A Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet Formulation and Pediatric Azo Dye-free Mini-tablet Formulation Compared to a Single Dose of Azo Dye-containing Tablet Formulation in Healthy Adult Subjects

Healthy Adult Subjects Clinical Trial

Official title:
A Phase 1 Crossover Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet and Pediatric Azo Dye-free Mini-tablet (Solid and Suspension) Compared to a Single Dose of Azo Dye-containing Tablet in Healthy Adult Subjects

Status Completed

Clinical Trial Summary

The purpose of the study is to assess the relative bioavailability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new formulations) compared to 100 mg roxadustat azo dye-containing tablet (reference formulation) under fasting conditions in healthy male and female adult participants.

This study will also evaluate the safety and tolerability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new formulations) and a single dose of 100 mg roxadustat azo dye-containing tablet (reference formulation) under fasting conditions in healthy male and female adult participants.

Clinical Trial Description

This is a 4-period, 4-sequence single dose crossover study. Each participant will participate in 4 treatment periods separated by a washout of at least 7 days between study drug administrations in each period. Participants will be randomized to 1 of 4 sequences.

Participants will be screened for up to 21 days prior to study drug administration on day 1 of period 1. Eligible participants will be admitted to the clinical unit on day -1 of each period and will be residential for 5 days/4 nights.

Participants will receive a single dose of 100 mg roxadustat pediatric azo dye-free tablet, 100 mg roxadustat pediatric azo dye-free mini-tablet (suspension), 100 mg roxadustat pediatric azo dye-free mini-tablet (solid) (new formulations) or 100 mg roxadustat azo dye-containing tablet (reference formulation) under fasting conditions on day 1 of each period. ;

Study Design

Related Conditions & MeSH terms

Healthy Adult Subjects

Clinical Trial Details

NCT number	NCT03960489
Study type	Interventional
Source	Astellas Pharma Inc
Contact
Status	Completed
Phase	Phase 1
Start date	July 31, 2019
Completion date	October 14, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.