Study to Gather Information on the Influence of BAY1817080 on the Electrical Activity of the Heart Recorded by an Electrocardiogram in Healthy Male and Female Participants

NCT04423744 | Completed Phase 1

• 2 other identifiers: 211982020-000516-29
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, researchers want to find whether the study drug BAY1817080 has an effect on the electrocardiogram (ECG). 40 healthy male or female participants with the age of 18 to 65 years will be enrolled into this study. The ECG of the participants will be monitored closely by the researchers to detect any change after intake of the study medication.

Conditions

Cough; Endometriosis; Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 therapeutic dose

  Baseline and Day 3

• Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 supra-therapeutic dose

  Baseline and Day 3

Secondary Outcomes (8)

• Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after a single oral dose of moxifloxacin

  Baseline and Day 3

• Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose

  Baseline and Day 3

• Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after a single oral dose of moxifloxacin

  Baseline and Day 3

• AUC(0-24)md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose

  Predose and up to 24 hours after last dose of BAY1817080 at Day 3

• AUC after a single oral dose of moxifloxacin

  Predose and up to 24 hours after single dose of moxifloxacin at Day 3

Study Arms (4)

Intervention ABCD

EXPERIMENTAL

Intervention A: Day 1 and 2: Supra-therapeutic dose of BAY1817080, three times daily (tid) Day 3: Supra-therapeutic dose of BAY1817080 and placebo to moxifloxacin, once Intervention B: Day 1 and 2: therapeutic dose of BAY1817080 and placebo to BAY1817080, tid Day 3: therapeutic dose of BAY1817080, placebo to BAY1817080 and placebo to moxifloxacin, once Intervention C: Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and moxifloxacin, once Intervention D: Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and placebo to moxifloxacin, once Subjects will receive intervention A, B, C and D sequentially. The washing-out period between each intervention is at least 14 days

Drug: BAY1817080; Drug: Moxifloxacin; Drug: Placebo

Intervention BCDA

EXPERIMENTAL

Subjects will receive intervention B, C, D and A sequentially. The washing-out period between each intervention is at least 14 days

Drug: BAY1817080; Drug: Moxifloxacin; Drug: Placebo

Intervention CDAB

EXPERIMENTAL

Subjects will receive intervention C, D, A and B sequentially. The washing-out period between each intervention is at least 14 days

Drug: BAY1817080; Drug: Moxifloxacin; Drug: Placebo

Intervention DABC

EXPERIMENTAL

Subjects will receive intervention D, A, B and C sequentially. The washing-out period between each intervention is at least 14 days Note: the intervention sequences in this and above arms are examples, the actual order of intervention may differ from these examples

Drug: BAY1817080; Drug: Moxifloxacin; Drug: Placebo

Interventions

BAY1817080 DRUG

Film-coated tablet

Intervention ABCD; Intervention BCDA; Intervention CDAB; Intervention DABC

Moxifloxacin DRUG

Film-coated tablet

Intervention ABCD; Intervention BCDA; Intervention CDAB; Intervention DABC

Placebo DRUG

Matched placebo as film-coated tablet

Intervention ABCD; Intervention BCDA; Intervention CDAB; Intervention DABC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men must be 18 to 65 years of age inclusive, women must be 40 to 65 years of age inclusive at the time of signing the informed consent
• Female participants have to be in postmenopausal state
• Body mass index (BMI) within the range 18.0-32.0 kg/m\^2 (inclusive)
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG, and vital signs
• lead electrocardiogram recording without signs of clinically relevant pathology

You may not qualify if:

• A history of relevant diseases of vital organs, of the central nervous system or other organs
• Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal
• Known hypersensitivity to the study interventions (active substances, or excipients of the preparations)
• Known severe allergies e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant nonallergic drug reactions
• Febrile illness within 1 week before study intervention administration
• Known or suspected disorder of the liver (e.g. bile secretion/flow disorder, Morbus Meulengracht (Gilbert´s syndrome), drug-induced hepatitis etc.)
• History of disorder of the pancreas or evidence for past or present pancreas disorders indicated by clinically relevant lipase or amylase levels above ULN and typical clinical symptoms of pancreas disorders as e.g. upper abdominal pain spread to the back, weight loss, fatty or pale stools
• History of known or suspected malignant tumors
• History of hypokalemia
• Use of CYP3A4 inhibitors from 14 days before study intervention administration until the last study visit
• Use of CYP3A4 inducers within 4 weeks (or at least five half-lives of the active substance whatever is longer) prior to study intervention administration
• Smoking more than 10 cigarettes daily
• Suspicion of drug or alcohol abuse
• Plasmapheresis within 3 months prior to study drug administration
• Excluded physical therapies that might alter the PK or safety results of the study (e.g. physiotherapy, acupuncture, etc.) from 7 days before first study drug administration until follow-up

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Cough; Endometriosis; Urinary Bladder, Overactive

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 9, 2020
• Study Start: June 18, 2020
• Primary Completion: November 9, 2020
• Study Completion: January 21, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)