Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Doxycycline

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Markus Zeitlinger, Department of Clinical Pharmacology, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): October 25, 2016
• Study Completion (Actual): October 25, 2016

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: pharmacokinetics; healthy volunteers; microdialysis
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: Version 1.0 / 04.05.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: publication in peer-reviewed journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No