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Trial record 1 of 1 for:    NCT03427788
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BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect

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ClinicalTrials.gov Identifier: NCT03427788
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : February 20, 2019
Information provided by (Responsible Party):

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Endometriosis Drug: BAY2328065 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : March 21, 2018
Actual Primary Completion Date : October 29, 2018
Actual Study Completion Date : February 11, 2019

Arm Intervention/treatment
Experimental: Verum
Study group 1-11 of BAY2328065 (increasing dose levels for study group 2-11)
Drug: BAY2328065
Doses from 2.25-700 mg once daily in an escalating manner as liquid service formulation (LSF) or tablets

Placebo Comparator: Placebo
Study group 1-11 of Placebo
Drug: Placebo
Matching placebo, once daily in an escalating manner as LSF or tablets

Primary Outcome Measures :
  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:

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

Information from the National Library of Medicine

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

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

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): NCT03427788

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CRS Clinical Research Services Berlin GmbH
Berlin, Germany, 13353
Sponsors and Collaborators
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03427788    
Other Study ID Numbers: 19250
2017-004056-38 ( EudraCT Number )
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

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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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