehend the full nature and purpose of the study, including possible risks and side effects
ability to co-operate with the Investigator and to comply with the requirements of the entire study
availability to volunteer for the entire study duration and willing to adhere to all protocol requirements

Exclusion criteria

Any clinically relevant abnormalities in ECG (12 leads)

Any clinically relevant abnormal physical findings
Any clinically relevant abnormal laboratory values indicative of physical illness
Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drug or to tetracyclines in general
History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study
Any psychiatric illnesses
Presence of any skin condition that would interfere with the placement of microdialysis probes
Any dermatological drug therapy on the surface of both thighs within 14 days before study day 1 of this study
Use of any medication(including OTC) within 1 week prior to study day 1
Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort) within 1 month prior to study day 1
Participation in another clinical study investigating another IMP within 1 month prior to study day 1
Blood donations within 1 month prior to study day 1 or planned within 1 month after the last study-related blood draw
History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2005)
other objections to study participation in the opinion of the Investigator