Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers

NCT ID: NCT03478436

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-10-25

Brief Summary

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

Conditions

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

fed group

14 once daily oral doses of doxycycline 40 mg, preceded by a standardized high-fat, high-calorie breakfast

Group Type: OTHER

Doxycycline

Intervention Type: DRUG

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)

Group Type: OTHER

Doxycycline

Intervention Type: DRUG

Doxycycline 40 mg capsules

Interventions

Doxycycline

Doxycycline 40 mg capsules

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Markus Zeitlinger

Assoc. Prof. Priv.-Doz. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markus Zeitlinger

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

Version 1.0 / 04.05.2016

Identifier Type: -

Identifier Source: org_study_id