Study to Collect Samples for MIST Analysis of Zibotentan and Bioavailability of Zibotentan and Dapagliflozin in Heatlhy Participants

Part of paid clinical trials in Brooklyn, Maryland.

Sponsor
AstraZeneca
Study ID
NCT04991571
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The study will have 2 independent parts: Part 1 of the study is intended to collect samples for Metabolites in Safety Testing (MIST) analysis after administration of multiple doses of zibotentan. Part 2 of the study is designed to evaluate the relative bioavailability of zibotentan and dapagliflozin after dosing with two different fixed-dose combination (FDC) formulations and dosing with separate formulations of zibotentan and dapagliflozin.

Key Dates

Start date
Jul 29, 2021
Status verified
Nov 2021
Primary completion
Oct 22, 2021
Completion
Oct 22, 2021

Study Design

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

Arms

  • Experimental: Part 1
    Participants will be administered with zibotentan once daily for 5 days.
  • Experimental: Part 2: Treatment Sequence ABC
    Each participant will receive 3 single-dose treatments of zibotentan and dapagliflozin (Treatment A; Treatment B; Treatment C) in 3 treatment periods, separated by a washout period of at least 7 days between treatment periods.
  • Experimental: Part 2: Treatment Sequence BCA
    Each participant will receive 3 single-dose treatments of zibotentan and dapagliflozin (Treatment B; Treatment C; Treatment A) in 3 treatment periods, separated by a washout period of at least 7 days between treatment periods.
  • Experimental: Part 2: Treatment Sequence CAB
    Each participant will receive 3 single-dose treatments of zibotentan and dapagliflozin (Treatment C; Treatment A; Treatment B) in 3 treatment periods, separated by a washout period of at least 7 days between treatment periods.

Primary Outcome Measure

Part 1: Metabolites in Safety Testing sampling [ Time Frame: Day 1 through Day 6 (pre-dose, 30 min; 1, 2, 4, 6, 8, 12 and 24 hours post dose) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteBrooklynMaryland21225-

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