Single/Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY1101042 Given as 5 mg MR Tablet After Single Oral Dosing Followed by Once Daily Dosing for 7 Days in 12 Healthy Male Subjects Per Dose Step in a Randomized, Placebo Controlled, Single Blind, Group Comparison Design
Phase of Trial: Phase I
Latest Information Update: 25 Jul 2018
At a glance
- Drugs BAY 1101042 (Primary)
- Indications Unspecified
- Focus Adverse reactions
- Sponsors Bayer
- 16 Jul 2018 Planned number of patients changed from 72 to 108.
- 16 Jul 2018 Planned End Date changed from 6 Jun 2018 to 26 Apr 2019.
- 16 Jul 2018 Planned primary completion date changed from 8 May 2018 to 21 Mar 2019.