This study will be conducted to evaluate the AZD5718 pharmacokinetic (PK) doses in order to determine exposure in a new dose range and compare with previous results. This study will include 14 subjects in a single site in United Kingdom. Each subject will be involved in the study for 6 to 7 weeks.
This study will be an open-label, randomized, 3-period, 3-treatment, crossover study performed in healthy subjects at a single study center. A total of 14 healthy male and female subjects (of no childbearing potential) will be randomized to ensure that at least 12 subjects are evaluable. Each subject will receive 3 different treatments at least 4 days apart and will be dosed following an overnight fast of at least 10 hours. The following treatments will be given: * Treatment A: AZD5718 Dose A tablet * Treatment B: AZD5718 Dose B tablet * Treatment C: AZD5718 Dose C tablet The study will comprise: * A Screening Period of maximum 28 days. * Three Treatment Periods during which subjects will be resident from the day before first dosing with AZD5718 (Day -1) in Treatment Period 1 until at least 48 hours after last dosing with AZD5718 in Treatment Period 3 for collection of PK and safety samples. Subjects will be discharged on Day 3 of Treatment Period 3. * A Follow up Visit, 5 to 7 days after the last dose of investigational medicinal product (IMP). There will be a minimum washout period of 4 days between each dose administration. Each subject will be involved in the study for 6 to 7 weeks. This study will be conducted in male and female subjects aged 18 to 55 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Subject will be given AZD5718 Dose A tablet once daily
Subjects will be given AZD5718 Dose B tablet once daily
Subjects will be given AZD5718 Dose C tablet once daily
Research Site
London, United Kingdom
Pharmacokinetic parameter: Area under plasma concentration time curve from zero to infinity (AUC)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Area under the plasma concentration curve from time zero to time of last quantifiable concentration (AUClast)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Maximum observed plasma concentration (Cmax)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Drug concentration 24 hours after dosing (C24)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t1/2λz)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Time to reach maximum observed plasma concentration (tmax)
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To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Number of subjects with advers event
Number of subjects with adverse event and/or abnormal vital signs or physical examination or laboratory assessments to further assess the safety of single doses of AZD5718 in healthy subjects.
Time frame: Upto 7 weeks
Pharmacokinetic parameter: AUC
To assess dose proportionality of AZD5718
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Cmax
To assess dose proportionality of AZD5718
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose