Study to Collect Samples for MIST Analysis of Zibotentan and Bioavailability of Zibotentan and Dapagliflozin in Heatlhy Participants
NCT ID: NCT04991571
Last Updated: 2021-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2021-07-29
2021-10-22
Brief Summary
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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.
Detailed Description
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Part 2 will be an open-label, randomised, 3-period, 3-treatment, cross-over single dose study. Participants will be randomised to one of 3 treatment sequences and will receive 3 single-dose study interventions. Participants will be resident at the study centre from 2 days before dosing (Day -2) until Day 3 of the last treatment sequence.
Participants who were enrolled in Part 1 may not be enrolled in Part 2.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Part 1
Participants will be administered with zibotentan once daily for 5 days.
Zibotentan (Treatment A)
Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2.
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.
Zibotentan (Treatment A)
Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2.
Dapagliflozin (Treatment A)
Dapagliflozin tablet will be administered orally as single dose in Part 2.
Zibotentan/Dapagliflozin - Formulation 1 (Treatment B)
Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
Zibotentan/Dapagliflozin - Formulation 2 (Treatment C)
Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
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.
Zibotentan (Treatment A)
Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2.
Dapagliflozin (Treatment A)
Dapagliflozin tablet will be administered orally as single dose in Part 2.
Zibotentan/Dapagliflozin - Formulation 1 (Treatment B)
Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
Zibotentan/Dapagliflozin - Formulation 2 (Treatment C)
Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
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.
Zibotentan (Treatment A)
Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2.
Dapagliflozin (Treatment A)
Dapagliflozin tablet will be administered orally as single dose in Part 2.
Zibotentan/Dapagliflozin - Formulation 1 (Treatment B)
Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
Zibotentan/Dapagliflozin - Formulation 2 (Treatment C)
Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
Interventions
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Zibotentan (Treatment A)
Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2.
Dapagliflozin (Treatment A)
Dapagliflozin tablet will be administered orally as single dose in Part 2.
Zibotentan/Dapagliflozin - Formulation 1 (Treatment B)
Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
Zibotentan/Dapagliflozin - Formulation 2 (Treatment C)
Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
Eligibility Criteria
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Inclusion Criteria
1. Participants with suitable veins for cannulation or repeated venipuncture.
2. Females must have a negative pregnancy test at the Screening Visit and within 24 hours prior to dosing, must not be lactating and must be of non- childbearing potential
3. Male participant must adhere to the contraception methods.
4. Have a BMI between 18 and 29.9 kg/m\^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
5. Provision of signed and dated, written informed consent prior to any study specific procedures.
Exclusion Criteria
2. Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention.
3. Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis.
4. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and Human immunodeficiency virus antibody.
5. Abnormal vital signs. 6 History of drug abuse or alcohol abuse.
7\. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
8\. Participants who are vegans or have medical dietary restrictions. 9. Participants tested positive for COVID-19 at the time of randomisation or have been previously hospitalised with COVID-19 infection.
18 Years
50 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Brooklyn, Maryland, United States
Countries
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Other Identifiers
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D4325C00003
Identifier Type: -
Identifier Source: org_study_id