A Study to Investigate the Blood Concentrations of 4 Different Oral Doses of Zibotentan in Healthy Non-Asian and Japanese Participants

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT06715670
Phase
PHASE1
Status
Completed

Conditions

  • Liver Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Zibotentan — DRUG
    Participant will receive 4 different single doses of zibotentan on Day 1 of each treatment period orally.

Study Details

This study aim to assess the Pharmacokinetics of Zibotentan in Healthy Non-Asian and Japanese Participants.

Key Dates

Start date
Dec 5, 2024
Status verified
Dec 2025
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.
  • 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
  • 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.
  • 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.

Primary Outcome Measure

Area under concentration-time curve from time 0 to infinity (AUCinf) [ Time Frame: Day 1 through Day 3 of each Treatment Period (each Treatment Period is 7 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-

Find similar trials in Glendale, CA

By research site
Research Site· Glendale, CA

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