Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants
Condition: Anaemia
Intervention: Daprodustat
Intervention description: Daprodustat will be available as oral tablets.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 259.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Daprodustat; Pharmacokinetic; Bioequivalence; Bioavailability

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. Approximately 200 participants will be
      included in the study.
    

Eligibility 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.