NCT03427788

BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect

Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BAY2328065 Including the Relative Bioavailability Between Solution and Tablet Formulation and the Effect of Food on the Pharmacokinetics of BAY2328065 in Healthy Men

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This single center, double-blind, randomized study with up to 11 treatment groups evaluates the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of single ascending doses of BAY2328065

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	BAY2328065	Doses from 2.25-700 mg once daily in an escalating manner as liquid service formulation (LSF) or tablets
DRUG	Placebo	Matching placebo, once daily in an escalating manner as LSF or tablets

Timeline

• Start date: 2018-03-21
• Primary completion: 2018-10-29
• Completion: 2019-02-11
• First posted: 2018-02-09
• Last updated: 2024-02-29

Locations

1 site across 1 country: Germany