Renal InsufficiencyPhase 1NCT02961660
A Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir
A Phase 1 study testing Odalasvir in people with Renal Insufficiency, run by Janssen Research & Development, LLC at 2 sites in United States.
Trial summary
The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in matched participants with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Odalasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2016to 9 Apr 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cohorts 1 and 2:
- Participant must have a body mass index (BMI; weight in kilogram (kg) divided by the square of height in meters) of 18 to 36 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
- Male Participant must agree not to donate sperm from enrollment (Day 1) in the study until at least 30 days after receiving the study drug
- Female Participant, except if postmenopausal, must have a negative serum (beta human chorionic gonadotropin [beta hCG]) pregnancy test at screening and negative highly sensitive urine pregnancy test at Day -1
- Cohort 1:
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- Participant must have severe renal impairment not requiring dialysis, defined as an estimated glomerular filtration rate (eGFR) less than (<) 30 milliLiter per minute (mL/min)/1.73 m^2
- Participant must have stable renal function that is no significant change in renal function as evidenced by the (mean) screening serum creatinine value within +/-25 percent (%) from the determination obtained at least 3 months prior to screening, and expected to remain stable during the study, and not be planning to initiate dialysis during the study period
- Participant must be otherwise healthy except for renal impairment and its underlying disease states and mild comorbidities and participant must be medically stable on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening. If there are abnormalities or results outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Cohort 2:
- Participant must be healthy on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening
- Participant must have an eGFR greater than or equal to (>=) 90 mL/min/1.73 m^2
Who cannot join
- Cohorts 1 and 2:
- Participant has a history of any illness (unrelated to renal impairment or its underlying disease, as appropriate) that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. This may include but is not limited to history of relevant drug or food allergies, history of cardiovascular or central nervous system disease, history or presence of clinically significant pathology, chronic skin disease, or history of mental disease
- Participant who is on a vegetarian diet or who takes creatine supplements, and who has a non-standard muscle mass, example amputation, malnutrition, muscle wasting, or extremely muscular (body building)
- Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening
- Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
- Participant who smokes more than 10 cigarettes or 2 cigars or 2 pipes per day from within 3 months before screening until the end of the study
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- Participant is a woman who is pregnant, or breast-feeding, or planning to become pregnant from signing of the informed consent form (ICF) onwards until 30 days after study drug administration
- Participant is a man who plans to father a child while enrolled in this study (Day 1) until 30 days after study drug administration
- Cohort 1:
- Participant requires dialysis
- Participant with imminent renal replacement therapy (that is, during the study period)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Knoxville, Tennessee
Study site
Orlando, Florida
About this study
Official title: An Open-label Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir
The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in matched participants with normal renal function.
- Conditions
- Renal Insufficiency
- Being tested
- Odalasvir
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OdalasvirDrug
Participants will receive odalasvir 25 mg tablet, orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Severe Renal Impairment): Odalasvir | Experimental | Participants will receive single oral dose of odalasvir 25 milligram (mg) under fed conditions (standard breakfast) on Day 1. Receives: Drug: Odalasvir |
| Cohort 2 (Normal Renal Function): Odalasvir | Experimental | Participants will receive single oral dose of odalasvir 25 milligram (mg) under fed conditions (standard breakfast) on Day 1. Receives: Drug: Odalasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Odalasvir
The Cmax is the maximum observed plasma analyte concentration.
Measured: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Odalasvir
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Odalasvir
The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
Measured: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours (AUC[0-72]) of Odalasvir
The AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours.
Measured: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Odalasvir
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Measured: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
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: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
Apparent Elimination Half-Life (t1/2) of Odalasvir
Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
Measured: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
Apparent Volume of Distribution (Vd/F) of Odalasvir
The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].
Measured: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
Total Apparent Oral Clearance (CL/F) of Odalasvir
The CL/F is defined as Dose/AUC (0-infinity).
Measured: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
Secondary outcomes (1)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: Baseline, up to follow-up (30 to 35 days after study drug intake)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start9 Nov 2016
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT02961660
- Sponsor's protocol ID
- CR108242
- Other IDs
- 64294178HPC1014
- Status last verified
- Jan 2025
- First submitted
- 9 Nov 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
- An Open-label Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir
- ClinicalTrials.gov ID
- NCT02961660
- Acronym / sponsor ID
- CR108242
- Conditions
- Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 11 Nov 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 main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in matched participants with normal renal function.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Severe Renal Impairment): Odalasvir | Experimental | Drug: OdalasvirParticipants will receive single oral dose of odalasvir 25 milligram (mg) under fed conditions (standard breakfast) on Day 1. |
| Cohort 2 (Normal Renal Function): Odalasvir | Experimental | Drug: OdalasvirParticipants will receive single oral dose of odalasvir 25 milligram (mg) under fed conditions (standard breakfast) on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participant must have a body mass index (BMI; weight in kilogram (kg) divided by the square of height in meters) of 18 to 36 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
- Male Participant must agree not to donate sperm from enrollment (Day 1) in the study until at least 30 days after receiving the study drug
- Female Participant, except if postmenopausal, must have a negative serum (beta human chorionic gonadotropin [beta hCG]) pregnancy test at screening and negative highly sensitive urine pregnancy test at Day -1
- Participant must have severe renal impairment not requiring dialysis, defined as an estimated glomerular filtration rate (eGFR) less than (<) 30 milliLiter per minute (mL/min)/1.73 m^2
Key exclusion criteria (11 listed)
- Participant has a history of any illness (unrelated to renal impairment or its underlying disease, as appropriate) that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. This may include but is not limited to history of relevant drug or food allergies, history of cardiovascular or central nervous system disease, history or presence of clinically significant pathology, chronic skin disease, or history of mental disease
- Participant who is on a vegetarian diet or who takes creatine supplements, and who has a non-standard muscle mass, example amputation, malnutrition, muscle wasting, or extremely muscular (body building)
- Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening
- Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
- Participant who smokes more than 10 cigarettes or 2 cigars or 2 pipes per day from within 3 months before screening until the end of the study
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 |
|---|---|---|
| OdalasvirParticipants will receive odalasvir 25 mg tablet, orally. | Drug | Cohort 1 (Severe Renal Impairment): Odalasvir, Cohort 2 (Normal Renal Function): Odalasvir |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Odalasvir
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The Cmax is the maximum observed plasma analyte concentration.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Odalasvir
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Odalasvir
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours (AUC[0-72]) of Odalasvir
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Odalasvir
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Odalasvir
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
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.
Apparent Elimination Half-Life (t1/2) of Odalasvir
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
Apparent Volume of Distribution (Vd/F) of Odalasvir
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].
Total Apparent Oral Clearance (CL/F) of Odalasvir
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The CL/F is defined as Dose/AUC (0-infinity).
1 secondary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Baseline, up to follow-up (30 to 35 days after 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
2 sites 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 in people with Renal Insufficiency, run by Janssen Research & Development, LLC at 2 sites 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 12 inclusion and 11 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 2 sites 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?
Maximum Observed Plasma Concentration (Cmax) of Odalasvir (time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose). The study lists 9 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.