The purpose of this study is to investigate the concentrations of zibotentan and dapagliflozin in blood when given with and without food in healthy participants.
This is a Phase I, open-label, randomized, 2-period, 2-treatment, crossover study in healthy participants. This study will measure the impact of food on the pharmacokinetics (PK) of combined zibotentan/dapagliflozin for the to be marketed fixed-dose combination (FDC) formulation (study intervention). The study will comprise of, (i) A screening period (ii) 2 treatment periods (iii) A final follow-up visit. All participants will receive a single dose of the study intervention once under fasted condition (Treatment A) and once under fed condition (Treatment B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Zibotentan/Dapagliflozin FDC will be administered as an oral tablet.
Research Site
Glendale, California, United States
Area under concentration-time curve from time 0 to infinity (AUCinf)
To investigate the effect of a high fat, high calorie meal, in comparison to fasting conditions, on the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To investigate the effect of a high fat, high calorie meal, in comparison to fasting conditions, on the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
Maximum observed drug concentration (Cmax)
To investigate the effect of a high fat, high calorie meal, in comparison to fasting conditions, on the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To further assess the safety and tolerability of single doses of zibotentan/dapagliflozin FDC in healthy participants.
Time frame: Up to end of study visit, for a total of approximately 5 weeks
Apparent total body clearance (CL/F)
To further evaluate the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
Apparent volume of distribution based on the terminal phase (Vz/F)
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To further evaluate the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
Time to reach maximum observed concentration (tmax)
To further evaluate the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
Terminal elimination half-life (t½λz)
To further evaluate the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods