Influenza in HumansPhase 1NCT02888327
A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872
A Phase 1 study testing AL-794, Oseltamivir and Digoxin in people with Influenza in Humans, run by Alios Biopharma Inc. at 1 site in United Kingdom.
Trial summary
This open-label, four group, fixed-sequence study will evaluate the safety and pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and probes for P-glycoprotein, CYP3A and OATP1B1 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza in Humans
- What is being tested?
- AL-794, Oseltamivir and Digoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2016to 30 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 electrocardiogram (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 (defined as females with a documented tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as 12 months of spontaneous amenorrhea and follicle stimulating hormone level within the laboratory's reference range for postmenopausal females). A postmenopausal female receiving hormone replacement therapy who is willing to discontinue hormone therapy 28 days before study drug dosing and agrees to remain off hormone replacement therapy for the duration of the study may be eligible for study participation. Females must refrain from donating eggs (ova, oocytes) for the purposes of assisted reproduction from check-in through 6 months after dosing.
- 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× upper limit of normal (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 human immunodeficiency virus (HIV) serology.
Show all 23Show fewer
- 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 or current diagnosis of sleep apnea.
- 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, oseltamivir, JNJ-63623872, digoxin, midazolam, or pitavastatin.
- 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, Open-label, Four Group, Fixed-Sequence Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir, JNJ-63623872, and Probes for P-glycoprotein, CYP3A and OATP1B1 in Healthy Volunteers
This open-label, four group, fixed-sequence study will evaluate the safety and pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and probes for P-glycoprotein, CYP3A and OATP1B1 in healthy volunteers.
Read the detailed description
This open-label, four group, fixed-sequence study will evaluate the safety and pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and probes for P-glycoprotein, CYP3A and OATP1B1 in healthy volunteers.
For each group, the study consists of an eligibility screening period, study period, and 1 follow-up visit. Groups may enroll in parallel but subjects enrolled in one group may not participate in another group.
- Conditions
- Influenza in Humans
- Being tested
- AL-794, Oseltamivir, Digoxin, Midazolam, Pitavastatin
- 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-794Drug
OseltamivirDrug
DigoxinDrug
MidazolamDrug
PitavastatinDrug
JNJ-63623872Drug
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir and AL-794 | Other | Oseltamivir alone and with AL-794 over fourteen days. Receives: Drug: AL-794; Drug: Oseltamivir |
| Digoxin, Midazolam, and AL-794 | Other | Single doses of Digoxin and Midazolam with and without AL-794 over seventeen days. Receives: Drug: AL-794; Drug: Digoxin; Drug: Midazolam |
| Pitavastatin and AL-794 | Other | Single doses of Pitavastatin with and without AL-794 over seventeen days. Receives: Drug: AL-794; Drug: Pitavastatin |
| JNJ-63623872 and AL-794 | Other | JNJ-63623872 alone and with AL-794 over fourteen days. Receives: Drug: AL-794; Drug: JNJ-63623872 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Measured: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872
Area under plasma concentration-time curve from time 0 to dosing interval (tau) (AUC0-τ) for ALS-033719 and ALS-033927, oseltamivir, oseltamivir carboxylate, and JNJ-63623872
Measured: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872
Area under plasma concentration-time curve from time 0 to last measurable plasma concentration (AUClast) for digoxin, midazolam 1'-OH-midazolam, and pitavastatin
Measured: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Maximum observed plasma concentration (Cmax) for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Measured: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Secondary outcomes (9)
Last observed plasma concentration (Clast) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Measured: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Terminal elimination half-life (t½) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Measured: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Time of the maximum observed plasma concentration (tmax) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Measured: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Time to last measurable plasma concentration (tlast) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Measured: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Apparent oral clearance (CL/F) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Measured: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Apparent volume of distribution (Vz/F) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Measured: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Apparent terminal elimination rate constant (λz) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Measured: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Number of participants with treatment emergent adverse events
Measured: From Day 1 to Day 29
Change from baseline in 4β-hydroxycholesterol (Group 3 only)
Measured: From Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start31 Jul 2016
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza in HumansStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alios Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adeep Puri, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888327
- Sponsor's protocol ID
- AL-794-802
- Status last verified
- Jan 2025
- First submitted
- 19 Aug 2016
- Last updated
- 3 Feb 2025
- 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 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-1, Open-label, Four Group, Fixed-Sequence Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir, JNJ-63623872, and Probes for P-glycoprotein, CYP3A and OATP1B1 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02888327
- Acronym / sponsor ID
- AL-794-802
- Conditions
- Influenza in Humans
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Alios Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 5 Sep 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 open-label, four group, fixed-sequence study will evaluate the safety and pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and probes for P-glycoprotein, CYP3A and OATP1B1 in healthy volunteers.
