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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2021-18-05
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
GSK Investigational Site
Las Vegas, Nevada, United States, 89113
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66212
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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