Clinical trial NCT03965728: Study to Investigate Safety, Tolerability, Pharmacokinetics, and Drug-drug Interaction of Multiple Oral Doses of BAY1830839 in Healthy Male Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-05-29
Enrollment: 67
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of TEAEs
timeFrame: 7 days (period 1)
measure: Frequency of TEAEs
timeFrame: 18 days (period 2)
measure: Severity of TEAEs
timeFrame: 7 days (period 1)
measure: Severity of TEAEs
timeFrame: 18 days (period 2)
measure: AUC(0-24)md of BAY1830839 (QD and TID dosing)
timeFrame: Day 1 period 1
measure: AUC(0-12)md of BAY1830839 (BID dosing only)
timeFrame: Day 1 period 2
measure: Cmax,md of BAY1830839 after multiple dosing
timeFrame: 18 days (period 2)
measure: Cav of BAY1830839 after multiple dosing
timeFrame: 18 days (period 2)
measure: AUC of midazolam in plasma in presence/absence of BAY1830839
timeFrame: Day -1 period 1
measure: Cmax of midazolam in plasma in presence/absence of BAY1830839
timeFrame: Day -1 period 1
measure: AUC of methotrexate in plasma in presence/absence of BAY1830839
timeFrame: Day -1 period 1 (Dose group 3 of BAY1830839 only)
measure: Cmax of methotrexate in plasma in presence/absence of BAY1830839
timeFrame: Day -1 period 1 (Dose group 3 of BAY1830839 only)
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
References: