check_circleStudy Completed

Clinical Trials, Phase I as Topic

Bayer Identifier:

18922

ClinicalTrials.gov Identifier:

NCT03212586

EudraCT Number:

2017-000978-11

EU CT Number:

Not Available
BAY 1902607: Single dose escalation, safety and tolerability, pharmacokinetics, bioavailability, food effect

Trial purpose

This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. In addition the influence of food on the pharmacokinetics of BAY1902607 and the bioavailability between different pharmaceutical formulations will be investigated

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy male subjects.
    - Age: 18 to 45 years (inclusive) .
    - Body mass index (BMI) : ≥18 and ≤30 kg/m^2.
    - Race: White.


  • - Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance.
    - Relevant diseases within the 4 weeks before the first drug administration.
    - Febrile illness within the week before the first taste test is conducted.

Trial summary

Enrollment Goal
72
Trial Dates
July 2017 - July 2018
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY1902607
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical Research Services Berlin GmbHBerlin, 13353, Germany

Primary Outcome

  • Number of subjects with treatment-emergent adverse events
    AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. AEs (except for those in the 60 mg dose group) were considered to be treatment-emergent if they had started or worsened within the interval from first study drug administration until the follow-up visit. For the 60 mg dose group, AEs were considered to be TEAEs if they had started or worsened within one of the following intervals: 1) from first administration of study medication in treatment period 1 to 15 days thereafter, 2) from second administration of study medication in treatment period 2 to 15 days thereafter, 3) from third administration of study medication in treatment period 3 to follow-up visit.
    date_rangeTime Frame:
    Up to 11 weeks
  • Number of subjects with severity of treatment-emergent adverse events
    AEs were considered to be TEAEs if they had started or worsened within the interval from first study drug administration until the follow-up visit (except for the 60 mg dose group: from first study drug administration in treatment period 1 to 15 days thereafter; from second study drug administration in treatment period 2 to 15 days thereafter; from third study drug administration in treatment period 3 to follow-up visit). Classification of the intensity: Mild (usually transient and might have required only minimal treatment or therapeutic intervention, did not generally interfere with usual activities of daily living), Moderate (usually alleviated with additional specific therapeutic intervention, interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the research subject), Severe (required intensive therapeutic intervention, interrupted usual activities of daily living, or significantly affected clinical status).
    date_rangeTime Frame:
    Up to 11 weeks

Trial design

Randomized, placebo-controlled, double-blind, parallel-group study to investigate the safety, tolerability and pharmacokinetics of increasing single oral doses of BAY1902607 including the relative bioavailability between different pharmaceutical formulations and the effect of food on the pharmacokinetics of BAY1902607 in healthy men
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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