A Phase 1, Single-Center, Randomized, Open-Label, Single-Dose, Crossover Study to Assess the Pharmacokinetics, Including Food Effect, of AL-794 Formulations in Healthy Subjects

Alios Biopharma Inc.1 site in 1 country31 target enrollmentJune 30, 2016

ConditionsInfluenza

InterventionsAL-794 suspension AL-794 tablet

DrugsAL-794 suspension AL-794 tablet

Overview

Phase: Phase 1
Intervention: AL-794 suspension
Conditions: Influenza
Sponsor: Alios Biopharma Inc.
Enrollment: 31
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 30, 2016

End Date

May 31, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Alios Biopharma Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has provided written consent.
•In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned.
•Subject is in good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests and ECG.
•Male or female, 18-60 years of age.
•Body mass index (BMI) 18-30 kg/m2, inclusive. The minimum weight is 50 kg.
•A female subject is eligible to participate in this study if she is of non-childbearing potential or postmenopausal.
•If male, subject is surgically sterile or practicing acceptable forms of birth control until 90 days after the end of the study. Males must agree to refrain from sperm donation from check-in through 90 days after dosing.

Exclusion Criteria

•Men whose female partners are pregnant or contemplating pregnancy from the date of screening until 90 days after their last dose of study drugs.
•Clinically significant laboratory abnormalities or abnormalities which are deemed to interfere with the ability to interpret study data.
•Creatinine clearance of less than 60 mL/min (MDRD).
•Total bilirubin, ALT, AST, or Alkaline Phosphatase \>1.2×ULN (documented Gilbert's permitted).
•Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid or any other medical illness or psychiatric disorder, as determined by the Investigator and/or Sponsor's Medical Monitor.
•Positive screening test for influenza, hepatitis A, B, C or HIV serology.
•Any condition that, in the opinion of the investigator, would compromise the study's objectives or the well-being of the subject or prevent the subject from meeting the study requirements.
•Participation in an investigational drug trial or having received an investigational vaccine within 3 months or 5 half-lives (whichever is longer) prior to study medication.
•Clinically significant abnormal ECG findings. Particularly, a history or family history of prolonged QT syndrome (eg, torsade de pointes), pre-existing sinus node disease, (incomplete) AV block, heart failure, or sudden cardiac death; or a corrected QT interval (QTcF or QTcB) \>450 milliseconds for male subjects and \>470 milliseconds for female subjects at the screening visit.
•Clinically significant blood loss or elective blood donation of significant volume (ie, \>500 mL) within 90 days of first dose of study drug; \>1 unit of plasma within 7 days of first dose of study drug.

Arms & Interventions

Reference Formulation Fasted

150 mg of AL-794 study drug in suspension dosed in a fasted condition

Intervention: AL-794 suspension

Test Formulation Fasted

150 mg of AL-794 tablet formulation (3 x 50 mg tabs) dosed in a fasted condition

Intervention: AL-794 tablet

Test Formulation Fed

150 mg of AL-794 tablet formulation (3 x 50 mg tabs) dosed in a fed condition

Intervention: AL-794 tablet

Outcomes

Primary Outcomes

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

Secondary Outcomes

Safety as determined by AEs(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.(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)(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(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(From Day 1 (Prior to dosing) to Day 14)
Safety as determined by Physical examinations(From screening 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(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(From Day 1 (Prior to dosing) to Day 14)
Safety as determined by Clinical lab results(From screening to Day 14)
Safety as determined by 12-lead ECGs(From screening 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(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(From Day 1 (Prior to dosing) to Day 14)
Safety as determined by Vital signs(From screening 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.(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)(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(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(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(From Day 1 (Prior to dosing) to Day 14)