check_circleStudy Completed

Pelvic Inflammatory Disease

Bayer Identifier:

18384

ClinicalTrials.gov Identifier:

NCT03054402

EudraCT Number:

2016-002668-15

EU CT Number:

Not Available
First in human study to investigate the safety, tolerability, pharmacokinetics and to explore pharmacodynamics of BAY1834845

Trial purpose

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845 using a placebo controlled, randomized, single center design.

Key Participants Requirements

Sex

Male

Age

18 - 50 Years
  • - Healthy male subject
    - Age: 18 to 50 years (inclusive) at the first screening visit
    - Body mass index (BMI) : 18.5 ≤ BMI ≤ 30 kg/m²

  • - Clinically relevant findings in the physical examination
    - Relevant diseases within the last 4 weeks prior to the first study drug administration
    - 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
    - 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

Trial summary

Enrollment Goal
70
Trial Dates
February 2017 - March 2018
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY1834845
Accepts Healthy Volunteer
Yes

Where to participate

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

Primary Outcome

  • Frequency of treatment-emergent adverse events (TEAEs)
    AEs are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.
    date_rangeTime Frame:
    Up to 25 days after last drug administration
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    Safety Issue:
    Yes
  • Severity of treatment-emergent adverse events
    The intensity of an AE is classified according to the following categories: - Mild - Moderate - Severe
    date_rangeTime Frame:
    Up to 25 days after last drug administration
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    Safety Issue:
    Yes
  • Area under the plasma concentration vs. time curve (AUC)
    AUC from zero to infinity after single dose if possible or from time 0 to the last data point above lower limit of quantification (AUC (0-tlast)
    date_rangeTime Frame:
    Baseline to up to 14 days post drug administration
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    Safety Issue:
    No
  • Maximum drug concentration in plasma after single dose administration (Cmax)
    Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845
    date_rangeTime Frame:
    Baseline to up to 14 days post drug administration
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    Safety Issue:
    No

Trial design

Randomized, placebo-controlled, double-blind study to investigate the safety, tolerability, pharmacokinetics and to explore pharmacodynamics of increasing single oral doses of BAY1834845 including relative bioavailability of a liquid versus a solid dosage in healthy male volunteers
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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