InfluenzaPhase 1NCT02877160
A Study to Assess the PK of AL-794 Formulations in Healthy Subjects
A Phase 1 study testing AL-794 suspension and AL-794 tablet in people with Influenza, run by Alios Biopharma Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- AL-794 suspension and AL-794 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2016to 31 May 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Influenza
- Being tested
- AL-794 suspension, AL-794 tablet
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-794 suspensionDrug
AL-794 tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| Reference Formulation Fasted | Experimental | 150 mg of AL-794 study drug in suspension dosed in a fasted condition Receives: 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 Receives: 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 Receives: Drug: AL-794 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 1 (Prior to dosing) to Day 14
Secondary outcomes (18)
Safety as determined by AEs
Measured: From screening to Day 14
Safety as determined by Clinical lab results
Measured: From screening to Day 14
Safety as determined by 12-lead ECGs
Measured: From screening to Day 14
Safety as determined by Vital signs
Measured: From screening to Day 14
Safety as determined by Physical examinations
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From Day 1 (Prior to dosing) to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start30 Jun 2016
- Primary completion28 Feb 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alios Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adeep Puri, Principal investigator, HMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877160
- Sponsor's protocol ID
- AL-794-803
- Status last verified
- Jun 2017
- First submitted
- 11 Jul 2016
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02877160
- Acronym / sponsor ID
- AL-794-803
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Alios Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference Formulation Fasted | Experimental | Drug: AL-794 suspension150 mg of AL-794 study drug in suspension dosed in a fasted condition |
| Test Formulation Fasted | Experimental | Drug: AL-794 tablet150 mg of AL-794 tablet formulation (3 x 50 mg tabs) dosed in a fasted condition |
| Test Formulation Fed | Experimental | Drug: AL-794 tablet150 mg of AL-794 tablet formulation (3 x 50 mg tabs) dosed in a fed condition |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL-794 suspension | Drug | Reference Formulation Fasted |
| AL-794 tablet | Drug | Test Formulation Fasted, Test Formulation Fed |
Primary outcome
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
18 secondary outcomes
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeep Puri principal investigator
HMR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AL-794 suspension and AL-794 tablet in people with Influenza, run by Alios Biopharma Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.