AzTrials
AzTrials

Healthy VolunteersPhase 1NCT03965728

Study to Investigate Safety, Tolerability, Pharmacokinetics, and Drug-drug Interaction of Multiple Oral Doses of BAY1830839 in Healthy Male Participants

A Phase 1 study testing BAY1830839, Midazolam and Methotrexate in people with Healthy Volunteers, run by Bayer at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this study is to investigate safety, tolerability and pharmacokinetics of increasing repeated oral doses of BAY1830839 in healthy male participants including the investigation of any potential drug-drug interactions of BAY1830839 with midazolam and methotrexate. 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
Healthy Volunteers
What is being tested?
BAY1830839, Midazolam and Methotrexate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
1 siteGermany
Study dates
5 Jun 2019to 11 May 2022
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

  • Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
  • Overtly healthy as determined by medical evaluation including (medical and surgical history, physical examination, laboratory tests, ECG, vital signs).
  • Confirmation of the participant's health insurance coverage prior to the first screening examination/visit.
  • Body Mass Index (BMI): above or equal 18.5 and below or equal 30.0 kg/m² at screening
  • Male
  • Study participants of reproductive potential must agree to utilize two reliable and acceptable methods of contraception simultaneously when sexually active. This applies for the time period between admission to the study site until 12 weeks after the last administration of the study intervention. The following contraceptive methods will be regarded as adequate in the context of this study:
Show all 13Show fewer
  • condoms (male or female) with or without a spermicidal agent;
  • diaphragm or cervical cap with spermicide;
  • intra-uterine device;
  • hormone-based contraception.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • The informed consent must be signed before any study specific tests or procedures are done.
  • Ability to understand and follow study-related instructions

Who cannot join

  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
  • Relevant diseases within the last 4 weeks prior to the first study administration of study intervention.
  • Febrile illness within 4 weeks before the first study administration of study intervention.
  • Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study.
  • Known severe allergies, significant non-allergic drug reactions, or multiple drug allergies, e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids, or urticaria.
  • Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before first study drug administration, e.g. an investigational drug; any drug known to induce liver enzymes (e.g. dexamethasone, barbiturates, rifampicin, anticonvulsants, griseofulvin, St. John's Wort [Hypericum perforatum]).
  • History of COVID-19 as patients with a history of severe COVID-19 infection.
  • Incomplete SARS-CoV-2 vaccination

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité Research Organisation GmbH

    Berlin, 10117

Other trials in Germany

About this study

Official title: Multiple Dose Escalation Study in a Randomized, Double-blind, Placebo-controlled Design to Investigate Safety, Tolerability, Pharmacokinetics, Drug-drug Interaction and Exploratory Pharmacodynamics of Multiple Oral Doses of BAY1830839 in Healthy Male Participants

The aim of this study is to investigate safety, tolerability and pharmacokinetics of increasing repeated oral doses of BAY1830839 in healthy male participants including the investigation of any potential drug-drug interactions of BAY1830839 with midazolam and methotrexate. In addition, the effects of BAY180839 on exploratory pharmacodynamics biomarkers in healthy participants will be investigated.

Being tested
BAY1830839, Placebo, Midazolam, Methotrexate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY1830839Drug

    Tablet, oral.

  • PlaceboDrug

    Tablet, oral.

  • MidazolamDrug

    For all dose steps. Oral. Two single doses. One dose administered during pre-dose in Period 1 and the second dose administered on the last day of treatment with BAY1830839 or placebo in Period 2

  • MethotrexateDrug

    Only for Dose 3 step. Tablet, oral. Two single doses. One dose administered during pre-dose in Period 1 and the second dose administered on the last day of treatment with BAY1830839 or placebo in Period 2.

Study groups in NCT03965728
Study groupRoleWhat they receive
BAY1830839 armExperimentalPeriod 1: Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6, single dose. Period 2: Dose 1, Dose 2 and Dose 3, once daily over 10 days. Dose 4 and Dose 5, twice daily over 10 days. Dose 6, single dose on Day 1, three times daily (TID) for 9 days (Days 2-10).
Receives: Drug: BAY1830839; Drug: Midazolam; Drug: Methotrexate
Placebo armPlacebo comparatorPlacebo tablets matching BAY1830839
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of TEAEs

    TEAE: treatment-emergent adverse event

    Measured: 7 days (period 1)

  2. Frequency of TEAEs

    Measured: 18 days (period 2)

  3. Severity of TEAEs

    Measured: 7 days (period 1)

  4. Severity of TEAEs

    Measured: 18 days (period 2)

  5. AUC(0-24)md of BAY1830839 (QD and TID dosing)

    QD:once daily administration TID: three times daily administration

    Measured: Day 1 period 1

  6. AUC(0-12)md of BAY1830839 (BID dosing only)

    BID:twice daily administration

    Measured: Day 1 period 2

  7. Cmax,md of BAY1830839 after multiple dosing

    Measured: 18 days (period 2)

  8. Cav of BAY1830839 after multiple dosing

    Measured: 18 days (period 2)

  9. AUC of midazolam in plasma in presence/absence of BAY1830839

    If AUC(tlast-∞) >20% of AUC then AUC(0-tlast) will replace AUC.

    Measured: Day -1 period 1

  10. Cmax of midazolam in plasma in presence/absence of BAY1830839

    Measured: Day -1 period 1

  11. AUC of methotrexate in plasma in presence/absence of BAY1830839

    If AUC(tlast-∞) >20% of AUC then AUC(0-tlast) will replace AUC.

    Measured: Day -1 period 1 (Dose group 3 of BAY1830839 only)

  12. Cmax of methotrexate in plasma in presence/absence of BAY1830839

    Measured: Day -1 period 1 (Dose group 3 of BAY1830839 only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2019
  2. Study start5 Jun 2019
  3. Primary completion21 Jan 2022
  4. Study completion11 May 2022

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03965728
Sponsor's protocol ID
19401
Other IDs
2019-000632-26, 2019
Status last verified
May 2023
First submitted
27 May 2019
Last updated
9 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY1830839, Midazolam and Methotrexate in people with Healthy Volunteers, 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 13 inclusion and 8 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 9 May 2023. 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?

Frequency of TEAEs (time frame: 7 days (period 1)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03965728.

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 9 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in