NCT03239522 is a Phase 1 clinical trial of [14C]-GSK1278863 solution for IV infusion in Anaemia, sponsored by GlaxoSmithKline.

Who is sponsoring NCT03239522?

NCT03239522 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT03239522?

Interventions in NCT03239522: [14C]-GSK1278863 solution for IV infusion, [14C]-GSK1278863 oral solution, Daprodustat 6 mg oral tablet.

Is NCT03239522 still recruiting?

NCT03239522 is currently completed. Last updated 3 December 2019.

Are results published for NCT03239522?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-12-03 · How we verify

NCT03239522

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Absorption and Elimination of Radiolabeled Daprodustat

Completed Phase 1 Results posted Last updated 3 December 2019

What this trial tests

Phase 1 trial testing [14C]-GSK1278863 solution for IV infusion in Anaemia in 6 participants. Completed in 28 November 2017.

Timeline

10 October 2017

Primary endpoint
28 November 2017

28 November 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	10 October 2017
Primary completion	28 November 2017
Estimated completion	28 November 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

[14C]-GSK1278863 solution for IV infusion — full drug profile →
[14C]-GSK1278863 oral solution — full drug profile →
Daprodustat 6 mg oral tablet — full drug profile →

Conditions studied

Anaemia — all drugs for Anaemia →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 30 to 55, male only, with Anaemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-Inf]) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863 Primary · Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2

Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).

Group	Value	95% CI
[14C]-GSK1278863 50 µg IV Infusion	6.6864	± 19.8
[14C]-GSK1278863 25 mg Oral Solution	2278.8914	± 18.2

AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863 Primary · Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2

Group	Value	95% CI
[14C]-GSK1278863 50 µg IV Infusion	6.5252	± 18.9
[14C]-GSK1278863 25 mg Oral Solution	2206.7099	± 18.5

AUC (0-t) of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863 Primary · Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2

Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	824.6102	± 17.2

Maximum Observed Plasma Concentration (Cmax) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863 Primary · Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2

Group	Value	95% CI
[14C]-GSK1278863 50 µg IV Infusion	3.0114	± 15.8
[14C]-GSK1278863 25 mg Oral Solution	623.9059	± 34.8

Cmax of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863 Primary · Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	289.9998	± 30.7

Time of Occurrence of Cmax (Tmax) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863 Primary · Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2

Group	Value	95% CI
[14C]-GSK1278863 50 µg IV Infusion	0.9833	0.983 – 1.250
[14C]-GSK1278863 25 mg Oral Solution	0.7583	0.500 – 3.000

Tmax of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863 Primary · Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	1.0000	1.000 – 3.000

Apparent Terminal Phase Half-life (t1/2) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863 Primary · Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2

Group	Value	95% CI
[14C]-GSK1278863 50 µg IV Infusion	6.7699	± 106.4
[14C]-GSK1278863 25 mg Oral Solution	61.8251	± 15.1

Volume of Distribution at Steady State (Vss) of Total Drug-related Material (Radioactivity) in Plasma Following IV Dose of GSK1278863 Primary · Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1

Plasma samples were collected from participants at indicated time points in treatment period 1, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Group	Value	95% CI
[14C]-GSK1278863 50 µg IV Infusion	32.2355	± 59.1

Total Systemic Clearance (CL) of Total Drug-related Material (Radioactivity) in Plasma Following IV Dose of GSK1278863 Primary · Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1

Plasma samples were collected from participants at indicated time points in treatment period 1 after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Group	Value	95% CI
[14C]-GSK1278863 50 µg IV Infusion	7.4779	± 19.8

Percentage of the Total Radioactive Dose Excreted in Urine Over Time Following a Single, Oral Dose of [14C]-GSK1278863 Primary · Pre-dose and then over 24 hours collection periods as follows: 0-24, 24-48, 48-72, 72-96, 96-120,120-144 and 144-168 hours post-dose in treatment period 2

Urine samples were collected at the indicated time points to determine the rate and extent of excretion of total radioactivity in urine. All participants were asked to void their bladders before study treatment administration.

Pre-dose; n=6

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	0.000	± 0.0000

0-24 hours; n=6

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	20.450	± 2.7441

24-48 hours; n=6

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	20.838	± 2.8280

48-72 hours; n=6

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	21.003	± 2.8723

72-96 hours; n=6

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	21.065	± 2.8744

96-120 hours; n=6

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	21.065	± 2.8744

120-144 hours; n=6

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	21.065	± 2.8744

144-168 hours; n=5

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	21.434	± 3.0507

Percentage of the Total Radioactive Dose Excreted in Feces Over Time Following a Single, Oral Dose of [14C]-GSK1278863 Primary · Pre-dose and then over 24 hour collection periods as follows: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours post-dose in treatment period 2

Fecal samples were collected at the indicated time points to determine the rate and extent of excretion of total radioactivity in feces.

Pre-dose; n=6

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	0.000	± 0.0000

0-24 hours; n=5

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	0.096	± 0.1292

24-48 hours; n=5

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	22.298	± 31.0164

48-72 hours; n=6

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	49.988	± 25.3857

72-96 hours; n=6

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	68.312	± 6.0872

96-120 hours; n=5

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	73.450	± 3.1046

120-144 hours; n=5

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	74.698	± 2.1027

144-168 hours; n=4

Group	Value	95% CI
[14C]-GSK1278863 25 mg Oral Solution	73.553	± 3.6611

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 43 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion

Serious: 0/6 (0%)

Deaths: 0/6

[14C]-GSK1278863 25 mg Oral Solution

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (6 terms — click to expand)

Reaction	System	GSK1278863 6 mg Oral Table…	[14C]-GSK1278863 25 mg Ora…
Headache	Nervous system disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT03239522 adverse events section.

Sponsor's own description

Absorption, metabolism and excretion of daprodustat (GSK1278863) have been studied in previous clinical trials; however, the elimination routes and metabolic pathways of daprodustat have not been fully elucidated in humans. This is an open-label, single-center, non-randomized, 2-period, single-sequence, crossover, mass balance study in 6 healthy male participants. The aim of the study is to assess the excretion balance of daprodustat using \[14C\]-radiolabeled drug substance administered orally, and as an intravenous (IV) infusion, administered as a microtracer dose (concomitant with an oral, non-radiolabeled dose). Absolute bioavailability of an oral dose will also be assessed. Each participant will be involved in the study for up to 10 weeks which include a screening visit, two treatment periods (treatment periods 1 and 2), separated by about 7 days (at least 14 days between oral doses), and a follow up visit 1-2 weeks after the last assessment in treatment period 2. The primary objective of the study is to gain a better understanding of the compound's excretory and metabolic profile. This study will include sampling of duodenal bile to conduct qualitative assessment of drug metabolites in this matrix in order to characterize biliary elimination pathways.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Clinical Pharmacokinetics of Daprodustat: Results of an Absorption, Distribution, and Excretion Study With Intravenous Microtracer and Concomitant Oral Doses for Bioavailability Determination.
Mahar KM, Caltabiano S, Andrews S, Ramanjineyulu B, et al · · 2021 · cited 10× · PMID 34713596 · DOI 10.1002/cpdd.1029

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03239522 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 3 December 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03239522.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing