Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT03478436
• Recruitment Status: Completed
• First Posted: March 27, 2018
• Last Update Posted: March 27, 2018
• Sponsor: Medical University of Vienna
• Collaborator: Dr. Reddy's Laboratories Limited
• Information provided by (Responsible Party): Markus Zeitlinger, Medical University of Vienna

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Rosacea	Drug: Doxycycline	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: parallel groups to compare outcomes between fed and fasting conditions
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Pharmacokinetics of DFD-09 (Doxycycline) Capsules, 40 mg in Skin of Healthy Volunteers Under Fed and Fasting Conditions - an Exploratory Microdialysis Study
• Actual Study Start Date: July 2016
• Actual Primary Completion Date: October 25, 2016
• Actual Study Completion Date: October 25, 2016

Arms and Interventions

Arm	Intervention/treatment
fed group; 14 once daily oral doses of doxycycline 40 mg, preceded by a standardized high-fat, high-calorie breakfast	Drug: Doxycycline; Doxycycline 40 mg capsules
fasting group; 14 once daily oral doses of doxycycline 40 mg in fasting conditions (no food allowed 8 hours prior to dosing)	Drug: Doxycycline; Doxycycline 40 mg capsules

Outcome Measures

Primary Outcome Measures :

1. AUC0-t [ Time Frame: at day 14 ]
   mg∙h/L

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Austria

Medical University of Vienna

Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Dr. Reddy's Laboratories Limited

Investigators

• Principal Investigator: Markus Zeitlinger; Department of Clinical Pharmacology, Medical University of Vienna

More Information

• Responsible Party: Markus Zeitlinger, Assoc. Prof. Priv.-Doz. Dr., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT03478436
• Other Study ID Numbers: Version 1.0 / 04.05.2016
• First Posted: March 27, 2018
• Last Update Posted: March 27, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: publication in peer-reviewed journal

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Markus Zeitlinger, Medical University of Vienna:

pharmacokinetics; microdialysis; healthy volunteers

Additional relevant MeSH terms:

Rosacea; Skin Diseases; Doxycycline; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents