Arthritis, RheumatoidPhase 1NCT03540615
BAY1830839: First in Man, Single Dose Escalation, Safety & Tolerability and Pharmacokinetics
A Phase 1 study testing BAY1830839 in people with Arthritis, Rheumatoid, run by Bayer at 1 site in Germany.
Trial summary
The primary objectives of this study are to investigate the safety and tolerability of increasing single oral doses of BAY 1830839 versus placebo under fasted conditions the pharmacokinetics after single ascending oral doses of BAY 1830839 under fasted conditions Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- BAY1830839
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jun 2018to 1 Aug 2019
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) : ≥18.5 and ≤30 kg/m*2
Who cannot join
- Relevant diseases within the last 4 weeks prior to the first study drug administration
- Febrile illness within 4 weeks before the first study drug administration
- Known hypersensitivity to the study drugs or components of the preparations
- Clinically relevant findings in the physical examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Increasing Single Oral Doses of BAY1830839 in Healthy Male Subjects
The primary objectives of this study are to investigate
- the safety and tolerability of increasing single oral doses of BAY 1830839 versus placebo under fasted conditions
- the pharmacokinetics after single ascending oral doses of BAY 1830839 under fasted conditions
- Conditions
- Arthritis, Rheumatoid
- Being tested
- BAY1830839, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1830839Drug
Dose escalation in healthy male subjects
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| BAY1830839 | Experimental | Single Dose escalations Receives: Drug: BAY1830839 |
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of BAY1830839 in plasma
AUC: area under the plasma concentration vs time curve from zero to infinity after single dose.
Measured: Day 1, 2, 3, 4, 6 ,7, 9, and 12
Cmax of BAY1830839 in plasma
maximum observed drug concentration in plasma after single dose administration
Measured: Day 1, 2, 3, 4, 6 ,7, 9, and 12
Frequency of treatment-emergent adverse events
Measured: From first application of study intervention up to 30 days after end of treatment
Severity of treatment-emergent adverse events
Measured: From first application of study intervention up to 30 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start28 Jun 2018
- Primary completion5 Feb 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation with safety assessment following each dose step.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540615
- Sponsor's protocol ID
- 19150
- Other IDs
- 2017-001496-23, 2017
- Status last verified
- Aug 2020
- First submitted
- 15 May 2018
- Last updated
- 5 Aug 2020
- 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 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Increasing Single Oral Doses of BAY1830839 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03540615
- Acronym / sponsor ID
- 19150
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 30 May 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.
The primary objectives of this study are to investigate
- the safety and tolerability of increasing single oral doses of BAY 1830839 versus placebo under fasted conditions
- the pharmacokinetics after single ascending oral doses of BAY 1830839 under fasted conditions
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Dose escalation with safety assessment following each dose step.
| Arm | Type | Receives |
|---|---|---|
| BAY1830839 | Experimental | Drug: BAY1830839Single Dose escalations |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) : ≥18.5 and ≤30 kg/m*2
Key exclusion criteria (4 listed)
- Relevant diseases within the last 4 weeks prior to the first study drug administration
- Febrile illness within 4 weeks before the first study drug administration
- Known hypersensitivity to the study drugs or components of the preparations
- Clinically relevant findings in the physical examination
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 |
|---|---|---|
| BAY1830839Dose escalation in healthy male subjects | Drug | BAY1830839 |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
AUC of BAY1830839 in plasma
Time frame: Day 1, 2, 3, 4, 6 ,7, 9, and 12
AUC: area under the plasma concentration vs time curve from zero to infinity after single dose.
Cmax of BAY1830839 in plasma
Time frame: Day 1, 2, 3, 4, 6 ,7, 9, and 12
maximum observed drug concentration in plasma after single dose administration
Frequency of treatment-emergent adverse events
Time frame: From first application of study intervention up to 30 days after end of treatment
Severity of treatment-emergent adverse events
Time frame: From first application of study intervention up to 30 days after end of treatment
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 5 Aug 2020.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BAY1830839 in people with Arthritis, Rheumatoid, 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 1 inclusion and 4 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 5 Aug 2020. 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 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?
AUC of BAY1830839 in plasma (time frame: Day 1, 2, 3, 4, 6 ,7, 9, and 12). The study lists 4 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 5 Aug 2020.