First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03054402
• Date of registration: 13/02/2017
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845
• Scientific title: Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of Increasing Single Oral Doses of BAY1834845 Including Relative Bioavailability of a Liquid Versus a Solid Dosage in Healthy Male Volunteers
• Date of first enrolment: February 13, 2017
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03054402
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male subject

- Age: 18 to 50 years (inclusive) at the first screening visit

- Body mass index (BMI) : 18.5 = BMI = 30 kg/m²

Exclusion Criteria:

- Clinically relevant findings in the physical examination

- Relevant diseases within the last 4 weeks prior to the first study drug administration

- Incompletely cured pre-existing diseases for which it can be assumed that the
absorption, distribution, metabolism, elimination and effects of the study drugs will
not be normal

- Use of systemic or topical medicines or substances which oppose the study objectives
or which might influence them within 4 weeks before first study drug administration



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Pelvic Inflammatory Disease

Intervention(s)

Drug: BAY1834845

Drug: Placebo

Primary Outcome(s)

Frequency of treatment-emergent adverse events (TEAEs) [Time Frame: Up to 25 days after last drug administration]

Maximum drug concentration in plasma after single dose administration (Cmax) [Time Frame: Baseline to up to 14 days post drug administration]

Severity of treatment-emergent adverse events [Time Frame: Up to 25 days after last drug administration]

Area under the plasma concentration vs. time curve (AUC) [Time Frame: Baseline to up to 14 days post drug administration]

Secondary ID(s)

2016-002668-15

18384

Source(s) of Monetary Support

Please refer to primary and secondary sponsors