Study identifier:D4326C00010
ClinicalTrials.gov identifier:NCT06715670
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Open-label, Single-dose, Four-period, Four-treatment, Cross-over Study to Assess the Pharmacokinetics of Zibotentan in Healthy Non-Asian and Japanese Participants
liver cirrhosis
Phase 1
Yes
Zibotentan
All
30
Interventional
18 Years - 60 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
PAREXEL
This study aim to assess the Pharmacokinetics of Zibotentan in Healthy Non-Asian and Japanese Participants.
This study will be Phase I, randomized, open-label, single-dose, 4-period, 4-treatment, cross-over study, performed at a single study center. The study will comprise: Screening Period of maximum 28 days; Four Treatment Periods, separated by 3 washout periods; Final Follow-up Visit within 5 to 7 days after the last study intervention administration. The washout periods will last at least 3 days, resulting in a total dosing-free time of at least 6 full days between each of the 4 treatments. Participant will receive the first dose is on Day 1, then the next dose will be on Day 8 at the earliest. Each participant will receive 4 different single doses (Dose 1, 2, 3 and 4) of zibotentan, at all 4 studied dose levels in one of the following treatment sequences: ABCD, BDAC, CADB, DCBA. Each participant will be involved in the study for approximately 9 weeks, depending upon the duration of the washout periods.
Location
Location
Glendale, CA, United States, 91206
Arms | Assigned Interventions |
---|---|
Experimental: Treatment sequence ABCD: Zibotentan Participants will receive single dose of Zibotentan in 4 occassions with first Treatment A, followed by Treatment B, Treatment C and then Treatment D with each dose separated by 3 washout periods. | Drug: Zibotentan Participant will receive 4 different single doses of zibotentan on Day 1 of each treatment period orally. |
Experimental: Treatment sequence BDAC: Zibotentan Participants will receive single dose of Zibotentan in 4 occassions with first Treatment B, followed by Treatment D, Treatment A and then Treatment C with each dose separated by 3 washout periods | Drug: Zibotentan Participant will receive 4 different single doses of zibotentan on Day 1 of each treatment period orally. |
Experimental: Treatment sequence CADB: Zibotentan Participants will receive single dose of Zibotentan in 4 occassions with first Treatment C, followed by Treatment A, Treatment D and then Treatment B with each dose separated by 3 washout periods. | Drug: Zibotentan Participant will receive 4 different single doses of zibotentan on Day 1 of each treatment period orally. |
Experimental: Treatment sequence DCBA: Zibotentan Participants will receive single dose of Zibotentan in 4 occassions with first Treatment D, followed by Treatment C, Treatment B and then Treatment A with each dose separated by 3 washout periods. | Drug: Zibotentan Participant will receive 4 different single doses of zibotentan on Day 1 of each treatment period orally. |
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