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Completed

NCT Number: NCT04027192

Study to Test the Safety of Increasing Multiple Doses of BAY2328065 Given by Mouth, How the Drug is Tolerated and Acts in the Human Body of Healthy Male Participants. Alteration of the Study Drug Effects by Another Drug and the Availability of the Drug Given in Different Formulations is Also Tested.

Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as tablet or solution over 12 days to healthy male participants. Researcher want to study how the body absorbs, breaks down and excrete the new drug, also when given together with a test meal. In addition the study will investigate changes that take place in the body when BAY2328065 is given together with another drug.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Berlin GmbH

Berlin, 13353, 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
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG and vital signs
  • Confirmation of the subject's health insurance coverage prior to the first screening examination/visit
  • Body mass index (BMI) within the range 18 and 30 kg/m^2 (inclusive)
  • Male participants who are sexually active must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study participant and one method used by the partner) and not to act as sperm donor until follow-up
  • 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 intervention will not be normal
  • Relevant diseases within the last 4 weeks prior to start of the first study intervention
  • Known severe allergies, non-allergic drug reactions, or multiple drug allergies
  • Existing chronic diseases requiring medication
  • History of cardiovascular disease
  • Known diseases as specified in protocol
  • Regular use of therapeutic or recreational drugs
  • Suspicion of drug or alcohol abuse
  • Smoking equal or more than 10 cigarettes/day
  • Clinically relevant findings in Electrocardiogram (ECG), blood pressure, heart rate, physical examination, laboratory examination
  • History of COVID-19
  • Contact with SARS-CoV-2 positive persons or COVID-19 patients within the last 4 weeks prior admission to the ward
  • Positive SARS-CoV-2 viral RNA test

Treatment and study plan

BAY2328065 LSF

Drug

20 mg/mL LSF (liquid service formulation), orally

BAY2328065 tablet

Drug

50 mg tablet, orally

Placebo LSF

Drug

Matching Placebo LSF, orally

Placebo Tablet

Drug

Matching Placebo tablet, orally

midazolam

Drug

1 mg per day, orally

Primary outcomes

  1. Number of subjects with treatment-emergent adverse events (TEAEs)

    Time frame: From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant

  2. Severity of TEAEs

    Time frame: From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant

  3. AUC(0-12)md (twice daily [BID])

    Time frame: From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065

  4. Cmax,md of BAY2328065

    Time frame: From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate Safety, Tolerability and Pharmacokinetics of Increasing Multiple Oral Doses of BAY2328065 Including the CYP3A4 Induction Potential of BAY2328065 and Randomized Cross-over Investigation of the Relative Bioavailability Between Solution and Tablet Formulation in Healthy Male Participants

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 19, 2019
Registry last updated
Nov 23, 2020

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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