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Completed

NCT Number: NCT03427788

BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect

This single center, double-blind, randomized study with up to 11 treatment groups evaluates the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of single ascending doses of BAY2328065

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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

  • Healthy male volunteers, aged 18 - 45 years
  • Body mass index (BMI): 18 ≤ BMI ≤ 30 kg/m²
  • Smoking less than 10 cigarettes / day
  • Signed informed consent
  • Use of an accepted method of contraception for the duration of the study.

Exclusion criteria

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, thyroid disorders or malignant tumors
  • Known severe allergies, non allergic drug reactions, or multiple drug allergies
  • Medication history: any regular medication, esp. drugs known to induce/inhibit liver enzymes or transporters
  • Clinically relevant findings in physical examination; ECG, blood pressure; laboratory values

Treatment and study plan

BAY2328065

Drug

Doses from 2.25-700 mg once daily in an escalating manner as liquid service formulation (LSF) or tablets

Placebo

Drug

Matching placebo, once daily in an escalating manner as LSF or tablets

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: Up to 8 days

    The frequency of adverse events collected from dosing until follow up, i.e. 8 days after dosing

  2. Severity of treatment-emergent adverse events

    Time frame: Up to 8 days

    The severity of adverse events collected from dosing until follow up, i.e. 8 days after dosing

    Severity is assessed by the following criteria:

    • Results in death
    • Is life-threatening
    • Requires inpatient hospitalization or prolongation of existing hospitalization
    • Results in persistent or significant disability / incapacity
    • Is a congenital anomaly / birth defect
    • Is another serious or important medical event as judged by the investigator

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BAY2328065 Including the Relative Bioavailability Between Solution and Tablet Formulation and the Effect of Food on the Pharmacokinetics of BAY2328065 in Healthy Men

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 9, 2018
Registry last updated
Feb 29, 2024

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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