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Study on the Safety of Drug BAY1817080 at Different Doses and the Way the Body Absorbs and Eliminates the Drug in Japanese Healthy Adult Male Participants

Primary Purpose

Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
BAY1817080
Matching Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endometriosis Related Pain focused on measuring Refractory or unexplained chronic cough, Healthy volunteers, P2X3 receptor antagonist

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant must be 20 to 45 years of age inclusive, at the time of signing the informed consent.
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ECG.
  • Non-smoker for at least 6 months and with a pack year history of equal to or less than 5 years
  • Race: Japanese.
  • BMI: above or equal 18.0 and below or equal 30.0 kg/m² at the screening visit.
  • Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the ICF and 90 days after the last administration of study intervention.

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 potentially interfering with the study objectives within the 4 weeks before screening or between screening and randomization
  • Any febrile illness within the four weeks before screening or between screening and randomization
  • Any known presence or history of severe allergies, non-allergic drug reactions, or multiple drug allergies
  • Known or suspected malignant tumors or carcinoma in situ
  • Any history of malignant tumors
  • Any known or suspected benign tumors of the liver and/or pituitary gland
  • Known liver disease: existing acute or chronic progressive liver disease, e.g. disturbance of bilirubin excretion (Dubin-Johnson and Rotor syndromes); disturbances of bile secretion and flow (cholestasis); presence or history of liver tumors (benign or malignant). Note: According to this criterion there must have been an interval of at least 6 months between the subsidence of any viral hepatitis (normalization of liver parameters) and the screening visit.

Sites / Locations

  • Hakata Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Dose escalation BAY1817080

Dose expansion BAY1817080

Dose escalation Placebo

Dose expansion Placebo

Arm Description

Participants receive dose 1 to 3 of BAY1817080 as a single dose on Day 1.

Participants receive the highest dose 3 of BAY1817080 twice daily (BID) from Day 1 until Day 13 and a single dose on Day 14.

Participants receive placebo tablets orally as a single dose on Day 1.

Participants receive placebo tablets as BID multiple doses from Day 1 until Day 13 and as a single dose on Day 14.

Outcomes

Primary Outcome Measures

Frequency of treatment-emergent adverse events (TEAE) after single dose of BAY1817080
Severity of treatment-emergent adverse events after single dose of BAY1817080
Frequency of treatment-emergent adverse events after multiple doses of BAY1817080
Severity of treatment-emergent adverse events after multiple doses of BAY1817080

Secondary Outcome Measures

Maximum plasma concentration of BAY1817080 after single dose (Cmax)
Area under the concentration-time curve of BAY1817080 after single dose (AUC)
In the case of extrapolated portion of AUC exceeding20% [%AUC(tlast-∞) >20%], the parameter AUC(0-tlast) may be evaluated as main parameter
Maximum plasma concentration of BAY1817080 after multiple doses (Cmax,md)
Area under the concentration-time curve of BAY1817080 after multiple dose (AUCτ,md)

Full Information

First Posted
February 10, 2020
Last Updated
January 24, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04265781
Brief Title
Study on the Safety of Drug BAY1817080 at Different Doses and the Way the Body Absorbs and Eliminates the Drug in Japanese Healthy Adult Male Participants
Official Title
Phase 1 Dose Escalation Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of BAY 1817080 in Japanese Healthy Adult Male Participants in a Single-center, Randomized, Single-blind, Placebo-controlled Design
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
September 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Researchers in this study want to learn about the safety of drug BAY1817080 at different doses and the resulting blood levels of the study drug in Japanese healthy adult male participants. Study drug BAY1817080 is a drug under development with a goal to suppress pain and chronic cough. It works by binding to and blocking proteins expressed on the sensory nerves of the womb tissue, bladder or airway which are oversensitive in the patients with endometriosis (a condition where the tissue that usually grows inside the womb grows outside of the womb), overactive bladder (a condition that causes a sudden urge to urinate often or more frequently) and long-standing cough with or without clear causes. Participants in this study will receive either the study drug or placebo tablets (a placebo looks like the test drug but does not have any medicine in it). The dosage will be either one single dose of study drug/placebo received on only one day or multiple doses of study drug/placebo received twice daily for 13 days plus one dose in the morning of the 14th day. The total study duration for each participant will be usually no more than 42 days. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough
Keywords
Refractory or unexplained chronic cough, Healthy volunteers, P2X3 receptor antagonist

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose escalation BAY1817080
Arm Type
Experimental
Arm Description
Participants receive dose 1 to 3 of BAY1817080 as a single dose on Day 1.
Arm Title
Dose expansion BAY1817080
Arm Type
Experimental
Arm Description
Participants receive the highest dose 3 of BAY1817080 twice daily (BID) from Day 1 until Day 13 and a single dose on Day 14.
Arm Title
Dose escalation Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo tablets orally as a single dose on Day 1.
Arm Title
Dose expansion Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo tablets as BID multiple doses from Day 1 until Day 13 and as a single dose on Day 14.
Intervention Type
Drug
Intervention Name(s)
BAY1817080
Intervention Description
Three different doses over the course of study
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Matching Placebo to BAY1817080
Primary Outcome Measure Information:
Title
Frequency of treatment-emergent adverse events (TEAE) after single dose of BAY1817080
Time Frame
Up to 14 days
Title
Severity of treatment-emergent adverse events after single dose of BAY1817080
Time Frame
Up to 14 days
Title
Frequency of treatment-emergent adverse events after multiple doses of BAY1817080
Time Frame
Up to 27 days
Title
Severity of treatment-emergent adverse events after multiple doses of BAY1817080
Time Frame
Up to 27 days
Secondary Outcome Measure Information:
Title
Maximum plasma concentration of BAY1817080 after single dose (Cmax)
Time Frame
At 0 hour before study drug administration and up to 15 hours after study drug administration at Day 1 and at 0 hours on Day 2 to Day 10
Title
Area under the concentration-time curve of BAY1817080 after single dose (AUC)
Description
In the case of extrapolated portion of AUC exceeding20% [%AUC(tlast-∞) >20%], the parameter AUC(0-tlast) may be evaluated as main parameter
Time Frame
At 0 hour before study drug administration and up to 15 hours after study drug administration at Day 1 and at 0 hours on Day 2 to Day 10
Title
Maximum plasma concentration of BAY1817080 after multiple doses (Cmax,md)
Time Frame
At 0 hours before drug administration and up to 12 hours after drug administration on Day 1, at 0 hours from Day 2 to Day 9 and from Day 11 to Day 12, at 0 and 12 hours on Day 13, at 0 hours until 15 hours on Day 14, and at 0 hours from Day 15 to Day 23
Title
Area under the concentration-time curve of BAY1817080 after multiple dose (AUCτ,md)
Time Frame
At 0 hours before drug administration and up to 12 hours after drug administration on Day 1, at 0 hours from Day 2 to Day 9 and from Day 11 to Day 12, at 0 and 12 hours on Day 13, at 0 hours until 15 hours on Day 14, and at 0 hours from Day 15 to Day 23

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant must be 20 to 45 years of age inclusive, at the time of signing the informed consent. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ECG. Non-smoker for at least 6 months and with a pack year history of equal to or less than 5 years Race: Japanese. BMI: above or equal 18.0 and below or equal 30.0 kg/m² at the screening visit. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the ICF and 90 days after the last administration of study intervention. 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 potentially interfering with the study objectives within the 4 weeks before screening or between screening and randomization Any febrile illness within the four weeks before screening or between screening and randomization Any known presence or history of severe allergies, non-allergic drug reactions, or multiple drug allergies Known or suspected malignant tumors or carcinoma in situ Any history of malignant tumors Any known or suspected benign tumors of the liver and/or pituitary gland Known liver disease: existing acute or chronic progressive liver disease, e.g. disturbance of bilirubin excretion (Dubin-Johnson and Rotor syndromes); disturbances of bile secretion and flow (cholestasis); presence or history of liver tumors (benign or malignant). Note: According to this criterion there must have been an interval of at least 6 months between the subsidence of any viral hepatitis (normalization of liver parameters) and the screening visit.
Facility Information:
Facility Name
Hakata Clinic
City
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no current plans to share data. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

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Study on the Safety of Drug BAY1817080 at Different Doses and the Way the Body Absorbs and Eliminates the Drug in Japanese Healthy Adult Male Participants

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