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Completed

NCT Number: NCT04265781

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

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.

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Key information

Conditions

Endometriosis Related Pain Diabetic Neuropathic Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Pathological Conditions, Signs and Symptoms Refractory or Unexplained Chronic Cough Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Hakata Clinic

Fukuoka, 812-0025, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAY1817080

Drug

Three different doses over the course of study

Matching Placebo

Drug

Matching Placebo to BAY1817080

Primary outcomes

  1. Frequency of treatment-emergent adverse events (TEAE) after single dose of BAY1817080

    Time frame: Up to 14 days

  2. Severity of treatment-emergent adverse events after single dose of BAY1817080

    Time frame: Up to 14 days

  3. Frequency of treatment-emergent adverse events after multiple doses of BAY1817080

    Time frame: Up to 27 days

  4. Severity of treatment-emergent adverse events after multiple doses of BAY1817080

    Time frame: Up to 27 days

Secondary outcomes

  1. 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

  2. Area under the concentration-time curve of BAY1817080 after single dose (AUC)

    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

    In the case of extrapolated portion of AUC exceeding20% [%AUC(tlast-∞) >20%], the parameter AUC(0-tlast) may be evaluated as main parameter

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 12, 2020
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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