Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers

NCT03478436 | Completed Phase 1

• 1 other identifier: Version 1.0 / 04.05.2016
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rosacea

Keywords

pharmacokinetics; microdialysis; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• AUC0-t

  mg∙h/L

  at day 14

Study Arms (2)

fed group

OTHER

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

Drug: Doxycycline

fasting group

OTHER

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

Drug: Doxycycline

Interventions

Doxycycline DRUG

Doxycycline 40 mg capsules

fasting group; fed group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Investigator/Sub-Investigator
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Dr. Reddy's Laboratories Limited: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Rosacea

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Markus Zeitlinger

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv.-Doz. Dr.

Model Details: parallel groups to compare outcomes between fed and fasting conditions

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 27, 2018
• Study Start: July 1, 2016
• Primary Completion: October 25, 2016
• Study Completion: October 25, 2016
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)