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About
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.
Full 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.
Enrollment
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Inclusion criteria
Subject has a body mass index range of 18.5 to 30.0 kg/m2, inclusive and weighs at least 50 kg at screening.
A female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
Female subject must agree not to breastfeed starting at screening and throughout the study period and for 28 days after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period and for 28 days after the final study drug administration.
A male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 28 days after the final study drug administration.
A male subject must not donate sperm during the treatment period and for at least 28 days after the final study drug administration.
Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner(s) is (are) breastfeeding throughout the study period and for 28 days after the final study drug administration.
Subject agrees not to participate in another interventional study while participating in the present study.
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24 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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