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Completed

NCT Number: NCT02817100

First in Human Study to Investigate the Safety and Tolerability, Pharmacokinetics, Itraconazole Drug-drug-interaction and Food Effect of BAY1817080

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.

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Key information

Conditions

Clinical Trials, Phase I as Topic

Age range

18 year–45 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 subjects
  • Age: 18 to 45 years (inclusive)
  • Body mass index (BMI) : ≥18 and ≤30 kg/m²
  • Race: White

Exclusion criteria

  • 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

Treatment and study plan

BAY1817080

Drug

Study part 1: Escalating doses of BAY1817080; single dose administration; solid dosage form (redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food [American breakfast]) Study part 2: Escalating doses of BAY1817080; single dose administration together with an American breakfast; solid dosage form (redosing of BAY1817080 at dose group 1, 2 and 4 together with food [Continental breakfast])

Placebo

Drug

Study part 1: Escalating doses of respective placebos; single dose administration; solid dosage form (redosing of placebo at dose group 1 and 2 together with itraconazole; redosing of placebo at dose group 4 together with food [American breakfast]) Study part 2: Escalating doses of respective placebos; single dose administration together with an American breakfast; solid dosage form (redosing of placebo at dose group 1, 2 and together with food [Continental breakfast])

Itraconazole

Drug

Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)

Primary outcomes

  1. Frequency of treatment-emergent adverse events

    Time frame: Up to 4 months

  2. Severity of treatment-emergent adverse events

    Time frame: Up to 4 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2016
Registry last updated
Sep 6, 2017

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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