AnaemiaPhase 1NCT04640311

Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants

A Phase 1 study testing Daprodustat in people with Anaemia, run by GlaxoSmithKline at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is comprised of two discrete Parts. Part A is a 3-period cross over evaluating relative bioavailability. Part B is a 2-period cross over evaluating bioequivalence. There will be a minimum of a 7-day washout period between treatment periods. Participants will participate in Part A or Part B, but not both. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Anaemia
What is being tested?: Daprodustat
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 259 participants
Where: 4 sitesUnited States
Study dates: 18 Dec 2020to 18 May 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
Participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator and/or the Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Participants with body weight more than or equal to (>=) 45 kilogram (kg) and body mass index (BMI) within the range 19-31 kg per meter square (Kg/m^2).
Male or female
A female participant is eligible to participate if she is not breastfeeding, and at least; not pregnant as confirmed by pregnancy testing or not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance during the treatment period to the follow-up visit.
Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Who cannot join

Participants with history of malignancy within the prior 2 years or currently receiving treatment for cancer. The only exception is localized squamous- or basal-cell carcinoma of the skin definitively treated 12 weeks or more prior to enrolment.
Participants unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with the study procedures or compromise participant safety.
Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 30 days prior to Day 1 in this study. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
Current enrolment or past participation (administration of last dose of investigational study treatment) within the last 30 days (or 5 half-lives, whichever is longer) before Day 1 in this study in any other clinical study involving an investigational study intervention or any other type of medical research.
Part A participants may not participate in Part B, and Part B participants may not participate in Part A if enrolment is concurrent or overlaps.
Participants with positive pre-study drug/alcohol screen.

Show all 11Show fewer

Participants with regular use of known drugs of abuse.
Participants with a positive laboratory confirmation of Coronavirus disease 2019 (COVID-19) infection, or high clinical index of suspicion for COVID-19.
Participants with regular alcohol consumption within 6 months prior to the study.
Participants with urinary cotinine levels indicative of smoking or history or regular use of tobacco or nicotine containing products (nicotine patches or vaporizing devices) within 6 months prior to screening.
Participants with sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Austin, Texas, 78744
GSK Investigational Site
Las Vegas, Nevada, 89113
GSK Investigational Site
Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Two-part, Randomized, Double-blind, Single-dose, Crossover Study to Compare Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Adult Volunteers

Conditions: Anaemia
Being tested: Daprodustat
Keywords: Daprodustat, Pharmacokinetic, Bioequivalence, Bioavailability
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DaprodustatDrug
Daprodustat will be available as oral tablets.

Study groups in NCT04640311
Study group	Role	What they receive
Part A: Daprodustat Dissolution 1/Dissolution 2/Reference	Experimental	Not described Receives: Drug: Daprodustat
Part A: Daprodustat Dissolution 2/Reference/Dissolution 1	Experimental	Not described Receives: Drug: Daprodustat
Part A: Daprodustat Reference/Dissolution 1/Dissolution 2	Experimental	Not described Receives: Drug: Daprodustat
Part B: Daprodustat Process 1/ Process 2	Experimental	Not described Receives: Drug: Daprodustat
Part B: Daprodustat Process 2/ Process 1	Experimental	Not described Receives: Drug: Daprodustat

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A: Area Under the Concentration-time Curve (AUC) From Zero (Pre-dose) to Time of Last Quantifiable Concentration (AUC[0-t]) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part B: AUC(0-t) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part A: Maximum Observed Plasma Concentration (Cmax) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part B: Cmax Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2

Secondary outcomes (10)

Part A: AUC From Zero Time (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part A: Time of Occurrence of Cmax (Tmax) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part A: Terminal Phase Half-life (T1/2) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part A: Apparent Clearance Following Oral Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part A: Apparent Volume of Distribution Following Oral Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part B: AUC(0-inf) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part B: Tmax Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part B: T1/2 Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part B: Apparent Clearance Following Oral Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part B: Apparent Volume of Distribution Following Oral Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 202018 May 2021

First posted23 Nov 2020
Study start18 Dec 2020
Primary completion18 May 2021
Study completion18 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AnaemiaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 259 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04640311
Sponsor's protocol ID: 213022
Status last verified: Apr 2025
First submitted: 18 Nov 2020
Last updated: 10 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Publications

