HealthyPhase 1NCT02824315

Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants

A Phase 1 study testing AL-335, Odalasvir (ODV) and Simeprevir (SMV) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the steady-state pharmacokinetics (PK) of simeprevir (SMV), odalasvir (ODV) and AL-335 (and its metabolites ALS-022399 and ALS 022227), when these drugs are co-administered in healthy Japanese participants. Read more about this study

Who is it for?: Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: AL-335, Odalasvir (ODV) and Simeprevir (SMV)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited Kingdom
Study dates: May 2016to Oct 2016
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 20 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participant must be a Japanese participant who has resided outside Japan for no more than 5 years and whose parents and grandparents are Japanese as determined by participant's verbal report
Participant must have a body mass index (BMI: weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg
Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 milligram of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
Female participant must agree to not donate eggs (ova, oocytes) for the purpose of assisted reproduction during the study and for a period of 60 days after last study drug administration or until the last follow-up visit, whichever occurs later

Who cannot join

Participant has a history of liver or renal insufficiency (estimated creatinine clearance below 80 milliliters per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
Participant with a past history of heart arrhythmias (example- extra systolic beats or tachycardia at rest); risk factors associated with Torsade de Pointes such as hypokalemia or family history of short/long QT syndrome or sudden unexplained death (including sudden infant death syndrome) in a first degree relative [example- sibling, offspring, or biological parent])
Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
Participant has known allergies, hypersensitivity, or intolerance to simeprevir (SMV), odalasvir (ODV), AL-335 or their excipients
Participant is a woman who is pregnant, or breast-feeding, or planning to become pregnant from signing of Informed Consent Form (ICF) until 60 days after last study drug administration or until the last follow-up visit, whichever occurs later

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Study site
Surrey

Other trials in United Kingdom

About this study

Official title: A Phase 1, Open-label, Fixed Sequence Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Subjects

Conditions: Healthy
Being tested: AL-335, Odalasvir (ODV), Simeprevir (SMV)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AL-335Drug
AL--335 800 mg once daily on Days 1--3, 24--26 and 34--36.
Odalasvir (ODV)Drug
ODV 150 mg on Day 14 and 50 mg once daily on Days 15--23, 24--26, 27--33 and 34--36.
Simeprevir (SMV)Drug
Simeprevir 75 mg once daily on Days 4-13, 27--33 and 34--36.

Study groups in NCT02824315
Study group	Role	What they receive
AL-335+Simeprevir (SMV)+Odalasvir (ODV)	Experimental	Participants will receive AL-335 800 milligram (mg) once daily from day 1-3; SMV 75 mg once daily from Day 4-13; loading dose of ODV 150 mg on Day 14, followed by ODV 50 mg once daily from Day 15 to 23; ODV 50 mg once daily + AL-335 800 mg once daily from day 24-26; ODV 50 mg once daily + SMV 75 mg once daily from Day 27-33 and ODV 50 mg once daily + SMV 75 mg once daily + AL-335 800 mg once daily from Day 34 to 36. Receives: Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Analyte Concentration at Steady State (Cavg,ss)
The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).
Measured: Up to Day 36
Maximum Observed Analyte Concentration (Cmax)
The Cmax is the maximum observed analyte concentration.
Measured: Up to Day 36
Minimum Observed Analyte Concentration (Cmin)
The Cmin is the minimum observed analyte concentration during dosing interval.
Measured: Up to Day 36
Trough Plasma Concentration (Ctrough)
The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
Measured: Up to Day 36
Time to Reach Maximum Observed Analyte Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Up to Day 36
Area Under the Analyte Concentration-Time Curve From Time 0 to 24 Hours (AUC24)
The AUC24 is the area under the analyte concentration-time curve from time 0 to 24 hours.
Measured: Up to Day 36
Fluctuation Index (FI)
Fluctuation Index is defined as percentage of fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).
Measured: Up to Day 36
Area Under the Analyte Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast)
The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
Measured: Up to Day 36
Area Under the Analyte Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Measured: Up to Day 36
Elimination Rate Constant (Lambda[z])
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Measured: Up to Day 36
Elimination Half-Life (t1/2)
Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Measured: Up to Day 36

Secondary outcomes (1)

Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability
Measured: Up to Follow-up (170 to 175 days after last study drug intake)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016Oct 2016

First posted6 Jul 2016 (estimated)
Study startMay 2016
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02824315
Sponsor's protocol ID: CR108179
Other IDs: 64294178HPC1006, 2016-000950-36, 2016
Status last verified: Jan 2025
First submitted: 7 Jun 2016
Last updated: 3 Feb 2025
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

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, Fixed Sequence Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Subjects
ClinicalTrials.gov ID: NCT02824315
Acronym / sponsor ID: CR108179
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: May 2016
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 6 Jul 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AL-335+Simeprevir (SMV)+Odalasvir (ODV)	Experimental	Drug: AL-335, Drug: Odalasvir (ODV), Drug: Simeprevir (SMV)Participants will receive AL-335 800 milligram (mg) once daily from day 1-3; SMV 75 mg once daily from Day 4-13; loading dose of ODV 150 mg on Day 14, followed by ODV 50 mg once daily from Day 15 to 23; ODV 50 mg once daily + AL-335 800 mg once daily from day 24-26; ODV 50 mg once daily + SMV 75 mg once daily from Day 27-33 and ODV 50 mg once daily + SMV 75 mg once daily + AL-335 800 mg once daily from Day 34 to 36.

Who may qualify

Ages: 20 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participant must be a Japanese participant who has resided outside Japan for no more than 5 years and whose parents and grandparents are Japanese as determined by participant's verbal report
Participant must have a body mass index (BMI: weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg
Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 milligram of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
Female participant must agree to not donate eggs (ova, oocytes) for the purpose of assisted reproduction during the study and for a period of 60 days after last study drug administration or until the last follow-up visit, whichever occurs later

Key exclusion criteria (5 listed)

Participant has a history of liver or renal insufficiency (estimated creatinine clearance below 80 milliliters per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
Participant with a past history of heart arrhythmias (example- extra systolic beats or tachycardia at rest); risk factors associated with Torsade de Pointes such as hypokalemia or family history of short/long QT syndrome or sudden unexplained death (including sudden infant death syndrome) in a first degree relative [example- sibling, offspring, or biological parent])
Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
Participant has known allergies, hypersensitivity, or intolerance to simeprevir (SMV), odalasvir (ODV), AL-335 or their excipients
Participant is a woman who is pregnant, or breast-feeding, or planning to become pregnant from signing of Informed Consent Form (ICF) until 60 days after last study drug administration or until the last follow-up visit, whichever occurs later

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-335AL--335 800 mg once daily on Days 1--3, 24--26 and 34--36.	Drug	AL-335+Simeprevir (SMV)+Odalasvir (ODV)
Odalasvir (ODV)ODV 150 mg on Day 14 and 50 mg once daily on Days 15--23, 24--26, 27--33 and 34--36.	Drug	AL-335+Simeprevir (SMV)+Odalasvir (ODV)
Simeprevir (SMV)Simeprevir 75 mg once daily on Days 4-13, 27--33 and 34--36.	Drug	AL-335+Simeprevir (SMV)+Odalasvir (ODV)

Primary outcome

Average Analyte Concentration at Steady State (Cavg,ss)
Time frame: Up to Day 36
The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).
Maximum Observed Analyte Concentration (Cmax)
Time frame: Up to Day 36
The Cmax is the maximum observed analyte concentration.
Minimum Observed Analyte Concentration (Cmin)
Time frame: Up to Day 36
The Cmin is the minimum observed analyte concentration during dosing interval.
Trough Plasma Concentration (Ctrough)
Time frame: Up to Day 36
The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
Time to Reach Maximum Observed Analyte Concentration (Tmax)
Time frame: Up to Day 36
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Area Under the Analyte Concentration-Time Curve From Time 0 to 24 Hours (AUC24)
Time frame: Up to Day 36
The AUC24 is the area under the analyte concentration-time curve from time 0 to 24 hours.
Fluctuation Index (FI)
Time frame: Up to Day 36
Fluctuation Index is defined as percentage of fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).
Area Under the Analyte Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast)
Time frame: Up to Day 36
The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
Area Under the Analyte Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: Up to Day 36
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Elimination Rate Constant (Lambda[z])
Time frame: Up to Day 36
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Elimination Half-Life (t1/2)
Time frame: Up to Day 36
Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).

1 secondary outcome

Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability
Time frame: Up to Follow-up (170 to 175 days after last study drug intake)

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.

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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.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

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-335, Odalasvir (ODV) and Simeprevir (SMV) in people with Healthy, run by Janssen Research & Development, LLC 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 5 inclusion and 5 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?

Average Analyte Concentration at Steady State (Cavg,ss) (time frame: Up to Day 36). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02824315.

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.