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Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers

Primary Purpose

Rosacea

Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
Doxycycline
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rosacea focused on measuring pharmacokinetics, microdialysis, healthy volunteers

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

fed group

fasting group

Arm Description

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

14 once daily oral doses of doxycycline 40 mg in fasting conditions (no food allowed 8 hours prior to dosing)

Outcomes

Primary Outcome Measures

AUC0-t
mg∙h/L

Secondary Outcome Measures

Full Information

First Posted
March 8, 2018
Last Updated
March 20, 2018
Sponsor
Medical University of Vienna
Collaborators
Dr. Reddy's Laboratories Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03478436
Brief Title
Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers
Official Title
Pharmacokinetics of DFD-09 (Doxycycline) Capsules, 40 mg in Skin of Healthy Volunteers Under Fed and Fasting Conditions - an Exploratory Microdialysis Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
October 25, 2016 (Actual)
Study Completion Date
October 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
Dr. Reddy's Laboratories Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
pharmacokinetics, microdialysis, healthy volunteers

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
parallel groups to compare outcomes between fed and fasting conditions
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fed group
Arm Type
Other
Arm Description
14 once daily oral doses of doxycycline 40 mg, preceded by a standardized high-fat, high-calorie breakfast
Arm Title
fasting group
Arm Type
Other
Arm Description
14 once daily oral doses of doxycycline 40 mg in fasting conditions (no food allowed 8 hours prior to dosing)
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
Doxycycline 40 mg capsules
Primary Outcome Measure Information:
Title
AUC0-t
Description
mg∙h/L
Time Frame
at day 14

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Zeitlinger
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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

Learn more about this trial

Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers

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