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CompletedNCT04802343Updated Oct 19, 2022

A Trial to Learn How BAY1817080 Moves Into, Through and Out of the Body and How Safe it is in Healthy Chinese Men

A Phase 1 interventional study of BAY1817080 and Placebo in Healthy Volunteers, sponsored by Bayer. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-19.

Sponsored by Bayer · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

Researchers are looking for a better way to treat chronic cough. Before patients with medical conditions can join clinical trials, researchers do trials in healthy participants first to understand how the body acts on the new treatment and learn how safe it is.

In this trial, the researchers will study how much of the trial drug, BAY1817080, gets into the blood in a small number of participants. The trial will include about 39 healthy Chinese male who are aged 18 to 45.

For this trial participants will be divided in 3 groups. Groups 1 and 2 will take either dose 1 or dose 2 of BAY1817080 or placebo 1 time. Participants of groups 3 will take dose 3 of BAY1817080 or placebo one time at the first day and continue to take dose 3 of BAY1817080 twice a day from day 7 to day 16 of the trial. On day 17 they will take only one dose 3 of BAY1817080.

All participants will take BAY1817080 or a placebo as a tablet by mouth. For this trial, the participants in Groups 1 and 2 will stay at the trial site for up to 10 days. The participants in Group 3 will stay at the trial site for up to 26 days. The trial will last up to 4 weeks for the participants in Groups 1 and 2, and 6 weeks for the participants in Group 3.

During the trial, the doctors will take blood and urine samples and check the participants blood pressure, pulse rate and electrocardiogram (ECG). The participants will answer questions about how they are feeling to check their general wellbeing.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Pharmacokinetics (PK)
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants who are overtly healthy according to complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-Lead electrocardiogram (ECG), and clinical laboratory tests
  • Race: Chinese
  • Age: 18 to 45 years (inclusive) of age
  • Weight: Body mass index (BMI): ≥ 18.0 and \<= 27.9 kg/m²
  • Male participants
  • Subjects who agree to use adequate contraception when sexually active during the study period and for 90 days after receiving the investigational medicinal product and not to act as sperm donor for 90 days after dosing.

Exclusion criteria

Exclusion Criteria:

Medical and Surgical History

  • 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
  • Medical history of hypogeusia/dysgeusia or dysfunction in the ability to taste
  • 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
  • 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.)
  • Any known relevant kidney disease (e.g. glomerulonephritis) or any renal injury associated with multisystem diseases/disorders (e.g. systemic lupus erythematosus, diabetic nephropathy)
  • Known metabolic disorders (e.g. diabetes mellitus, severe hypertriglyceridemia)
  • Known cardiovascular disorders requiring treatment
  • Migraine with neurological symptoms (complicated migraine)
  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
  • Known hypersensitivity to the study interventions including components of the preparation Medication, drug use and special behavioral patterns
  • Regular use of therapeutic or recreational drugs, e.g. carnitine products, anabolics, high-dose vitamins
  • Intake of drugs with a long half-life (>24 hours) within a timeframe of less than 5 half-lives before study drug administration
  • Use of any systemic or topically active drug(s) that might influence the results of the study within the 14 days before study intervention administration or during the study until follow-up. (Note: This includes drugs that might affect the PK of BAY 1817080, e.g. laxatives, loperamide, metoclopramide, antacids, H2-receptor antagonists, cytochrome P450 [CYP] 3A4 inducers, strong CYP3A4 inhibitors).

Electrocardiogram, blood pressure, pulse rate

  • Clinically relevant ECG findings, such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 msec at screening or pre-dose baseline measurement on Day -1 Physical examination
  • Clinically relevant findings in the physical examination Neurological examination
  • Clinically relevant findings in the orientating, basic neurological examination Laboratory examination
  • Positive result in urine drug screening, or positive alcohol breath test Other
  • Participation in another study and received an investigational drug within the 2 months or a longer and more appropriate time as determined by the investigator (e.g. approx. 5 half-lives of the previous investigational drug) before first study intervention administration
  • Criteria that in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    BAY1817080 dose escalation

    Healthy male subjects will receive BAY1817080 dose 1 and dose 2 as a single oral dose and BAY1817080 dose 3 as a single oral dose on Day 1 and twice daily (BID) from Day 7 to Day 16 followed by a last dose in the morning of Day 17.

    Drug: BAY1817080

  • Placebo comparator
    Placebo

    Healthy male subjects will received corresponding placebo.

    Drug: Placebo

Interventions

  • Oral, tablet.

  • DrugPlacebo

    Oral, tablet.

06

What researchers measure

Primary outcomes

  1. Cmax of BAY1817080 dose 1 and dose 2 (Day 1)

    Cmax: maximum observed drug concentration in measured matrix after single dose administration

    Time frame: Pre-dose on Day 1 to 216 hours post-dose

  2. Cmax of BAY1817080 dose 3 (Day 1)

    Cmax: maximum observed drug concentration in measured matrix after single dose administration

    Time frame: Pre-dose on Day 1 to 144 hours post-dose

  3. AUC of BAY1817080 dose 1 and dose 2 (Day 1)

    AUC: area under the concentration vs. time curve

    Time frame: Pre-dose on Day 1 to 216 hours post-dose

  4. AUC of BAY1817080 dose 3 (Day 1)

    AUC: area under the concentration vs. time curve

    Time frame: Pre-dose on Day 1 to 144 hours post-dose

  5. Cmax,md of BAY1817080 in dose 3 cohort (Day 17)

    Cmax,md: maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval, directly taken from analytical data

    Time frame: Pre-dose on Day 17 to 12 hours post-dose

  6. AUCτ,md of BAY1817080 in dose 3 cohort (Day 17)

    AUCτ,md: the area under the concentration-time curve in the dosing interval after multiple doses

    Time frame: Pre-dose on Day 17 to 12 hours post-dose

Secondary outcomes

  1. Number of participants with treatment emergent adverse events (TEAEs) with intensity

    Time frame: From the first dose of study intervention up to the follow-up visit (up to 30 days)

07

Study locations

1 site
  • Zhongshan Hospital, Fudan University
    Shanghai, 200032, China
08

References and documents

Publications

  • Li X, Haranaka M, Li H, Liu P, Chen H, Klein S, Reif S, Francke K, Friedrich C, Okumura K. P2X3 Receptor Antagonist Eliapixant in Phase I Clinical Trials: Safety and Inter-ethnic Comparison of Pharmacokinetics in Healthy Chinese and Japanese Participants. Clin Pharmacokinet. 2024 Jun;63(6):901-915. doi: 10.1007/s40262-024-01387-y. Epub 2024 Jun 21. PubMed 38907175 ↗

Individual participant data

Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2021 to primary completion in Jul 2021, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2021
First posted
Mar 17, 2021
StartActual
Apr 2, 2021
Primary completionActual
Jul 19, 2021
CompletionActual
Oct 29, 2021
Last update
Oct 19, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04802343
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Mar 17, 2021
Start date
Apr 2, 2021
Primary completion
Jul 19, 2021
Completion
Oct 29, 2021
Last update
Oct 19, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Eliapixant

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