NCT03773068

A Study in Healthy Volunteers Investigating How Quickly and to What Extent BAY1817080 is Taken up, Distributed, Broken Down and Eliminated From the Body, as Well as the Difference Between 2 Different Types of Tablets of BAY1817080 and the Difference Between Oral Dose and Dose in the Vein

Open Label, Partially Randomized, Cross-over Study to Determine the Absolute Bioavailability and Pharmacokinetics of BAY1817080 Using a Simultaneous Anticipated Therapeutic Oral Dose Along With an i.v. [13C715N]-Labeled Microtracer and to Investigate the Relative Bioavailability of Two Formulations Given Under Different Diets at 2 Dose Levels in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to investigate how quickly and to what extent BAY1817080 is absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of BAY1817080 administered as tablets will be compared to the pharmacokinetics of BAY1817080 administered as intravenous (iv; in the vein) infusion (this is called absolute bioavailability). Furthermore, 2 different types of tablets with BAY1817080 (Formulation A and Formulation B) will be compared with regard to pharmacokinetics (this is called relative bioavailability). The effect of a meal on the pharmacokinetics of BAY1817080 administered as tablets will be investigated as well. Finally, it will also be investigated how safe BAY1817080 is and how well BAY1817080 is tolerated.

Conditions

• Biological Availability

Interventions

Type	Name	Description
DRUG	BAY1817080 - Formulation A	Formulation A
DRUG	BAY1817080 - Formulation B	Formulation B
DRUG	[13C715N]-BAY 181708 stable isotope label (SIL)	0.1 mg \[13C715N\]-BAY181708, 15 minutes i.v. infusion at the estimated tmax after administration of Formulation B

Timeline

• Start date: 2018-12-13
• Primary completion: 2019-06-21
• Completion: 2019-08-12
• First posted: 2018-12-12
• Last updated: 2019-08-19

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study