Detailed description
This open-label, four group, fixed-sequence study will evaluate the safety and pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and probes for P-glycoprotein, CYP3A and OATP1B1 in healthy volunteers.
For each group, the study consists of an eligibility screening period, study period, and 1 follow-up visit. Groups may enroll in parallel but subjects enrolled in one group may not participate in another group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir and AL-794 | Other | Drug: AL-794, Drug: OseltamivirOseltamivir alone and with AL-794 over fourteen days. |
| Digoxin, Midazolam, and AL-794 | Other | Drug: AL-794, Drug: Digoxin, Drug: MidazolamSingle doses of Digoxin and Midazolam with and without AL-794 over seventeen days. |
| Pitavastatin and AL-794 | Other | Drug: AL-794, Drug: PitavastatinSingle doses of Pitavastatin with and without AL-794 over seventeen days. |
| JNJ-63623872 and AL-794 | Other | Drug: AL-794, Drug: JNJ-63623872JNJ-63623872 alone and with AL-794 over fourteen days. |
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 electrocardiogram (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 (23 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× upper limit of normal (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 | Drug | Digoxin, Midazolam, and AL-794, JNJ-63623872 and AL-794, Oseltamivir and AL-794, Pitavastatin and AL-794 |
| Oseltamivir | Drug | Oseltamivir and AL-794 |
| Digoxin | Drug | Digoxin, Midazolam, and AL-794 |
| Midazolam | Drug | Digoxin, Midazolam, and AL-794 |
| Pitavastatin | Drug | Pitavastatin and AL-794 |
| JNJ-63623872 | Drug | JNJ-63623872 and AL-794 |
Primary outcome
Maximum observed plasma concentration (Cmax) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Time frame: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872
Area under plasma concentration-time curve from time 0 to dosing interval (tau) (AUC0-τ) for ALS-033719 and ALS-033927, oseltamivir, oseltamivir carboxylate, and JNJ-63623872
Time frame: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872
Area under plasma concentration-time curve from time 0 to last measurable plasma concentration (AUClast) for digoxin, midazolam 1'-OH-midazolam, and pitavastatin
Time frame: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Maximum observed plasma concentration (Cmax) for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Time frame: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
9 secondary outcomes
Last observed plasma concentration (Clast) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Time frame: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Terminal elimination half-life (t½) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Time frame: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Time of the maximum observed plasma concentration (tmax) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Time frame: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Time to last measurable plasma concentration (tlast) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Time frame: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Apparent oral clearance (CL/F) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Time frame: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Apparent volume of distribution (Vz/F) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Time frame: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Apparent terminal elimination rate constant (λz) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin when applicable
Time frame: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872, Days 1, 11, and 17 for oseltamivir, oseltamivir carboxylate, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin
Number of participants with treatment emergent adverse events
Time frame: From Day 1 to Day 29
Change from baseline in 4β-hydroxycholesterol (Group 3 only)
Time frame: From Day 1 to Day 29
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 3 Feb 2025.
Related trials for Influenza in Humans
Not yet recruitingPhase 2/3
Evaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza
Influenza, Human
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Not yet recruiting
Family Physician Nudges for Influenza Vaccination Among Older Adults
Influenza Vaccination
Recruiting
Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections
COVID-19 Respiratory Infection, Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
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
Hammersmith Medicines Research
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, Oseltamivir and Digoxin in people with Influenza in Humans, 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 23 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 3 Feb 2025. 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?
Maximum observed plasma concentration (Cmax) for ALS-033719, ALS-033927, oseltamivir, oseltamivir carboxylate, JNJ-63623872, digoxin, midazolam, 1'-OHmidazolam, and pitavastatin (time frame: At 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post dose on days 7, 8, and 14 for ALS-033719, ALS-033927, and JNJ-63623872). The study lists 4 primary outcomes in all. 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 3 Feb 2025.