NCT02817100

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Clinical Trials, Phase I as Topic

Interventions

Type	Name	Description
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 \[Continental breakfast\])
DRUG	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 \[Continental breakfast\])
DRUG	Itraconazole	Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)

Timeline

• Start date: 2016-07-22
• Primary completion: 2017-05-11
• Completion: 2017-08-23
• First posted: 2016-06-29
• Last updated: 2017-09-06

Locations

1 site across 1 country: Germany