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

Bayer

Status and phase: Completed; Phase 1

Conditions: Pelvic Inflammatory Disease

Treatments: Drug: BAY1834845; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03054402

18384

2016-002668-15 (EudraCT Number)

Details and patient eligibility

About

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845 using a placebo controlled, randomized, single center design.

Enrollment: 70 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Dose escalation/BAY1834845

Experimental group

Description:

Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day

Treatment:

Drug: BAY1834845

Placebo

Placebo Comparator group

Description:

Subjects will receive a single dose of placebo in the morning of the PK profile day

Treatment:

Drug: Placebo