NCT03212586

BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect

Randomized, Placebo-controlled, Double-blind, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BAY1902607 Including the Relative Bioavailability Between Different Pharmaceutical Formulations and the Effect of Food on the Pharmacokinetics of BAY1902607 in Healthy Men

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. In addition the influence of food on the pharmacokinetics of BAY1902607 and the bioavailability between different pharmaceutical formulations will be investigated

Conditions

• Clinical Trials, Phase I as Topic

Interventions

Type	Name	Description
DRUG	BAY1902607	Escalating doses of BAY1902607; single dose administration; different dosage forms (redosing of BAY1902607 at dose group 4 with different formulations; redosing of BAY1902607 solid formulation at dose group 4 together with food)
DRUG	Placebo	Escalating doses of Placebo; single dose administration; different dosage forms (redosing of Placebo at dose group 4 with different formulations; redosing of Placebo solid formulation at dose group 4 together with food)

Timeline

• Start date: 2017-07-18
• Primary completion: 2018-05-03
• Completion: 2018-07-27
• First posted: 2017-07-11
• Last updated: 2019-05-14

Locations

1 site across 1 country: Germany