check_circleStudy Completed

Clinical Trials, Phase I as Topic

Bayer Identifier:

18183

ClinicalTrials.gov Identifier:

NCT02817100

EudraCT Number:

2016-000253-12

EU CT Number:

Not Available
First in human study to investigate the safety and tolerability, pharmacokinetics, itraconazole drug-drug-interaction and food effect of BAY1817080

Trial purpose

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled, randomized, single center design. In addition the influence of itraconazole and food on the pharmacokinetics of BAY1817080 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/m²
    - Race: White
  • - Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
    - Relevant diseases within the last 4 weeks prior to the first drug administration
    - Existing chronic diseases requiring medication
    - Known or suspected malignant tumors or carcinoma in situ (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment)
    - 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 any drugs which might influence the results of the trial within 14 days prior to administration or during the trial until follow-up including drugs which might affect the pharmacokinetics

Trial summary

Enrollment Goal
88
Trial Dates
July 2016 - August 2017
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY1817080
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
    date_rangeTime Frame:
    Up to 4 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Severity of treatment-emergent adverse events
    date_rangeTime Frame:
    Up to 4 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Randomized, placebo-controlled, double-blind, parallel group study to investigate the safety, tolerability and pharmacokinetics of increasing single oral doses (10 - 1500 mg, tablets) of BAY1817080 including the effect of food and itraconazole on the relative bioavailability of BAY1817080 in healthy men
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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