Healthy VolunteersPhase 1NCT04802343
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 study testing BAY1817080 in people with Healthy Volunteers, run by Bayer at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BAY1817080
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2021to 29 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Placebo-controlled, Parallel-group, Double-blind Study to Investigate the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of BAY 1817080 in Chinese Healthy Adult Male Participants.
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.
Read more
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.
- Conditions
- Healthy Volunteers
- Being tested
- BAY1817080, Placebo
- Keywords
- Pharmacokinetics (PK)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1817080Drug
Oral, tablet.
PlaceboDrug
Oral, tablet.
| Study group | Role | What they receive |
|---|---|---|
| BAY1817080 dose escalation | Experimental | 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. Receives: Drug: BAY1817080 |
| Placebo | Placebo comparator | Healthy male subjects will received corresponding placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of BAY1817080 dose 1 and dose 2 (Day 1)
Cmax: maximum observed drug concentration in measured matrix after single dose administration
Measured: Pre-dose on Day 1 to 216 hours post-dose
Cmax of BAY1817080 dose 3 (Day 1)
Cmax: maximum observed drug concentration in measured matrix after single dose administration
Measured: Pre-dose on Day 1 to 144 hours post-dose
AUC of BAY1817080 dose 1 and dose 2 (Day 1)
AUC: area under the concentration vs. time curve
Measured: Pre-dose on Day 1 to 216 hours post-dose
AUC of BAY1817080 dose 3 (Day 1)
AUC: area under the concentration vs. time curve
Measured: Pre-dose on Day 1 to 144 hours post-dose
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
Measured: Pre-dose on Day 17 to 12 hours post-dose
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
Measured: Pre-dose on Day 17 to 12 hours post-dose
Secondary outcomes (1)
Number of participants with treatment emergent adverse events (TEAEs) with intensity
Measured: From the first dose of study intervention up to the follow-up visit (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start2 Apr 2021
- Primary completion19 Jul 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802343
- Sponsor's protocol ID
- 21009
- Status last verified
- Oct 2022
- First submitted
- 15 Mar 2021
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Placebo-controlled, Parallel-group, Double-blind Study to Investigate the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of BAY 1817080 in Chinese Healthy Adult Male Participants.
- ClinicalTrials.gov ID
- NCT04802343
- Acronym / sponsor ID
- 21009
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics (PK)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY1817080 dose escalation | Experimental | Drug: BAY1817080Healthy 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. |
| Placebo | Placebo comparator | Drug: PlaceboHealthy male subjects will received corresponding placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY1817080Oral, tablet. | Drug | BAY1817080 dose escalation |
| PlaceboOral, tablet. | Drug | Placebo |
Primary outcome
Cmax of BAY1817080 dose 1 and dose 2 (Day 1)
Time frame: Pre-dose on Day 1 to 216 hours post-dose
Cmax: maximum observed drug concentration in measured matrix after single dose administration
Cmax of BAY1817080 dose 3 (Day 1)
Time frame: Pre-dose on Day 1 to 144 hours post-dose
Cmax: maximum observed drug concentration in measured matrix after single dose administration
AUC of BAY1817080 dose 1 and dose 2 (Day 1)
Time frame: Pre-dose on Day 1 to 216 hours post-dose
AUC: area under the concentration vs. time curve
AUC of BAY1817080 dose 3 (Day 1)
Time frame: Pre-dose on Day 1 to 144 hours post-dose
AUC: area under the concentration vs. time curve
Cmax,md of BAY1817080 in dose 3 cohort (Day 17)
Time frame: Pre-dose on Day 17 to 12 hours post-dose
Cmax,md: maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval, directly taken from analytical data
AUCτ,md of BAY1817080 in dose 3 cohort (Day 17)
Time frame: Pre-dose on Day 17 to 12 hours post-dose
AUCτ,md: the area under the concentration-time curve in the dosing interval after multiple doses
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Derived from this study: PubMed 38907175Li 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY1817080 in people with Healthy Volunteers, run by Bayer at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of BAY1817080 dose 1 and dose 2 (Day 1) (time frame: Pre-dose on Day 1 to 216 hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04802343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.