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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03965728
• Other study ID #: 19401
• Secondary ID: 2019-000632-26
• Status: Completed
• Phase: Phase 1
• Start date: June 5, 2019
• Est. completion date: May 11, 2022

Study information

• Verified date: May 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. In addition, the effects of BAY180839 on exploratory pharmacodynamics biomarkers in healthy participants will be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 11, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BAY1830839
Tablet, oral.
• Placebo
Tablet, oral.
• Midazolam
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
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.

Locations

Country	Name	City	State
Germany	Charité Research Organisation GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of TEAEs	TEAE: treatment-emergent adverse event	7 days (period 1)
Primary	Frequency of TEAEs		18 days (period 2)
Primary	Severity of TEAEs		7 days (period 1)
Primary	Severity of TEAEs		18 days (period 2)
Primary	AUC(0-24)md of BAY1830839 (QD and TID dosing)	QD:once daily administration TID: three times daily administration	Day 1 period 1
Primary	AUC(0-12)md of BAY1830839 (BID dosing only)	BID:twice daily administration	Day 1 period 2
Primary	Cmax,md of BAY1830839 after multiple dosing		18 days (period 2)
Primary	Cav of BAY1830839 after multiple dosing		18 days (period 2)
Primary	AUC of midazolam in plasma in presence/absence of BAY1830839	If AUC(tlast-8) >20% of AUC then AUC(0-tlast) will replace AUC.	Day -1 period 1
Primary	Cmax of midazolam in plasma in presence/absence of BAY1830839		Day -1 period 1
Primary	AUC of methotrexate in plasma in presence/absence of BAY1830839	If AUC(tlast-8) >20% of AUC then AUC(0-tlast) will replace AUC.	Day -1 period 1 (Dose group 3 of BAY1830839 only)
Primary	Cmax of methotrexate in plasma in presence/absence of BAY1830839		Day -1 period 1 (Dose group 3 of BAY1830839 only)

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