Shaddinger B, Mahar KM, Sprys M, Andrews SM, Chattoraj S, Israni R, Cobitz A. Comparison of Two Manufacturing Processes of Daprodustat for Bioequivalence and Dissolution in Healthy Volunteers: A Randomized Crossover Study. Clin Pharmacol Drug Dev. 2023 Jul;12(7):739-748. doi: 10.1002/cpdd.1257. Epub 2023 May 1.
PubMed 37125459

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-part, Randomized, Double-blind, Single-dose, Crossover Study to Compare Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT04640311
Acronym / sponsor ID: 213022
Conditions: Anaemia
Keywords: Daprodustat, Pharmacokinetic, Bioequivalence, Bioavailability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 259 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 18 Dec 2020 (actual)
Primary completion: 18 May 2021 (actual)
Study completion: 18 May 2021 (actual)
First posted: 23 Nov 2020 (actual)
Results: Posted 26 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Part A: Daprodustat Dissolution 1/Dissolution 2/Reference	Experimental	Drug: Daprodustat
Part A: Daprodustat Dissolution 2/Reference/Dissolution 1	Experimental	Drug: Daprodustat
Part A: Daprodustat Reference/Dissolution 1/Dissolution 2	Experimental	Drug: Daprodustat
Part B: Daprodustat Process 1/ Process 2	Experimental	Drug: Daprodustat
Part B: Daprodustat Process 2/ Process 1	Experimental	Drug: Daprodustat

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
Participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator and/or the Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Participants with body weight more than or equal to (>=) 45 kilogram (kg) and body mass index (BMI) within the range 19-31 kg per meter square (Kg/m^2).
Male or female
A female participant is eligible to participate if she is not breastfeeding, and at least; not pregnant as confirmed by pregnancy testing or not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance during the treatment period to the follow-up visit.

Key exclusion criteria (11 listed)

Participants with history of malignancy within the prior 2 years or currently receiving treatment for cancer. The only exception is localized squamous- or basal-cell carcinoma of the skin definitively treated 12 weeks or more prior to enrolment.
Participants unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with the study procedures or compromise participant safety.
Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 30 days prior to Day 1 in this study. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
Current enrolment or past participation (administration of last dose of investigational study treatment) within the last 30 days (or 5 half-lives, whichever is longer) before Day 1 in this study in any other clinical study involving an investigational study intervention or any other type of medical research.
Part A participants may not participate in Part B, and Part B participants may not participate in Part A if enrolment is concurrent or overlaps.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DaprodustatDaprodustat will be available as oral tablets.	Drug	Part A: Daprodustat Dissolution 1/Dissolution 2/Reference, Part A: Daprodustat Dissolution 2/Reference/Dissolution 1, Part A: Daprodustat Reference/Dissolution 1/Dissolution 2, Part B: Daprodustat Process 1/ Process 2, Part B: Daprodustat Process 2/ Process 1

Primary outcome

Part A: Area Under the Concentration-time Curve (AUC) From Zero (Pre-dose) to Time of Last Quantifiable Concentration (AUC[0-t]) Following Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Part B: AUC(0-t) Following Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Part A: Maximum Observed Plasma Concentration (Cmax) Following Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Part B: Cmax Following Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.

10 secondary outcomes

Part A: AUC From Zero Time (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) Following Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part A: Time of Occurrence of Cmax (Tmax) Following Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part A: Terminal Phase Half-life (T1/2) Following Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part A: Apparent Clearance Following Oral Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part A: Apparent Volume of Distribution Following Oral Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part B: AUC(0-inf) Following Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part B: Tmax Following Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part B: T1/2 Following Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part B: Apparent Clearance Following Oral Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part B: Apparent Volume of Distribution Following Oral Administration of Daprodustat
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2

