Trial · NCT03223337
Daprodustat Hepatic Impairment Study
NCT03223337, Phase 1, Completed, GlaxoSmithKline; results first posted 2019-09-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Daprodustat Hepatic Impairment Study. Trials, record NCT03223337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03223337
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Daprodustat Hepatic Impairment Study
- NCT number
- NCT03223337
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 37 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- Daprodustat (GSK1278863)
- First posted
- 2017-07-21
- Last updated
- 2019-09-04
- Results first posted
- 2019-09-04
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), and GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population for whom a pharmacokinetic sample was obtained and analyzed. |
| Primary | Part 2: AUC (0-infinity) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2) , GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), and GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Primary | Part 1: Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), and GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Primary | Part 2: Percentage AUCex of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Primary | Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Primary | Part 2: AUC (0-t) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Primary | Part 1: Maximum Observed Concentration (Cmax) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Primary | Part 2: Cmax of GSK1278863 and Its Metabolites. | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), and GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Primary | Part 1: Apparent Terminal Phase Half-life (t1/2) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Primary | Part 2: T1/2 of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population | Hour*nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 2: AUC (0-infinity) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed. | Hour*nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population | Percentage of AUCex | MEAN |
| PRIMARY | Part 2: Percentage AUCex of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed. | Percentage of AUCex | MEAN |
| PRIMARY | Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population | Hour*nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 2: AUC (0-t) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed. | Hour*nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Maximum Observed Concentration (Cmax) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population | Nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 2: Cmax of GSK1278863 and Its Metabolites. | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed. | Nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Apparent Terminal Phase Half-life (t1/2) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population | Hours | GEOMETRIC_MEAN |
| PRIMARY | Part 2: T1/2 of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed. | Hours | GEOMETRIC_MEAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group540
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Part 1: Moderate Hepatic Impairment Participants | GSK1278863 | 296.2407 | Geometric Coefficient of Variation 111.1 | Hour*nanogram per milliliter |
| Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Part 1: Healthy Participants | GSK1278863 | 148.3225 | Geometric Coefficient of Variation 31.7 | Hour*nanogram per milliliter |
| Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Part 1: Moderate Hepatic Impairment Participants | GSK2391220 (M2) | 77.6352 | Geometric Coefficient of Variation 56.9 | Hour*nanogram per milliliter |
| Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Part 1: Healthy Participants | GSK2391220 (M2) | 47.1340 | Geometric Coefficient of Variation 30.9 | Hour*nanogram per milliliter |
| Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Part 1: Moderate Hepatic Impairment Participants | GSK2487818 (M4) | 47.5557 | Geometric Coefficient of Variation 67.4 | Hour*nanogram per milliliter |
| Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Part 1: Healthy Participants | GSK2487818 (M4) | 28.9896 | Geometric Coefficient of Variation 30.3 | Hour*nanogram per milliliter |
| Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Part 1: Moderate Hepatic Impairment Participants | GSK2506102 (M5) | 16.8212 | Geometric Coefficient of Variation 43.9 | Hour*nanogram per milliliter |
| Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Part 1: Healthy Participants | GSK2506102 (M5) | 11.2658 | Geometric Coefficient of Variation 29.4 | Hour*nanogram per milliliter |
| Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Part 1: Moderate Hepatic Impairment Participants | GSK2506104 (M3) | NA | Geometric Coefficient of Variation NA | Hour*nanogram per milliliter |
| Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Part 1: Healthy Participants | GSK2506104 (M3) | NA | Geometric Coefficient of Variation NA | Hour*nanogram per milliliter |
1 to 10 of 540Source ClinicalTrials.gov
See all 540 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 (Up to 16 Days) | STARTED | Part 1: Moderate Hepatic Impairment Participants | 8 | |
| Part 1 (Up to 16 Days) | STARTED | Part 1: Healthy Participants | 8 | |
| Part 1 (Up to 16 Days) | STARTED | Part 2: Mild Hepatic Impairment Participants | 0 | |
| Part 1 (Up to 16 Days) | STARTED | Part 2: Healthy Participants | 0 | |
| Part 1 (Up to 16 Days) | COMPLETED | Part 1: Moderate Hepatic Impairment Participants | 8 | |
| Part 1 (Up to 16 Days) | COMPLETED | Part 1: Healthy Participants | 8 | |
| Part 1 (Up to 16 Days) | COMPLETED | Part 2: Mild Hepatic Impairment Participants | 0 | |
| Part 1 (Up to 16 Days) | COMPLETED | Part 2: Healthy Participants | 0 | |
| Part 1 (Up to 16 Days) | NOT COMPLETED | Part 1: Moderate Hepatic Impairment Participants | 0 | |
| Part 1 (Up to 16 Days) | NOT COMPLETED | Part 1: Healthy Participants | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Toothache | Gastrointestinal disorders | Part 1: Moderate Hepatic Impairment Participants | 0 | 8 | |
| other | Toothache | Gastrointestinal disorders | Part 1: Healthy Participants | 1 | 8 | |
| other | Toothache | Gastrointestinal disorders | Part 2: Mild Hepatic Impairment Participants | 0 | 12 | |
| other | Toothache | Gastrointestinal disorders | Part 2: Healthy Participants | 0 | 9 | |
| other | Upper respiratory tract infection | Infections and infestations | Part 1: Moderate Hepatic Impairment Participants | 0 | 8 | |
| other | Upper respiratory tract infection | Infections and infestations | Part 1: Healthy Participants | 1 | 8 | |
| other | Upper respiratory tract infection | Infections and infestations | Part 2: Mild Hepatic Impairment Participants | 0 | 12 | |
| other | Upper respiratory tract infection | Infections and infestations | Part 2: Healthy Participants | 0 | 9 | |
| other | Skin abrasion | Injury, poisoning and procedural complications | Part 1: Moderate Hepatic Impairment Participants | 1 | 8 | |
| other | Skin abrasion | Injury, poisoning and procedural complications | Part 1: Healthy Participants | 0 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Moderate Hepatic Impairment Participants | 0 | 8 |
| Total, all-cause mortality | Part 1: Healthy Participants | 0 | 8 |
| Total, all-cause mortality | Part 2: Mild Hepatic Impairment Participants | 0 | 12 |
| Total, all-cause mortality | Part 2: Healthy Participants | 0 | 9 |
| Total, other adverse events | Part 1: Moderate Hepatic Impairment Participants | 1 | 8 |
| Total, other adverse events | Part 1: Healthy Participants | 2 | 8 |
| Total, other adverse events | Part 2: Mild Hepatic Impairment Participants | 0 | 12 |
| Total, other adverse events | Part 2: Healthy Participants | 0 | 9 |
| Total, serious adverse events | Part 1: Moderate Hepatic Impairment Participants | 0 | 8 |
| Total, serious adverse events | Part 1: Healthy Participants | 0 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35355447 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part 2: Mild Hepatic Impairment Participants vs Part 2: Healthy Participants: Part 2: Number of Participants With Abnormal Urinalysis Findings | Trial comparisons |
| Part 1: Moderate Hepatic Impairment Participants vs Part 1: Healthy Participants: Part 1: Number of Participants With Abnormal Urinalysis Findings | Trial comparisons |
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/NCT03223337
GET https://conductscience.org/api/trials/v1/NCT03223337/registered?page=2