Last updated: 04/02/2025 11:00:13

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

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GSK study ID
213022
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Clinicaltrials.gov ID
NCT04640311
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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. Approximately 200 participants will be included in the study.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Part A and Part B: Area Under Plasma Concentration-time Curve (AUC) From Zero Hours to Time of Last Quantifiable Concentration (AUC[0-t]) for daprodustat

Timeframe: Pre-dose and at 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose in each Period (Each period is 24 hours)

Part A and Part B: Maximum Plasma Concentration (Cmax) for daprodustat

Timeframe: Pre-dose and at 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose in each Period (Each period is 24 hours)

Secondary outcomes:

Part A and Part B: AUC From Time Zero to Infinity (AUC[0-inf]) for daprodustat

Timeframe: Pre-dose and at 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose in each Period (Each period is 24 hours)

Part A and Part B: Time of occurrence of Cmax (Tmax) for daprodustat

Timeframe: Pre-dose and at 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose in each Period (Each period is 24 hours)

Part A and Part B: Terminal Elimination Half-life (T1/2) for daprodustat

Timeframe: Pre-dose and at 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose in each Period (Each period is 24 hours)

Part A and Part B: Oral clearance (CL/F) for daprodustat

Timeframe: Pre-dose and at 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose in each Period (Each period is 24 hours)

Part A and Part B: Apparent Volume of Distribution (V/F) for daprodustat

Timeframe: Pre-dose and at 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose in each Period (Each period is 24 hours)

Interventions:
  • Drug: Daprodustat
    • Enrollment:
    259
    Primary completion date:
    2021-18-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bonnie S, Kelly M, Mike S, Susan A, Sayantan C, Rubeen I, et al. Comparison of Two Manufacturing Processes of Daprodustat for Bioequivalence and Dissolution in Healthy Volunteers: A Randomized Crossover Study. Clin Pharmacol Drug Dev. 2023-May-01; DOI:10.1002/cpdd.1257 PMID: 37125459
    Medical condition
    Anaemia
    Product
    daprodustat
    Collaborators
    Not applicable
    Study date(s)
    December 2020 to May 2021
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 Years
    Accepts healthy volunteers
    Yes
    • 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 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.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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.
    Exclusion criteria:
    • 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.
    • 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 location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89113
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Overland Park, Kansas, United States, 66212
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Austin, Texas, United States, 78744
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Anaheim, California, United States, 92801
    Status
    Study Complete
    Contact us

    Study documents

    Study report synopsis
    Available language(s): English
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    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2021-18-05
    Actual study completion date
    2021-18-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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