Chronic Kidney Disease Clinical Trial
Official title:
A Phase I Randomized Double-blind Placebo-controlled Study With 2 Separate Cohorts to Assess the Safety, Tolerability and Pharmacokinetics of Verinurad and Allopurinol in Healthy Asian and Chinese Subjects
This is a randomized, placebo controlled, double-blind study with two separate cohorts to
assess safety, tolerability and pharmacokinetics of verinurad and allopurinol in healthy
subjects.
In cohort 1, twelve Asian subjects will be treated with allopurinol 300mg for 7 days followed
by either allopurinol 300mg and verinurad 24mg or matching placebo for 7 days.
In Cohort 2, nine Chinese subjects will be treated with allopurinol 300mg for 7 days followed
by allopurinol 300mg and verinurad 12mg administered on 7 out of 8 days.
This is a Phase I study with 2 parallel cohorts which will be performed at a single study
center.
Cohort-1 will comprise of 12 healthy Asian participants, and will follow a randomized,
double-blind, placebo-controlled design. The number of Chinese participants included in
Cohort 1 must be less than 50% of the total number of participants enrolled into the cohort.
Nine participants will be randomized to receive 24 mg verinurad and 300 mg allopurinol once
daily for 7 days and 3 participants will be randomized to receive matching placebos once
daily for 7 days. Cohort 1 participants will undergo a Screening Period of a maximum of 28
days followed by a 7-day Run-in Period during which participants will receive 300 mg
allopurinol or matching placebo once daily. Participants will then be randomized before the
start of the Run-in Period. The Run-in Period is intended to decrease the risk of skin
toxicity of allopurinol. Participants will be admitted to the clinical unit 2-days before the
treatment period, during which they will receive once daily doses of 24 mg verinurad and 300
mg allopurinol or matching placebos. Participants will be discharged from the clinical unit
on Day 8, but will return for a Follow-up Visit within 7 to 14 days.
Cohort-2 will comprise of 9 healthy Chinese participants and will follow an open-label
design. All 9 Chinese participants will receive 12 mg verinurad and 300 mg allopurinol on Day
1 and Day 3 to Day 9. For Cohort-2, participants will undergo a Screening Period of a maximum
of 28 days followed by a 7-day Run-in Period during which participants will receive 300 mg
allopurinol once daily. Participants will be admitted to the Clinical Unit on Day -2, and
will receive a single dose of 12 mg verinurad and 300 mg allopurinol on Day 1. No dosing will
be done on Day 2. Participants will continue dosing on Day 3 and will be dosed once daily
until Day 9. Participants will be discharged from the Clinical Unit on Day 10, but will
return for a Follow-up Visit within 7 to 14 days.
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