BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect

Randomized, Placebo-controlled, Double-blind, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BAY1902607 Including the Relative Bioavailability Between Different Pharmaceutical Formulations and the Effect of Food on the Pharmacokinetics of BAY1902607 in Healthy Men

This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. In addition the influence of food on the pharmacokinetics of BAY1902607 and the bioavailability between different pharmaceutical formulations will be investigated

Study Overview

• Status: Completed
• Conditions: Clinical Trials, Phase I as Topic
• Intervention / Treatment: Drug: BAY1902607; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • CRS Clinical Research Services Berlin GMBH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects.
• Age: 18 to 45 years (inclusive) .
• Body mass index (BMI) : ≥18 and ≤30 kg/m^2.
• Race: White.

Exclusion Criteria:

• Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance.
• Relevant diseases within the 4 weeks before the first drug administration.
• Febrile illness within the week before the first taste test is conducted.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dose escalation BAY1902607; Dose 1 to 9 of BAY1902607	Drug: BAY1902607; Escalating doses of BAY1902607; single dose administration; different dosage forms (redosing of BAY1902607 at dose group 4 with different formulations; redosing of BAY1902607 solid formulation at dose group 4 together with food)
PLACEBO_COMPARATOR: Dose escalation Placebo; Dose 1 to 9 of matching placebo	Drug: Placebo; Escalating doses of Placebo; single dose administration; different dosage forms (redosing of Placebo at dose group 4 with different formulations; redosing of Placebo solid formulation at dose group 4 together with food)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with treatment-emergent adverse events	AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. AEs (except for those in the 60 mg dose group) were considered to be treatment-emergent if they had started or worsened within the interval from first study drug administration until the follow-up visit. For the 60 mg dose group, AEs were considered to be TEAEs if they had started or worsened within one of the following intervals: 1) from first administration of study medication in treatment period 1 to 15 days thereafter, 2) from second administration of study medication in treatment period 2 to 15 days thereafter, 3) from third administration of study medication in treatment period 3 to follow-up visit.	Up to 11 weeks
Number of subjects with severity of treatment-emergent adverse events	AEs were considered to be TEAEs if they had started or worsened within the interval from first study drug administration until the follow-up visit (except for the 60 mg dose group: from first study drug administration in treatment period 1 to 15 days thereafter; from second study drug administration in treatment period 2 to 15 days thereafter; from third study drug administration in treatment period 3 to follow-up visit). Classification of the intensity: Mild (usually transient and might have required only minimal treatment or therapeutic intervention, did not generally interfere with usual activities of daily living), Moderate (usually alleviated with additional specific therapeutic intervention, interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the research subject), Severe (required intensive therapeutic intervention, interrupted usual activities of daily living, or significantly affected clinical status).	Up to 11 weeks

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 18, 2017
• Primary Completion (ACTUAL): May 3, 2018
• Study Completion (ACTUAL): July 27, 2018

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (ACTUAL): July 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 18922; 2017-000978-11 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No