Chronic Kidney Disease
Conditions
Keywords
AZD5718, Bioavailability, 5-lipoxygenase activating protein (FLAP) inhibitor, Safety and tolerability
Brief summary
This study will be a randomised, open-label, 3-period, 3-treatment, single-dose, crossover study in healthy subjects The study will be performed at a single study centre in the United Kingdom.
Detailed description
The study will comprise: * A screening period of maximum 28 days; * 3 treatment periods during which subjects will be resident at the Clinical Unit from the day before dosing with AZD5718 (Day -1) until at least 48 hours after dosing (Day 3), with discharge on the morning of Day 3 of each treatment period; and * A final visit within 5 to 7 days after the last administration of AZD5718. Subjects will receive single doses of AZD5718 on 3 occasions, separated by at least 7 days washout, under fasted and fed conditions. Two different formulations (Test Formulation and Reference Formulation) will be given in a randomised order: * Treatment A (Test Formulation): AZD5718 Dose A, fasted * Treatment B (Test Formulation): AZD5718 Dose A, fed * Treatment C (Reference Formulation): AZD5718 Dose A, fasted
Interventions
DRUGAZD5718
Subjects will receive single doses of AZD5718 on 3 occasions, separated by at least 7 days washout, under fasted and fed conditions.
Sponsors
Parexel
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Only key inclusion and
Exclusion criteria
are presented here: Inclusion Criteria: * Healthy male and/or female subjects aged 18 - 55 years inclusive with suitable veins for cannulation or repeated venipuncture. * Females must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at each admission to the unit, must not be lactating and must be of nonchildbearing potential, confirmed at the Screening Visit. * Male subjects must adhere to the contraception methods as detailed in protocol. * Have a body mass index between 18.5 and 30 kg/m\^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under plasma concentration-time curve from zero to infinity (AUCinf) (Treatment A versus Treatment C) | Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours) | Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using AUCinf will be assessed. |
| Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast) (Treatment A versus Treatment C) | Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours) | Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using AUClast will be assessed. |
| Maximum observed plasma (peak) drug concentration (Cmax) (Treatment A versus Treatment C) | Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours) | Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using Cmax will be assessed. |
| Plasma concentration at 24h post-dose (C24) (Treatment A versus Treatment C) | Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours) | Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using C24 will be assessed. |
| AUCinf (Treatment B versus Treatment A) | Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours) | Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using AUCinf will be assessed. |
| AUClast (Treatment B versus Treatment A) | Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours) | Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using AUClast will be assessed. |
| C24 (Treatment B versus Treatment A) | Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours) | Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using C24 will be assessed. |
| Cmax (Treatment B versus Treatment A) | Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours) | Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using Cmax will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events (AEs) and serious AEs | From screening (SAEs only) until Follow-up Visit (5 to 7 days post final dose) | Safety and tolerability of single doses of AZD5718 in healthy subjects will be assessed. |
Countries
United Kingdom
Outcome results
None listed