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
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.
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.
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Exclusion Criteria:
Medical and Surgical History
Electrocardiogram, blood pressure, pulse rate
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
Healthy male subjects will received corresponding placebo.
Drug: Placebo
Oral, tablet.
Oral, tablet.
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
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
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
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
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
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
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)
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.
Ran from Apr 2021 to primary completion in Jul 2021, 3 months.
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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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