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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054402
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pelvic Inflammatory Disease Drug: BAY1834845 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : February 13, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : March 29, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose escalation/BAY1834845
Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day
Drug: BAY1834845
Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group

Placebo Comparator: Placebo
Subjects will receive a single dose of placebo in the morning of the PK profile day
Drug: Placebo
Single dose of placebo




Primary Outcome Measures :
  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



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
Criteria

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

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): NCT03054402


Locations
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Germany
CRS Clinical Research Services Berlin GmbH
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03054402     History of Changes
Other Study ID Numbers: 18384
2016-002668-15 ( EudraCT Number )
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 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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Pelvic Inflammatory Disease
Pelvic Infection
Infection
Adnexal Diseases
Genital Diseases, Female