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Completed

NCT Number: NCT03965728

Study to Investigate Safety, Tolerability, Pharmacokinetics, and Drug-drug Interaction 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Charité Research Organisation GmbH

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY1830839

Drug

Tablet, oral.

Placebo

Drug

Tablet, oral.

midazolam

Drug

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

methotrexate

Drug

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.

Primary outcomes

  1. Frequency of TEAEs

    Time frame: 7 days (period 1)

    TEAE: treatment-emergent adverse event

  2. Frequency of TEAEs

    Time frame: 18 days (period 2)

  3. Severity of TEAEs

    Time frame: 7 days (period 1)

  4. Severity of TEAEs

    Time frame: 18 days (period 2)

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

    Time frame: Day 1 period 1

    QD:once daily administration TID: three times daily administration

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

    Time frame: Day 1 period 2

    BID:twice daily administration

  7. Cmax,md of BAY1830839 after multiple dosing

    Time frame: 18 days (period 2)

  8. Cav of BAY1830839 after multiple dosing

    Time frame: 18 days (period 2)

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

    Time frame: Day -1 period 1

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

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

    Time frame: Day -1 period 1

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 29, 2019
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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