HealthyPhase 1NCT02889367
A Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Single Dose Tablet Under Fed Conditions in Healthy Participants
A Phase 1 study testing Odalasvir 100 mg, Odalasvir 500 mg and Odalasvir (Up to maximum 1000 mg) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine the relationship between the plasma concentrations of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate) using exposure-response (ER) analysis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Odalasvir 100 mg, Odalasvir 500 mg and Odalasvir (Up to maximum 1000 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2016to 4 Mar 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Participant must be healthy on the basis of physical examination, medical history, and vital signs performed at screening
- Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
- Participant must have normal 12-lead electrocardiogram (ECG) and echocardiogram and must be healthy on the basis of clinical laboratory tests performed at screening
- Participant must be nonsmoker for at least 6 months prior to study drug administration
Who cannot join
- Participant with a history of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardia, and heart blocks
- Participant with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
- Participant with a past history of: Sick sinus syndrome, Cardiac arrhythmia (example, extrasystolic rhythms or tachycardia at rest). Isolated extrasystolic beats are not exclusionary, Risk factors associated with Torsade de Pointes (TdP) such as hypokalemia, Family history of short/long QT syndrome, Sudden unexplained death (including sudden infant death syndrome) in a first-degree relative (that is, sibling, offspring, or biological parent)
- Participant with any skin condition likely to interfere with ECG electrode placement or adhesion
- Participant with a breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues
- 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 received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days or within a period less than 10 times the drug's half-life, whichever is longer, before the planned administration of study drug, or is currently enrolled in an investigational study
- Participant has a history of human immunodeficiency virus (HIV)-1 or HIV-2 infection positive, or tests positive for HIV-1 or HIV-2 at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Tablet Formulation Under Fed Conditions in Healthy Subjects
The purpose of this study is to determine the relationship between the plasma concentrations of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate) using exposure-response (ER) analysis.
- Conditions
- Healthy
- Being tested
- Odalasvir 100 mg, Placebo, Odalasvir 500 mg, Odalasvir (Up to maximum 1000 mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Odalasvir 100 mgDrug
Participants will receive odalasvir 2*50 mg tablet, orally once on Day 1.
PlaceboDrug
Participants will receive odalasvir matching placebo, tablet, orally once on Day 1.
Odalasvir 500 mgDrug
Participants will receive odalasvir 10*50 mg tablet, orally once on Day 1.
Odalasvir (Up to maximum 1000 mg)Drug
Participants will receive odalasvir to be decided up to maximum of 20*50 mg tablet, orally once on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Participants will receive odalasvir 100 milligram (mg) or odalasvir matching placebo once on Day 1. Receives: Drug: Odalasvir 100 mg; Drug: Placebo |
| Treatment B | Experimental | Participants will receive odalasvir 500 mg or odalasvir matching placebo once on Day 1. Receives: Drug: Placebo; Drug: Odalasvir 500 mg |
| Treatment C | Experimental | Participants will receive odalasvir (dose to be determined based on pharmacokinetic data from treatment A and B but no more than 1000 mg) or odalasvir matching placebo once on Day 1. Receives: Drug: Placebo; Drug: Odalasvir (Up to maximum 1000 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Relationship Between the Plasma Concentrations of Odalasvir and Changes in the QT/QTc Interval Using Exposure-response (ER) Analysis
A linear mixed-effects model will assess the effect of dose and treatment on the change from baseline in QTc over time.
Measured: Baseline up to Day 4
Secondary outcomes (5)
Maximum Plasma Concentration (Cmax) of Odalasvir
Cmax is the maximum observed analyte concentration.
Measured: 0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Odalasvir
AUC(0-last) is the area under the plasma concentration-time curve from time zero to the last quantifiable time.
Measured: 0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Odalasvir
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(0-last) and C(last)/lambda(z); wherein AUC(0-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: 0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1
PR Interval Changes and the Relationship Between the Plasma Concentrations of Odalasvir and PR Interval Changes Using ER Analysis
A linear mixed-effects model will assess the effect of dose and treatment on the change from baseline in the PR interval over time.
