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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965728
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: BAY1830839 Drug: Placebo Drug: Midazolam Drug: Methotrexate Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Actual Study Start Date : June 5, 2019
Estimated Primary Completion Date : March 18, 2021
Estimated Study Completion Date : April 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Dose group 1 of BAY1830839
Period 1: Dose 1, single dose Period 2: Dose 1, once daily over 10 days.
Drug: BAY1830839
Tablet, oral.

Drug: Midazolam
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

Experimental: Dose group 2 of BAY1830839
Period 1: Dose 2, single dose Period 2: Dose 2, once daily over 10 days.
Drug: BAY1830839
Tablet, oral.

Drug: Midazolam
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

Experimental: Dose group 3 of BAY1830839
Period 1: Dose 3, single dose Period 2: Dose 3, once daily over 10 days.
Drug: BAY1830839
Tablet, oral.

Drug: Midazolam
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

Drug: Methotrexate
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.

Experimental: Dose group 4 of BAY1830839
Period 1: Dose 4, single dose Period 2: Dose 4, twice daily over 10 days.
Drug: BAY1830839
Tablet, oral.

Drug: Midazolam
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

Experimental: Dose group 5 of BAY1830839
Period 1: Dose 5, single dose Period 2: Dose 5, twice daily over 10 days.
Drug: BAY1830839
Tablet, oral.

Drug: Midazolam
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

Placebo Comparator: Placebo
Placebo tablets matching BAY1830839
Drug: Placebo
Tablet, oral.

Drug: Midazolam
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

Drug: Methotrexate
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 Outcome Measures :
  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 dosing) [ Time Frame: Day 1 period 1 ]
    QD:once 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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]).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965728


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Germany
Charité Research Organisation GmbH Recruiting
Berlin, Germany, 10117
Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03965728    
Other Study ID Numbers: 19401
2019-000632-26 ( EudraCT Number )
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Methotrexate
Midazolam
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents