HealthyPhase 1NCT02821858

Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants

A Phase 1 study testing Odalasvir (ODV) and AL-335 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 pharmacokinetics (PK), safety and tolerability following single oral administration of ascending doses of odalasvir (ODV) in healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability following single oral administration of ascending doses… 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?: Odalasvir (ODV) and AL-335
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited Kingdom
Study dates: 14 Jun 2016to 30 Sep 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 kilogram (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 supine for 5 minutes) between 90 and 140 millimeter 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 (Panel 1) or 30 days (Panel 2) after 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 has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Participant with a past history of heart arrhythmias (for 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 [for 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 odalasvir (ODV) or AL-335 or its excipients

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, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Subjects

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

What participants receive

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

Odalasvir (ODV)Drug
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
AL-335Drug
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
PlaceboDrug
Matching placebo will be administered.

Study groups in NCT02821858
Study group	Role	What they receive
Panel 1: Treatment A	Experimental	Participants will receive odalasvir (ODV) 50 milligram (mg) (n=8) or placebo (n=2) on Day 1. Receives: Drug: Odalasvir (ODV); Drug: Placebo
Panel 1: Treatment B	Experimental	Participants will receive ODV 100 mg (n=8) or placebo (n=2) on Day 1. Receives: Drug: Odalasvir (ODV); Drug: Placebo
Panel 1: Treatment C	Experimental	Participants will receive ODV 300 mg (n=8) or placebo (n=2) on Day 1. Receives: Drug: Odalasvir (ODV); Drug: Placebo
Panel 2: Treatment D	Experimental	Participants will receive AL-335 400 mg (n=8) or placebo (n=2) on Day 1 of Period 1. Each treatment period will be separated by a washout period of 7 days. Receives: Drug: AL-335; Drug: Placebo
Panel 2: Treatment E	Experimental	Participants will receive AL-335 800 mg (n=8) or placebo (n=2) on Day 1 of Period 2. Each treatment period will be separated by a washout period of 7 days. Receives: Drug: AL-335; Drug: Placebo
Panel 2: Treatment F	Experimental	Participants will receive AL-335 1,200 mg (n=8) or placebo (n=2) on Day 1 of Period 3. Each treatment period will be separated by a washout period of 7 days. Receives: Drug: AL-335; Drug: Placebo

What is being measured

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

Maximum Observed Concentration (Cmax) of Odalasvir (ODV)
The Cmax is the maximum observed analyte concentration.
Measured: From Day 1 to Day 14 after intake of ODV
Time to Reach Maximum Observed Concentration (Tmax) of ODV
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: From Day 1 to Day 14 after intake of ODV
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of ODV
The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
Measured: From Day 1 to Day 50-55 after intake of ODV
Elimination Rate Constant (Lambda[z]) of ODV
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: From Day 1 to Day 50-55 after intake of ODV
Elimination Half-Life (t1/2) of ODV
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: From Day 1 to Day 50-55 after intake of ODV
Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ODV
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: From Day 1 to Day 50-55 after intake of ODV
Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for ODV
Measured: Up to 50-55 days after intake of ODV
Maximum Observed Concentration (Cmax) of AL-335
The Cmax is the maximum observed analyte concentration.
Measured: From Day 1 to Day 4 after intake of AL-335
Time to Reach Maximum Observed Concentration (Tmax) of AL-335
The Tmax is defined as actual sampling time to reach maximum observed concentration.
Measured: From Day 1 to Day 4 after intake of AL-335
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of AL-335
The (AUC [0-last]) is the area under the concentration-time curve from time 0 to time of the last quantifiable concentration.
Measured: From Day 1 to Day 4 after intake of AL-335
Elimination Rate Constant (Lambda[z]) of AL-335
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: From Day 1 to Day 4 after intake of AL-335
Elimination Half-Life (t1/2) of AL-335
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: From Day 1 to Day 4 after intake of AL-335
Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of AL-335
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: From Day 1 to Day 4 after intake of AL-335
Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for AL-335
Measured: Up to 30 to 35 days after last intake of AL-335

