PsoriasisPhase 1NCT02936492
BAY1003803 Single and Multiple Dose Escalation, Safety, Tolerability and Pharmacokinetics Study
A Phase 1 study testing BAY1003803 0.01% lipophilic cream, BAY1003803 0.1% lipophilic cream and BAY1003803 0.01% ointment in people with Psoriasis, run by Bayer at 1 site in Germany.
Trial summary
Systemic safety following single and multiple dermal administration of BAY1003803 Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- BAY1003803 0.01% lipophilic cream, BAY1003803 0.1% lipophilic cream and BAY1003803 0.01% ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 24 Oct 2016to 16 Oct 2017
- 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject
- Age: 18 to 64 years (inclusive) at the first screening visit
- Body mass index (BMI): above or equal 18 and below or equal 30 kg / m² at the first screening visit
- Non-smoker at least 3 months prior to study start and during the study
- Healthy skin on which reddening can be easily recognized
Who cannot join
- A history of relevant diseases, especially incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, excretion and effect of the study drugs will not be normal, dermal diseases, diseases which present a risk for subjects to be treated with glucocorticoid receptor agonists (e.g. gastric ulcers, cornea ulcer, colitis ulcerosa, severe infections, glaucoma, diabetes, myocardial infarction, thromboembolic disease, hypertension, thyroid disease, tuberculosis, myasthenia gravis, osteoporosis, psychiatric diseases)
- Infections and febrile illness within 4 week before the first study drug administration
- Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them
- Inoculations with live vaccine within 8 weeks before the first study drug administration
- Signs of irritation or folliculitis or any other dermatological conditions in the test areas that would interfere with the planned assessments as judged by the Investigators
- Human leukocyte antigen-DR (HLA-DR) < 15000 AB/monocyte
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Escalating Dose Study for Safety, Tolerability and Pharmacokinetics After Single and Multiple Dermal Administration of Two BAY1003803 Formulation Types With Two Concentrations Each in Healthy Male Volunteers, Applying a Double-blind, Vehicle-controlled Design and Including a Positive Control Group
Systemic safety following single and multiple dermal administration of BAY1003803
- Conditions
- Psoriasis
- Being tested
- BAY1003803 0.01% lipophilic cream, BAY1003803 0.1% lipophilic cream, BAY1003803 0.01% ointment, BAY1003803 0.1% ointment, Lipophilic cream vehicle
- Keywords
- Phase I, Healthy volunteers
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1003803 0.01% lipophilic creamDrug
Topical administration for 22 h per day
BAY1003803 0.1% lipophilic creamDrug
Topical administration for 22 h per day
BAY1003803 0.01% ointmentDrug
Topical administration for 22 h per day
BAY1003803 0.1% ointmentDrug
Topical administration for 22 h per day
Lipophilic cream vehicleDrug
Topical administration for 22 h per day
Ointment vehicleDrug
Topical administration for 22 h per day
Clobetasol propionateDrug
Topical administration for 22 h per day
| Study group | Role | What they receive |
|---|---|---|
| BAY1003803 | Experimental | Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject Receives: Drug: BAY1003803 0.01% lipophilic cream; Drug: BAY1003803 0.1% lipophilic cream; Drug: BAY1003803 0.01% ointment; Drug: BAY1003803 0.1% ointment |
| Placebo | Placebo comparator | Topical treatment using matching amount of placebo Receives: Drug: Lipophilic cream vehicle; Drug: Ointment vehicle |
| Clobetasol propionate | Active comparator | Topical treatment using 16.5 mg of clobetasol propionate per subject Receives: Drug: Clobetasol propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol serum levels for safety
Measured: Up to 2 weeks
Frequency of treatment-emergent adverse events (TEAEs)
Measured: Up to 2 weeks
Nature of treatment-emergent adverse events (TEAEs)
Measured: Up to 2 weeks
Secondary outcomes (7)
Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 1, single dose)
Measured: Day 1 to 3 at 8:00 am
Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 2, multiple dose)
Measured: Day 1 to 8 at 8:00 am
Maximum plasma concentration (Cmax) after single dose of BAY1003803
Measured: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24 hours
Area under the plasma concentration vs. time curve from zero to infinity (AUC) after single dose of BAY1003803
Measured: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24, 27, 31, 35, 39, 47 hours
Area under the curve from time zero to 22 hours [AUC(0-22)] after single dose of BAY1003803
Measured: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22 hours
Maximum plasma concentration (Cmax,md) after multiple dose of BAY1003803
Measured: At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6)
Area under the curve from time zero to 24 hours [AUC(0-24)md] after multiple dose of BAY1003803
Measured: At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start24 Oct 2016
- Primary completion18 Apr 2017
- Study completion16 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936492
- Sponsor's protocol ID
- 17014
- Status last verified
- Nov 2017
- First submitted
- 17 Oct 2016
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escalating Dose Study for Safety, Tolerability and Pharmacokinetics After Single and Multiple Dermal Administration of Two BAY1003803 Formulation Types With Two Concentrations Each in Healthy Male Volunteers, Applying a Double-blind, Vehicle-controlled Design and Including a Positive Control Group
- ClinicalTrials.gov ID
- NCT02936492
- Acronym / sponsor ID
- 17014
- Conditions
- Psoriasis
- Keywords
- Phase I, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- 18 Apr 2017 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 18 Oct 2016 (estimated)
- 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.
