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NCT Number: NCT03054402

First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845

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.

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Key information

Conditions

Pelvic Inflammatory Disease Adnexal Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Pelvic Infection 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 subject
  • Age: 18 to 50 years (inclusive) at the first screening visit
  • Body mass index (BMI) : 18.5 ≤ BMI ≤ 30 kg/m²

Exclusion criteria

  • 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

Treatment and study plan

BAY1834845

Drug

Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group

Placebo

Drug

Single dose of placebo

Primary outcomes

  1. Frequency of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 25 days after last drug administration

    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.

  2. Severity of treatment-emergent adverse events

    Time frame: Up to 25 days after last drug administration

    The intensity of an AE is classified according to the following categories:

    • Mild
    • Moderate
    • Severe

  3. Area under the plasma concentration vs. time curve (AUC)

    Time frame: Baseline to up to 14 days post drug administration

    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)

  4. Maximum drug concentration in plasma after single dose administration (Cmax)

    Time frame: Baseline to up to 14 days post drug administration

    Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 15, 2017
Registry last updated
Mar 27, 2019

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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