Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers

Study Overview
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Brief Summary
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This study explored the impact of food on skin and plasma pharmacokinetics of doxycycline

Detailed Description
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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.

Official Title
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Pharmacokinetics of DFD-09 (Doxycycline) Capsules, 40 mg in Skin of Healthy Volunteers Under Fed and Fasting Conditions - an Exploratory Microdialysis Study

Conditions
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Rosacea

Intervention / Treatment
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* Drug: Doxycycline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel groups to compare outcomes between fed and fasting conditions
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: fed group<br>14 once daily oral doses of doxycycline 40 mg, preceded by a standardized high-fat, high-calorie breakfast | Drug: Doxycycline<br>* Doxycycline 40 mg capsules<br>|
| Other: fasting group<br>14 once daily oral doses of doxycycline 40 mg in fasting conditions (no food allowed 8 hours prior to dosing) | Drug: Doxycycline<br>* Doxycycline 40 mg capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t | mg∙h/L | at day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, microdialysis, healthy volunteers