A Phase 1 interventional study of BAY2395840 in Diabetic Neuropathic Pain, Renal Impairment and Healthy Volunteers, sponsored by Bayer. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Bayer · Phase 1, Interventional, and Basic science
Researchers are looking for a better way to treat people who have inflammatory conditions.
Inflammatory conditions may result from an increased activation of the body's natural defenses (the immune system) and are characterized by swelling, redness, heat, and pain.
The study treatment BAY2395840 is under development for use in inflammatory conditions. It works by blocking a protein, the B1 receptor, whose activation is involved in inflammatory responses.
The main purpose of this study is to learn how a single dose of BAY2395840 moves into, through and out of the body in participants with a moderate reduction of kidney function compared to matched participants with normal kidney function.
To answer this, the researchers will compare:
All participants will take a single dose of BAY2395840 as tablets. Each participant will be in the study for up to 5 weeks. They will stay in-house for 4 days, including one treatment day. In addition, one visit before and one visit after the in-house phase to the study site is planned.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
Browse Neuralgia studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Exclusion Criteria:
Participants with moderately impaired renal function will receive a single dose of BAY2395840.
Drug: BAY2395840
Participants with normal renal function matched to Group 1 will receive a single dose of BAY2395840.
Drug: BAY2395840
Participants with normal renal function aiming to balance out Group 2 for the age and gender investigations will receive a single dose of BAY2395840.
Drug: BAY2395840
Immediate release (IR) tablet, oral administration
Area under the concentration vs. time curve from zero to infinity (AUC) after single dose of BAY 2395840
AUC(0-tlast) will be used as the main parameter if AUC cannot be reliably determined
Time frame: From pre-dose up to 72 hours post administration
Maximum observed drug concentration in measured matrix (Cmax) after single dose of BAY 2395840
Time frame: From pre-dose up to 72 hours post administration
Unbound area under the concentration vs. time curve from zero to infinity (AUCu) after single (first) dose of BAY 2395840
AUC(0-tlast)u will be used as the main parameter if AUC cannot be reliably determined
Time frame: From pre-dose up to 72 hours post administration
Unbound maximum observed drug concentration in measured matrix (Cmax,u) after single dose of BAY 2395840
Time frame: From pre-dose up to 72 hours post administration
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From application of study intervention until follow-up Day 9
No study locations are listed for this record.
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.
This study is withdrawn, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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