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

• Status: Completed
• Trial end date: 2017-08-23
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

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