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

Clinical Trials, Phase I as Topic Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817100
• Other study ID #: 18183
• Secondary ID: 2016-000253-12
• Status: Completed
• Phase: Phase 1
• First received: June 27, 2016
• Last updated: September 4, 2017
• Start date: July 22, 2016
• Est. completion date: August 23, 2017

Study information

• Verified date: September 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 23, 2017
• Est. primary completion date: May 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Trials, Phase I as Topic

Intervention

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

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Berlin GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of treatment-emergent adverse events		Up to 4 months
Primary	Severity of treatment-emergent adverse events		Up to 4 months

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