Measured: Baseline up to Day 4
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: up to Day 65
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 start12 Sep 2016
- Primary completion4 Mar 2017
- Study completion4 Mar 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889367
- Sponsor's protocol ID
- CR108163
- Other IDs
- 64294178HPC1002
- Status last verified
- Apr 2017
- First submitted
- 31 Aug 2016
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Tablet Formulation Under Fed Conditions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02889367
- Acronym / sponsor ID
- CR108163
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 4 Mar 2017 (actual)
- Study completion
- 4 Mar 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.
The purpose of this study is to determine the relationship between the plasma concentrations of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate) using exposure-response (ER) analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Odalasvir 100 mg, Drug: PlaceboParticipants will receive odalasvir 100 milligram (mg) or odalasvir matching placebo once on Day 1. |
| Treatment B | Experimental | Drug: Placebo, Drug: Odalasvir 500 mgParticipants will receive odalasvir 500 mg or odalasvir matching placebo once on Day 1. |
| Treatment C | Experimental | Drug: Placebo, Drug: Odalasvir (Up to maximum 1000 mg)Participants will receive odalasvir (dose to be determined based on pharmacokinetic data from treatment A and B but no more than 1000 mg) or odalasvir matching placebo once on Day 1. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Participant must be healthy on the basis of physical examination, medical history, and vital signs performed at screening
- Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
- Participant must have normal 12-lead electrocardiogram (ECG) and echocardiogram and must be healthy on the basis of clinical laboratory tests performed at screening
Key exclusion criteria (8 listed)
- Participant with a history of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardia, and heart blocks
- Participant with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
- Participant with a past history of: Sick sinus syndrome, Cardiac arrhythmia (example, extrasystolic rhythms or tachycardia at rest). Isolated extrasystolic beats are not exclusionary, Risk factors associated with Torsade de Pointes (TdP) such as hypokalemia, Family history of short/long QT syndrome, Sudden unexplained death (including sudden infant death syndrome) in a first-degree relative (that is, sibling, offspring, or biological parent)
- Participant with any skin condition likely to interfere with ECG electrode placement or adhesion
- Participant with a breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues
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 100 mgParticipants will receive odalasvir 2*50 mg tablet, orally once on Day 1. | Drug | Treatment A |
| PlaceboParticipants will receive odalasvir matching placebo, tablet, orally once on Day 1. | Drug | Treatment A, Treatment B, Treatment C |
| Odalasvir 500 mgParticipants will receive odalasvir 10*50 mg tablet, orally once on Day 1. | Drug | Treatment B |
| Odalasvir (Up to maximum 1000 mg)Participants will receive odalasvir to be decided up to maximum of 20*50 mg tablet, orally once on Day 1. | Drug | Treatment C |
Primary outcome
The Relationship Between the Plasma Concentrations of Odalasvir and Changes in the QT/QTc Interval Using Exposure-response (ER) Analysis
Time frame: Baseline up to Day 4
A linear mixed-effects model will assess the effect of dose and treatment on the change from baseline in QTc over time.
5 secondary outcomes
Maximum Plasma Concentration (Cmax) of Odalasvir
Time frame: 0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Odalasvir
Time frame: 0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Odalasvir
Time frame: 0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1
PR Interval Changes and the Relationship Between the Plasma Concentrations of Odalasvir and PR Interval Changes Using ER Analysis
Time frame: Baseline up to Day 4
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: up to Day 65
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 10 Apr 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.
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 Odalasvir 100 mg, Odalasvir 500 mg and Odalasvir (Up to maximum 1000 mg) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
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 6 inclusion and 8 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 10 Apr 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 States. 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?
The Relationship Between the Plasma Concentrations of Odalasvir and Changes in the QT/QTc Interval Using Exposure-response (ER) Analysis (time frame: Baseline up to Day 4). 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 10 Apr 2017.