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

NCT ID: NCT04640311

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 259 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-18
• Study Completion Date: 2021-05-18

Brief 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.

Conditions

Anaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A: Daprodustat Dissolution 1/Dissolution 2/Reference

Group Type: EXPERIMENTAL

Daprodustat

Intervention Type: DRUG

Daprodustat will be available as oral tablets.

Part A: Daprodustat Dissolution 2/Reference/Dissolution 1

Group Type: EXPERIMENTAL

Daprodustat

Intervention Type: DRUG

Daprodustat will be available as oral tablets.

Part A: Daprodustat Reference/Dissolution 1/Dissolution 2

Group Type: EXPERIMENTAL

Daprodustat

Intervention Type: DRUG

Daprodustat will be available as oral tablets.

Part B: Daprodustat Process 1/ Process 2

Group Type: EXPERIMENTAL

Daprodustat

Intervention Type: DRUG

Daprodustat will be available as oral tablets.

Part B: Daprodustat Process 2/ Process 1

Group Type: EXPERIMENTAL

Daprodustat

Intervention Type: DRUG

Daprodustat will be available as oral tablets.

Interventions

Daprodustat

Daprodustat will be available as oral tablets.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.

Exclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Overland Park, Kansas, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 37125459 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

213022

Identifier Type: -

Identifier Source: org_study_id