- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02877160
A Study to Assess the PK of AL-794 Formulations in Healthy Subjects
June 21, 2017 updated by: Alios Biopharma Inc.
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom
- Hammersmith Medicines Research Ltd (HMR)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
- 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.
- History of tobacco use or used nicotine-containing products within 3 months of the screening visit.
- The subject has a positive prestudy drug screen.
- The use of concomitant medications, including prescription, over the counter medications, herbal medications, inducers or inhibitors of CYP enzymes, glucuronidation or drug transporters (including P-glycoprotein and OATP1B1) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication is excluded, unless approved by the Sponsor's Medical Monitor. Occasional use of paracetamol, or its equivalent, is permitted.
- Exposure to more than 4 new investigational entities within 12 months prior to the first dosing day.
- Hypersensitivity to the active substances or to any of the excipients of AL-794, or prior dosing with AL-794.
- Unwillingness or inability to comply with the study protocol for any other reason.
- Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator or employees of Johnson & Johnson.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reference Formulation Fasted
150 mg of AL-794 study drug in suspension dosed in a fasted condition
|
|
Experimental: Test Formulation Fasted
150 mg of AL-794 tablet formulation (3 x 50 mg tabs) dosed in a fasted condition
|
|
Experimental: Test Formulation Fed
150 mg of AL-794 tablet formulation (3 x 50 mg tabs) dosed in a fed condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
From Day 1 (Prior to dosing) to Day 14
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety as determined by AEs
Time Frame: From screening to Day 14
|
From screening to Day 14
|
Safety as determined by Clinical lab results
Time Frame: From screening to Day 14
|
From screening to Day 14
|
Safety as determined by 12-lead ECGs
Time Frame: From screening to Day 14
|
From screening to Day 14
|
Safety as determined by Vital signs
Time Frame: From screening to Day 14
|
From screening to Day 14
|
Safety as determined by Physical examinations
Time Frame: From screening to Day 14
|
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
|
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
|
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)
Time Frame: From Day 1 (Prior to dosing) to Day 14
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
From Day 1 (Prior to dosing) to Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adeep Puri, HMR
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2016
Primary Completion (Actual)
February 28, 2017
Study Completion (Actual)
May 31, 2017
Study Registration Dates
First Submitted
July 11, 2016
First Submitted That Met QC Criteria
August 19, 2016
First Posted (Estimate)
August 24, 2016
Study Record Updates
Last Update Posted (Actual)
June 22, 2017
Last Update Submitted That Met QC Criteria
June 21, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- AL-794-803
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Influenza
-
Novartis VaccinesCompletedInfluenza | Seasonal Influenza | Human Influenza | Influenza Due to Unspecified Influenza VirusBelgium
-
Gamaleya Research Institute of Epidemiology and...CompletedInfluenza A | Influenza A Virus Infection | Influenza Epidemic | Influenza H5N1Russian Federation
-
Vanderbilt University Medical CenterHuman Vaccines ProjectCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Influenza Type B | Influenza A H3N2 | Influenza A H1N1United States
-
NPO PetrovaxCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Acute Respiratory Infection | Influenza Type B | Flu | Influenza A H3N2 | Influenza A H1N1 | Flu, Human | Influenza EpidemicRussian Federation
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza | Influenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH)CompletedInfluenza AUnited States
Clinical Trials on AL-794 suspension
-
Alios Biopharma Inc.Terminated
-
Alios Biopharma Inc.Completed
-
Alcon ResearchCompleted
-
Alcon ResearchCompleted
-
Alcon ResearchWithdrawn
-
Alcon ResearchWithdrawn
-
AmgenActive, not recruitingNon-squamous Non-small Cell Lung Cancer | Epithelial Ovarian Cancer | Claudin 6-positive Advanced/Metastatic Malignant Solid TumorsUnited States, Australia, Switzerland
-
Alcon ResearchCompletedOcular Hypertension | Open-Angle Glaucoma
-
Hospital General Universitario ElcheUnknown