A Study to Assess the PK of AL-794 Formulations in Healthy Subjects

NCT02877160 | Completed Phase 1

• 1 other identifier: AL-794-803
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• 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.

  From Day 1 (Prior to dosing) to Day 14

Secondary Outcomes (18)

• Safety as determined by AEs

  From screening 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

• Safety as determined by Vital signs

  From screening to Day 14

• Safety as determined by Physical examinations

  From screening to Day 14

Study Arms (3)

Reference Formulation Fasted

EXPERIMENTAL

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

Drug: AL-794 suspension

Test Formulation Fasted

EXPERIMENTAL

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

Drug: AL-794 tablet

Test Formulation Fed

EXPERIMENTAL

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

Drug: AL-794 tablet

Interventions

AL-794 suspension DRUG

Reference Formulation Fasted

AL-794 tablet DRUG

Test Formulation Fasted; Test Formulation Fed

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Clinically significant abnormal heart rate, respiratory rate, temperature or blood pressure values outside of the normal range, per local standards (evaluated in a semi-recumbent or recumbent position after 5 minutes of rest) which are considered clinically significant. One repeat measurement after an additional 5 minutes of rest is permitted in one visit day.
• Evidence of clinically significant infection within 2 weeks prior to admission.
• Unwilling to abstain from alcohol for at least 1 week prior to the start of dosing through the Study Completion visit.
• History of regular alcohol intake \>14 units per week of alcohol for females and \>21 units per week for males (one unit is defined as 8 g alcohol) within 3 months of the screening visit.
• History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 1 year before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening or Day 1.

Sponsors & Collaborators

• Alios Biopharma Inc.: lead

Study Sites (1)

Hammersmith Medicines Research Ltd (HMR)

London, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

sfericase

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Adeep Puri

  HMR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: August 24, 2016
• Study Start: June 30, 2016
• Primary Completion: February 28, 2017
• Study Completion: May 31, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

GB (1)