A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 8 March 2021
• Main ID: NCT03493269
• Date of registration: 04/04/2018
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis
• Scientific title: A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Exploratory Pharmacodynamics of Multiple Oral Doses of BAY1834845 in Healthy Male Subjects and in Female and Male Patients With Psoriasis Over an Extended Treatment Duration
• Date of first enrolment: April 16, 2018
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03493269
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

Part 1 (healthy male subjects)

- Healthy male subjects, 18 to 50 years of age (inclusive), and in good health as
determined by medical history, physical examination, vital signs, electrocardiogram
(ECG), and laboratory tests at screening

- Body mass index (BMI) above or equal to 18.5 and lower or equal to 30 kg/m2 (BMI =
body weight (kg) / [height (m)]2 and a body weight above or equal 50 kg Part 2
(patients with psoriasis)

- Male patients, 18 to 70 years of age (inclusive) or female patients of non-child
bearing potential, 30 to 70 years of age (inclusive)

- Body mass index above or equal to 18.5 and lower or equal to 35 kg/m*2 and a body
weight above 50 kg

- A documented diagnosis of psoriasis, with a history of at least 6 months prior to
study drug administration. Moderate to severe plaque psoriasis at screening, defined
by: a) an involved body surface area (BSA) above or equal to 10% of BSA, b) a
Psoriasis Area and Severity Index (PASI) score of above or equal, 12 c) a Physician's
Global Assessment (PGA) score of above or equal 2.

Exclusion Criteria:

- History of hypersensitivity to any of the components of the study drug

- Any clinically relevant abnormal findings in safety laboratory parameters and ECG

- History of tuberculosis (TB) or active or latent tuberculosis

- Receipt of live or attenuated vaccine 90 days prior to the first dosing



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Psoriasis

Intervention(s)

Drug: Midazolam

Drug: BAY1834845

Other: Matching Placebo

Primary Outcome(s)

AUC(0-12)md of BAY1834845 [Time Frame: Part 2: one day between day 35 and 42]

Severity of treatment-emergent adverse events (TEAEs) [Time Frame: Approximately 47 days]

Frequency of treatment-emergent adverse events (TEAEs) [Time Frame: Approximately 84 days]

Cmax,md of BAY1834845 [Time Frame: Part 2: one day between day 35 and 42]

AUC(0-24)md of BAY1834845 [Time Frame: Part 2: one day between day 35 and 42]

Cav,md of BAY1834845 [Time Frame: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2]

AUC(0-12)md of BAY1834845 [Time Frame: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1]

Severity of treatment-emergent adverse events (TEAEs) [Time Frame: Approximately 84 days]

AUC(0-24)md of BAY1834845 [Time Frame: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2]

Cav, md of BAY1834845 [Time Frame: Part 2: one day between day 35 and 42]

Cmax,md of BAY1834845 [Time Frame: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1]

Frequency of treatment-emergent adverse events (TEAEs) [Time Frame: Approximately 47 days]

Secondary ID(s)

18385

2017-001817-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors