Healthy Volunteers
Conditions
Brief 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. In addition, the effects of BAY180839 on exploratory pharmacodynamics biomarkers in healthy participants will be investigated.
Interventions
DRUGBAY1830839
Tablet, oral.
DRUGPlacebo
Tablet, oral.
DRUGMidazolam
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
DRUGMethotrexate
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.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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: 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of TEAEs | 7 days (period 1) | TEAE: treatment-emergent adverse event |
| Severity of TEAEs | 7 days (period 1) | — |
| AUC(0-24)md of BAY1830839 (QD and TID dosing) | Day 1 period 1 | QD:once daily administration TID: three times daily administration |
| AUC(0-12)md of BAY1830839 (BID dosing only) | Day 1 period 2 | BID:twice daily administration |
| Cmax,md of BAY1830839 after multiple dosing | 18 days (period 2) | — |
| Cav of BAY1830839 after multiple dosing | 18 days (period 2) | — |
| AUC of midazolam in plasma in presence/absence of BAY1830839 | Day -1 period 1 | If AUC(tlast-∞) \>20% of AUC then AUC(0-tlast) will replace AUC. |
| Cmax of midazolam in plasma in presence/absence of BAY1830839 | Day -1 period 1 | — |
| AUC of methotrexate in plasma in presence/absence of BAY1830839 | Day -1 period 1 (Dose group 3 of BAY1830839 only) | If AUC(tlast-∞) \>20% of AUC then AUC(0-tlast) will replace AUC. |
| Cmax of methotrexate in plasma in presence/absence of BAY1830839 | Day -1 period 1 (Dose group 3 of BAY1830839 only) | — |
Countries
Germany
Outcome results
None listed