BAY1830839: First in Man, Single Dose Escalation, Safety & Tolerability and Pharmacokinetics

Bayer

Status and phase: Completed; Phase 1

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Placebo; Drug: BAY1830839

Study type: Interventional

Funder types: Industry

Identifiers

NCT03540615

2017-001496-23 (EudraCT Number)

19150

Details and patient eligibility

About

The primary objectives of this study are to investigate

• the safety and tolerability of increasing single oral doses of BAY 1830839 versus placebo under fasted conditions
• the pharmacokinetics after single ascending oral doses of BAY 1830839 under fasted conditions

Enrollment: 64 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) : ≥18.5 and ≤30 kg/m*2

Exclusion criteria

• Relevant diseases within the last 4 weeks prior to the first study drug administration
• Febrile illness within 4 weeks before the first study drug administration
• Known hypersensitivity to the study drugs or components of the preparations
• Clinically relevant findings in the physical examination

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

64 participants in 2 patient groups, including a placebo group

BAY1830839

Experimental group

Description:

Single Dose escalations

Treatment:

Drug: BAY1830839

Placebo

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Placebo