Systemic safety following single and multiple dermal administration of BAY1003803
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BAY1003803 | Experimental | Drug: BAY1003803 0.01% lipophilic cream, Drug: BAY1003803 0.1% lipophilic cream, Drug: BAY1003803 0.01% ointment, Drug: BAY1003803 0.1% ointmentTopical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject |
| Placebo | Placebo comparator | Drug: Lipophilic cream vehicle, Drug: Ointment vehicleTopical treatment using matching amount of placebo |
| Clobetasol propionate | Active comparator | Drug: Clobetasol propionateTopical treatment using 16.5 mg of clobetasol propionate per subject |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subject
- Age: 18 to 64 years (inclusive) at the first screening visit
- Body mass index (BMI): above or equal 18 and below or equal 30 kg / m² at the first screening visit
- Non-smoker at least 3 months prior to study start and during the study
- Healthy skin on which reddening can be easily recognized
Key exclusion criteria (6 listed)
- A history of relevant diseases, especially incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, excretion and effect of the study drugs will not be normal, dermal diseases, diseases which present a risk for subjects to be treated with glucocorticoid receptor agonists (e.g. gastric ulcers, cornea ulcer, colitis ulcerosa, severe infections, glaucoma, diabetes, myocardial infarction, thromboembolic disease, hypertension, thyroid disease, tuberculosis, myasthenia gravis, osteoporosis, psychiatric diseases)
- Infections and febrile illness within 4 week before the first study drug administration
- Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them
- Inoculations with live vaccine within 8 weeks before the first study drug administration
- Signs of irritation or folliculitis or any other dermatological conditions in the test areas that would interfere with the planned assessments as judged by the Investigators
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 |
|---|---|---|
| BAY1003803 0.01% lipophilic creamTopical administration for 22 h per day | Drug | BAY1003803 |
| BAY1003803 0.1% lipophilic creamTopical administration for 22 h per day | Drug | BAY1003803 |
| BAY1003803 0.01% ointmentTopical administration for 22 h per day | Drug | BAY1003803 |
| BAY1003803 0.1% ointmentTopical administration for 22 h per day | Drug | BAY1003803 |
| Lipophilic cream vehicleTopical administration for 22 h per day | Drug | Placebo |
| Ointment vehicleTopical administration for 22 h per day | Drug | Placebo |
| Clobetasol propionateTopical administration for 22 h per day | Drug | Clobetasol propionate |
Primary outcome
Cortisol serum levels for safety
Time frame: Up to 2 weeks
Frequency of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 weeks
Nature of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 weeks
7 secondary outcomes
Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 1, single dose)
Time frame: Day 1 to 3 at 8:00 am
Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 2, multiple dose)
Time frame: Day 1 to 8 at 8:00 am
Maximum plasma concentration (Cmax) after single dose of BAY1003803
Time frame: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24 hours
Area under the plasma concentration vs. time curve from zero to infinity (AUC) after single dose of BAY1003803
Time frame: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24, 27, 31, 35, 39, 47 hours
Area under the curve from time zero to 22 hours [AUC(0-22)] after single dose of BAY1003803
Time frame: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22 hours
Maximum plasma concentration (Cmax,md) after multiple dose of BAY1003803
Time frame: At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6)
Area under the curve from time zero to 24 hours [AUC(0-24)md] after multiple dose of BAY1003803
Time frame: At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
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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.
Bayer Study Director study director
Bayer
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 BAY1003803 0.01% lipophilic cream, BAY1003803 0.1% lipophilic cream and BAY1003803 0.01% ointment in people with Psoriasis, run by Bayer at 1 site in Germany.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 8 Nov 2017. 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 Germany. 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. Some participants in this study may receive a placebo. 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 was stopped early. Results are not available in the source record.
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?
Cortisol serum levels for safety (time frame: Up to 2 weeks). The study lists 3 primary outcomes in all. 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 8 Nov 2017.