Results and safety

Results posted to the registry on 26 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Daprodustat DP 1 Process 2/Daprodustat DP 2 Process 2/Daprodustat Process 1	16	15
Part A: Daprodustat DP 2 Process 2/ Daprodustat Process 1 / Daprodustat DP 1 Process 2	18	16
Part A: Daprodustat Process 1 / Daprodustat DP 1 Process 2/ Daprodustat DP 2 Process 2	18	18
Part B: Daprodustat 1 mg Process 2/ Daprodustat 1 mg Process 1	0	0
Part B: Daprodustat 1 mg Process 1/Daprodustat 1 mg Process 2	0	0
Part B: Daprodustat 2 mg Process 2/Daprodustat 2 mg Process 1	0	0
Part B: Daprodustat 2 mg Process 1/ Daprodustat 2 mg Process 2	0	0
Part B: Daprodustat 4 mg Process 2/ Daprodustat 4 mg Process 1	0	0
Part B: Daprodustat 4 mg Process 1/Daprodustat 4 mg Process 2	0	0
Part B: Daprodustat 6 mg Process 2/Daprodustat 6 mg Process 1	0	0
Part B: Daprodustat 6 mg Process 1/Daprodustat 6 mg Process 2	0	0
Part B: Daprodustat 8 mg Process 2/Daprodustat 8 mg Process 1	0	0
Part B: Daprodustat 8 mg Process 1/Daprodustat 8 mg Process 2	0	0

Primary outcome: Part A: Area Under the Concentration-time Curve (AUC) From Zero (Pre-dose) to Time of Last Quantifiable Concentration (AUC[0-t]) Following Administration of Daprodustat

Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3. Geometric mean (Geometric Coefficient of Variation). Unit: Hours*nanograms per milliliter

Measure	Part A: Daprodustat Process 1 n = 35	Part A: Daprodustat Process 2 Dissolution Profile 1 n = 35	Part A: Daprodustat Process 2 Dissolution Profile 2 n = 34
Value	155.5 (14.7)	159.9 (14.7)	158.5 (14.7)

Part A: Daprodustat Process 1 vs Part A: Daprodustat Process 2 Dissolution Profile 1: Geometric mean ratio: 1.028 (90% CI 0.9699 to 1.090)
Part A: Daprodustat Process 1 vs Part A: Daprodustat Process 2 Dissolution Profile 2: Geometric mean ratio: 1.019 (90% CI 0.9602 to 1.081)

Population analysed: Pharmacokinetic Population comprised of all participants in the Safety Population (All randomized participants who have taken at least 1 dose of study intervention) who had at least 1 non-missing Pharmacokinetic assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).

Primary outcome: Part B: AUC(0-t) Following Administration of Daprodustat

Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2. Geometric mean (Geometric Coefficient of Variation). Unit: Hours*nanograms per milliliter

Measure	Part B: Daprodustat 1 mg Process 1 n = 39	Part B: Daprodustat 1 mg Process 2 n = 40	Part B: Daprodustat 2 mg Process 1 n = 42	Part B: Daprodustat 2 mg Process 2 n = 41	Part B: Daprodustat 4 mg Process 1 n = 42	Part B: Daprodustat 4 mg Process 2 n = 40	Part B: Daprodustat 6 mg Process 1 n = 42	Part B: Daprodustat 6 mg Process 2 n = 41	Part B: Daprodustat 8 mg Process 1 n = 40	Part B: Daprodustat 8 mg Process 2 n = 40
Value	36.97 (13.5)	38.02 (13.5)	83.27 (17.0)	79.08 (17.0)	132.9 (15.4)	134.2 (15.4)	249.5 (16.3)	241.5 (16.3)	292.8 (16.3)	278.5 (16.3)

Part B: Daprodustat 1 mg Process 1 vs Part B: Daprodustat 1 mg Process 2: Geometric mean ratio: 1.029 (90% CI 0.9770 to 1.083)
Part B: Daprodustat 2 mg Process 1 vs Part B: Daprodustat 2 mg Process 2: Geometric mean ratio: 0.9496 (90% CI 0.8914 to 1.012)
Part B: Daprodustat 4 mg Process 1 vs Part B: Daprodustat 4 mg Process 2: Geometric mean ratio: 1.010 (90% CI 0.9533 to 1.070)

Population analysed: Pharmacokinetic Population

Primary outcome: Part A: Maximum Observed Plasma Concentration (Cmax) Following Administration of Daprodustat

Measure	Part A: Daprodustat Process 1 n = 35	Part A: Daprodustat Process 2 Dissolution Profile 1 n = 35	Part A: Daprodustat Process 2 Dissolution Profile 2 n = 34
Value	68.22 (28.7)	71.06 (28.7)	71.51 (28.7)

