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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03493269
• Other study ID #: 18385
• Secondary ID: 2017-001817-10
• Status: Completed
• Phase: Phase 1
• Start date: April 16, 2018
• Est. completion date: February 5, 2021

Study information

• Verified date: February 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2).

To assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with psoriasis (Part 2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 5, 2021
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Psoriasis

Intervention

Drug:
• BAY1834845
Orally administered.

Other:
• Matching Placebo
Orally administered.

Drug:
• Midazolam
Part 1: Orally administered 1mg as a single dose.

Locations

Country	Name	City	State
Germany	Charité Research Organisation GmbH	Berlin
Germany	PAREXEL GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of treatment-emergent adverse events (TEAEs)	Part 1 in healthy male subject	Approximately 47 days
Primary	Severity of treatment-emergent adverse events (TEAEs)	Part 1 in healthy male subject	Approximately 47 days
Primary	Frequency of treatment-emergent adverse events (TEAEs)	Part 2: Patients with psoriasis	Approximately 84 days
Primary	Severity of treatment-emergent adverse events (TEAEs)	Part 2: Patients with psoriasis	Approximately 84 days
Primary	AUC(0-24)md of BAY1834845	Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing	Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2
Primary	AUC(0-12)md of BAY1834845	Part 1 AUC(0-12)md:AUC from zero to 12 hours after multiple dosing	Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1
Primary	Cmax,md of BAY1834845	Part 1 Cmax,md:Cmax(Maximum observed drug concentration, directly taken from analytical data) after multiple dosing	Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1
Primary	Cav,md of BAY1834845	Part 1 Cav:Average concentration within a dosing interval after multiple dosing	Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2
Primary	AUC(0-24)md of BAY1834845	Part 2: AUC(0-24)md: AUC from zero to 24 hours after multiple dosing	Part 2: one day between day 35 and 42
Primary	AUC(0-12)md of BAY1834845	Part 2: AUC(0-12)md: AUC from zero to 12 hours after multiple dosing	Part 2: one day between day 35 and 42
Primary	Cmax,md of BAY1834845	Part 2: Cmax,md:Cmax (Maximum observed drug concentration, directly taken from analytical data) after multiple dosing	Part 2: one day between day 35 and 42
Primary	Cav, md of BAY1834845	Part 2: Cav: Average concentration within a dosing interval after multiple dosing	Part 2: one day between day 35 and 42