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
20
Interventional
18 Years - 60 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
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. |