Trial · NCT04322253
Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Dug Given as a Single Oral Dose in Participants With Liver Impairment and Healthy Participants Matched for Age-, Gender-, and Weight
NCT04322253, Phase 1, Terminated, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Dug Given as a Single Oral Dose in Participants With Liver Impairment and Healthy Participants Matched for Age-, Gender-, and Weight. Trials, record NCT04322253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04322253
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Dug Given as a Single Oral Dose in Participants With Liver Impairment and Healthy Participants Matched for Age-, Gender-, and Weight
- NCT number
- NCT04322253
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 22 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Pharmacology, Clinical
- Interventions
- Neladenoson bialanate (BAY 1067197)
- First posted
- 2020-03-26
- Last updated
- 2020-03-26
- Other registries' IDs
- eudract:2017-000482-74
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | fu for BAY 84-3174 | At 4 hours after study drug administration | Fraction of free (unbound) drug in plasma or serum after single dose administration |
| Primary | AUC for BAY 84-3174 | Pre-dose up to 49 days after study drug administration | Area under the concentration vs. time curve from zero to infinity after single dose administration |
| Primary | AUCu for BAY 84-3174 | Pre-dose up to 49 days after study drug administration | AUC of unbound drug after single dose administration |
| Primary | AUCnorm for BAY 84-3174 | Pre-dose up to 49 days after study drug administration | AUC divided by dose per body weight after single dose administration |
| Primary | Cmax for BAY 84-3174 | Pre-dose up to 49 days after study drug administration | Maximum observed drug concentration in measured matrix after single dose administration |
| Primary | Cmax,u for BAY 84-3174 | Pre-dose up to 49 days after study drug administration | Cmax of unbound drug after single dose administration |
| Primary | Cmax,norm for BAY 84-3174 | Pre-dose up to 49 days after study drug administration | Cmax divided by dose per body weight after single dose administration |
| Secondary | Number of subjects with treatment-emergent adverse events (TEAEs) | Up to 49 days after study drug administration |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04322253
GET https://conductscience.org/api/trials/v1/NCT04322253/registered