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OpenTrials
Completed

NCT Number: NCT03540615

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

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

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Berlin GmbH

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY1830839

Drug

Dose escalation in healthy male subjects

Placebo

Drug

Matching placebo

Primary outcomes

  1. AUC of BAY1830839 in plasma

    Time frame: Day 1, 2, 3, 4, 6 ,7, 9, and 12

    AUC: area under the plasma concentration vs time curve from zero to infinity after single dose.

  2. Cmax of BAY1830839 in plasma

    Time frame: Day 1, 2, 3, 4, 6 ,7, 9, and 12

    maximum observed drug concentration in plasma after single dose administration

  3. Frequency of treatment-emergent adverse events

    Time frame: From first application of study intervention up to 30 days after end of treatment

  4. Severity of treatment-emergent adverse events

    Time frame: From first application of study intervention up to 30 days after end of treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Increasing Single Oral Doses of BAY1830839 in Healthy Male Subjects

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 30, 2018
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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