This study is a single-center, randomized, open-label crossover study to assess the pharmacokinetics and food effect of AL-794 formulations in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Hammersmith Medicines Research Ltd (HMR)
London, United Kingdom
Area under the concentration-time curve from time of dosing to infinity (AUC0-inf) of ALS-033719 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions.
Time frame: From Day 1 (Prior to dosing) to Day 14
Safety as determined by AEs
Time frame: From screening to Day 14
Safety as determined by Clinical lab results
Time frame: From screening to Day 14
Safety as determined by 12-lead ECGs
Time frame: From screening to Day 14
Safety as determined by Vital signs
Time frame: From screening to Day 14
Safety as determined by Physical examinations
Time frame: From screening to Day 14
Maximum observed concentration (Cmax) of ALS-033719 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions.
Time frame: From Day 1 (Prior to dosing) to Day 14
Area under the concentration-time curve from time of dosing to last quantifiable concentration (AUC0-last) of ALS-033719 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions.
Time frame: From Day 1 (Prior to dosing) to Day 14
PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: time of the maximum concentration (tmax)
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Time frame: From Day 1 (Prior to dosing) to Day 14
PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: terminal elimination half-life (t1/2)
Time frame: From Day 1 (Prior to dosing) to Day 14
PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: Cmax
Time frame: From Day 1 (Prior to dosing) to Day 14
PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: tmax
Time frame: From Day 1 (Prior to dosing) to Day 14
PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: t1/2
Time frame: From Day 1 (Prior to dosing) to Day 14
PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: AUC0-inf
Time frame: From Day 1 (Prior to dosing) to Day 14
PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: AUC0-last
Time frame: From Day 1 (Prior to dosing) to Day 14
PK parameters of ALS-033719 and ALS-033927 in plasma after a single oral dose of test formulation under fed conditions: Cmax
Time frame: From Day 1 (Prior to dosing) to Day 14
PK parameters of ALS-033719 and ALS-033927 in plasma after a single oral dose of test formulation under fed conditions: Tmax
Time frame: From Day 1 (Prior to dosing) to Day 14
PK parameters of ALS-033719 and ALS-033927 in plasma after a single oral dose of test formulation under fed conditions: AUC 0-inf
Time frame: From Day 1 (Prior to dosing) to Day 14
PK parameters of ALS-033719 and ALS-033927 in plasma after a single oral dose of test formulation under fed conditions: AUC 0-last
Time frame: From Day 1 (Prior to dosing) to Day 14