Timeline

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

14 Jun 201630 Sep 2016

First posted4 Jul 2016 (estimated)
Study start14 Jun 2016
Primary completion9 Sep 2016
Study completion30 Sep 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02821858
Sponsor's protocol ID: CR108178
Other IDs: 64294178HPC1005, 2015-005639-42, 2015
Status last verified: Mar 2018
First submitted: 10 Jun 2016
Last updated: 29 Mar 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Subjects
ClinicalTrials.gov ID: NCT02821858
Acronym / sponsor ID: CR108178
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 14 Jun 2016 (actual)
Primary completion: 9 Sep 2016 (actual)
Study completion: 30 Sep 2016 (actual)
First posted: 4 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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Panel 1: Treatment A	Experimental	Drug: Odalasvir (ODV), Drug: PlaceboParticipants will receive odalasvir (ODV) 50 milligram (mg) (n=8) or placebo (n=2) on Day 1.
Panel 1: Treatment B	Experimental	Drug: Odalasvir (ODV), Drug: PlaceboParticipants will receive ODV 100 mg (n=8) or placebo (n=2) on Day 1.
Panel 1: Treatment C	Experimental	Drug: Odalasvir (ODV), Drug: PlaceboParticipants will receive ODV 300 mg (n=8) or placebo (n=2) on Day 1.
Panel 2: Treatment D	Experimental	Drug: AL-335, Drug: PlaceboParticipants will receive AL-335 400 mg (n=8) or placebo (n=2) on Day 1 of Period 1. Each treatment period will be separated by a washout period of 7 days.
Panel 2: Treatment E	Experimental	Drug: AL-335, Drug: PlaceboParticipants will receive AL-335 800 mg (n=8) or placebo (n=2) on Day 1 of Period 2. Each treatment period will be separated by a washout period of 7 days.
Panel 2: Treatment F	Experimental	Drug: AL-335, Drug: PlaceboParticipants will receive AL-335 1,200 mg (n=8) or placebo (n=2) on Day 1 of Period 3. Each treatment period will be separated by a washout period of 7 days.

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 kilogram (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 supine for 5 minutes) between 90 and 140 millimeter 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 (Panel 1) or 30 days (Panel 2) after 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 has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Participant with a past history of heart arrhythmias (for 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 [for 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 odalasvir (ODV) or AL-335 or its excipients

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
Odalasvir (ODV)ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.	Drug	Panel 1: Treatment A, Panel 1: Treatment B, Panel 1: Treatment C
AL-335AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.	Drug	Panel 2: Treatment D, Panel 2: Treatment E, Panel 2: Treatment F
PlaceboMatching placebo will be administered.	Drug	Panel 1: Treatment A, Panel 1: Treatment B, Panel 1: Treatment C, Panel 2: Treatment D, Panel 2: Treatment E, Panel 2: Treatment F

Primary outcome

Maximum Observed Concentration (Cmax) of Odalasvir (ODV)
Time frame: From Day 1 to Day 14 after intake of ODV
The Cmax is the maximum observed analyte concentration.
Time to Reach Maximum Observed Concentration (Tmax) of ODV
Time frame: From Day 1 to Day 14 after intake of ODV
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of ODV
Time frame: From Day 1 to Day 50-55 after intake of ODV
The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
Elimination Rate Constant (Lambda[z]) of ODV
Time frame: From Day 1 to Day 50-55 after intake of ODV
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) of ODV
Time frame: From Day 1 to Day 50-55 after intake of ODV
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).
Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ODV
Time frame: From Day 1 to Day 50-55 after intake of ODV
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.
Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for ODV
Time frame: Up to 50-55 days after intake of ODV
Maximum Observed Concentration (Cmax) of AL-335
Time frame: From Day 1 to Day 4 after intake of AL-335
The Cmax is the maximum observed analyte concentration.
Time to Reach Maximum Observed Concentration (Tmax) of AL-335
Time frame: From Day 1 to Day 4 after intake of AL-335
The Tmax is defined as actual sampling time to reach maximum observed concentration.
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of AL-335
Time frame: From Day 1 to Day 4 after intake of AL-335
The (AUC [0-last]) is the area under the concentration-time curve from time 0 to time of the last quantifiable concentration.
Elimination Rate Constant (Lambda[z]) of AL-335
Time frame: From Day 1 to Day 4 after intake of AL-335
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) of AL-335
Time frame: From Day 1 to Day 4 after intake of AL-335
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).
Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of AL-335
Time frame: From Day 1 to Day 4 after intake of AL-335
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.
Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for AL-335
Time frame: Up to 30 to 35 days after last intake of AL-335

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 29 Mar 2018.

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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 and Developement, LLC Clinical Trial study director

Janssen Research and Developement, 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 Odalasvir (ODV) and AL-335 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 29 Mar 2018. 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 Concentration (Cmax) of Odalasvir (ODV) (time frame: From Day 1 to Day 14 after intake of ODV). The study lists 14 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 NCT02821858.

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 29 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.