Part A: Daprodustat Process 1 vs Part A: Daprodustat Process 2 Dissolution Profile 1: Geometric mean ratio: 1.042 (90% CI 0.9308 to 1.166)
Part A: Daprodustat Process 1 vs Part A: Daprodustat Process 2 Dissolution Profile 2: Geometric mean ratio: 1.048 (90% CI 0.9349 to 1.175)

Population analysed: Pharmacokinetic Population

Primary outcome: Part B: Cmax Following Administration of Daprodustat

Measure	Part B: Daprodustat 1 mg Process 1 n = 39	Part B: Daprodustat 1 mg Process 2 n = 40	Part B: Daprodustat 2 mg Process 1 n = 42	Part B: Daprodustat 2 mg Process 2 n = 41	Part B: Daprodustat 4 mg Process 1 n = 42	Part B: Daprodustat 4 mg Process 2 n = 40	Part B: Daprodustat 6 mg Process 1 n = 42	Part B: Daprodustat 6 mg Process 2 n = 41	Part B: Daprodustat 8 mg Process 1 n = 40	Part B: Daprodustat 8 mg Process 2 n = 40
Value	17.90 (22.2)	17.39 (22.2)	39.20 (28.8)	35.30 (28.8)	62.05 (30.9)	60.21 (30.9)	113.4 (26.7)	109.7 (26.7)	139.5 (27.6)	120.0 (27.6)

Part B: Daprodustat 1 mg Process 1 vs Part B: Daprodustat 1 mg Process 2: Geometric mean ratio: 0.9716 (90% CI 0.8936 to 1.056)
Part B: Daprodustat 2 mg Process 1 vs Part B: Daprodustat 2 mg Process 2: Geometric mean ratio: 0.9006 (90% CI 0.8107 to 1.000)
Part B: Daprodustat 4 mg Process 1 vs Part B: Daprodustat 4 mg Process 2: Geometric mean ratio: 0.9703 (90% CI 0.8665 to 1.087)

Population analysed: Pharmacokinetic Population

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Daprodustat Process 1	0 of 46 (0%)	2 of 46 (4.3%)	0 of 46
Part A: Daprodustat Process 2 Dissolution Profile 1	0 of 45 (0%)	3 of 45 (6.7%)	0 of 45
Part A: Daprodustat Process 2 Dissolution Profile 2	0 of 43 (0%)	0 of 43 (0%)	0 of 43
Part B: Daprodustat 1 mg Process 1	0 of 39 (0%)	1 of 39 (2.6%)	0 of 39
Part B: Daprodustat 1 mg Process 2	0 of 40 (0%)	1 of 40 (2.5%)	0 of 40
Part B: Daprodustat 2 mg Process 1	0 of 42 (0%)	3 of 42 (7.1%)	0 of 42
Part B: Daprodustat 2 mg Process 2	0 of 41 (0%)	1 of 41 (2.4%)	0 of 41
Part B: Daprodustat 4 mg Process 1	1 of 42 (2.4%)	3 of 42 (7.1%)	0 of 42
Part B: Daprodustat 4 mg Process 2	0 of 40 (0%)	5 of 40 (12.5%)	0 of 40
Part B: Daprodustat 6 mg Process 1	0 of 42 (0%)	6 of 42 (14.3%)	0 of 42
Part B: Daprodustat 6 mg Process 2	0 of 41 (0%)	1 of 41 (2.4%)	0 of 41
Part B: Daprodustat 8 mg Process 1	0 of 40 (0%)	5 of 40 (12.5%)	0 of 40
Part B: Daprodustat 8 mg Process 2	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37125459Shaddinger B, Mahar KM, Sprys M, Andrews SM, Chattoraj S, Israni R, Cobitz A. Comparison of Two Manufacturing Processes of Daprodustat for Bioequivalence and Dissolution in Healthy Volunteers: A Randomized Crossover Study. Clin Pharmacol Drug Dev. 2023 Jul;12(7):739-748. doi: 10.1002/cpdd.1257. Epub 2023 May 1.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Daprodustat in people with Anaemia, run by GlaxoSmithKline at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Area Under the Concentration-time Curve (AUC) From Zero (Pre-dose) to Time of Last Quantifiable Concentration (AUC[0-t]) Following Administration of Daprodustat (time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04640311, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.