RosaceaPhase 1NCT03478436
Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers
A Phase 1 study testing Doxycycline in people with Rosacea, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study explored the impact of food on skin and plasma pharmacokinetics of doxycycline Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2016to 25 Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Doxycycline
- Keywords
- pharmacokinetics, microdialysis, healthy volunteers
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline 40 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| fed group | Other | 14 once daily oral doses of doxycycline 40 mg, preceded by a standardized high-fat, high-calorie breakfast Receives: 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) Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
mg∙h/L
Measured: at day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study startJul 2016
- Primary completion25 Oct 2016
- Study completion25 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel groups to compare outcomes between fed and fasting conditions
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Reddy's Laboratories Limited
- Responsible party
- Principal investigator, Markus Zeitlinger, Medical University of Vienna
- Investigators
- Markus Zeitlinger, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478436
- Sponsor's protocol ID
- Version 1.0 / 04.05.2016
- Status last verified
- Mar 2018
- First submitted
- 8 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: publication in peer-reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of DFD-09 (Doxycycline) Capsules, 40 mg in Skin of Healthy Volunteers Under Fed and Fasting Conditions - an Exploratory Microdialysis Study
- ClinicalTrials.gov ID
- NCT03478436
- Acronym / sponsor ID
- Version 1.0 / 04.05.2016
- Conditions
- Rosacea
- Keywords
- pharmacokinetics, microdialysis, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Dr. Reddy's Laboratories Limited
- Study start
- Jul 2016 (actual)
- Primary completion
- 25 Oct 2016 (actual)
- Study completion
- 25 Oct 2016 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel groups to compare outcomes between fed and fasting conditions
| Arm | Type | Receives |
|---|---|---|
| fed group | Other | Drug: Doxycycline14 once daily oral doses of doxycycline 40 mg, preceded by a standardized high-fat, high-calorie breakfast |
| fasting group | Other | Drug: Doxycycline14 once daily oral doses of doxycycline 40 mg in fasting conditions (no food allowed 8 hours prior to dosing) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineDoxycycline 40 mg capsules | Drug | fasting group, fed group |
Primary outcome
AUC0-t
Time frame: at day 14
mg∙h/L
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Individual participant dataSharing planned: No. publication in peer-reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Zeitlinger principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doxycycline in people with Rosacea, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t (time frame: at day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.