Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478436
• Other study ID #: Version 1.0 / 04.05.2016
• Status: Completed
• Phase: Phase 1
• First received: March 8, 2018
• Last updated: March 20, 2018
• Start date: July 2016
• Est. completion date: October 25, 2016

Study information

• Verified date: March 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 25, 2016
• Est. primary completion date: October 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Doxycycline
Doxycycline 40 mg capsules

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t	mg·h/L	at day 14