Renal InsufficiencyPhase 1NCT02894905
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335
A Phase 1 study testing AL-335 in people with Renal Insufficiency, run by Janssen Research & Development, LLC at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of AL-335 in participants with various degrees of impaired renal function (mild, moderate, and severe) compared to participants with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- AL-335
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Sep 2016to 16 Aug 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohorts 1-4:
- 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
- Participants must agree to follow all requirements that must be met during the study as noted in the Inclusion and Exclusion Criteria (eg, contraceptive requirements)
- Female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after study drug administration
- 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
- Cohorts 1-3:
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- Participant must have stable renal function
- Participant must be otherwise healthy except for the 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
- Participants must have an estimated glomerular filtration rate (eGFR) less than (<) 90 milliLiter per minute per 1.73 meter square (mL/min/1.73m^2). Mild renal impairment (eGFR 60 to <90 mL/min/1.73m^2); moderate renal impairment (eGFR 30 to <60 mL/min/1.73m^2); severe renal impairment (eGFR <30 mL/min/1.73m^2 not requiring dialysis)
- Cohort 4:
- Participant must be healthy on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening
- Participants must have an eGFR greater than or equal to (>=) 90 mL/min/1.73m^2
Who cannot join
- Cohorts 1-4:
- 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 (eg), 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.
- Cohorts 1-3:
- Participant requires dialysis
- Participant with imminent renal replacement therapy (ie, 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, Single-dose Study to Evaluate the Effect of Renal Impairment on the Single-dose Pharmacokinetics of AL-335
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of AL-335 in participants with various degrees of impaired renal function (mild, moderate, and severe) compared to participants with normal renal function.
- Conditions
- Renal Insufficiency
- Being tested
- AL-335
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-335Drug
Participants with various degrees of impaired renal function (mild [Cohort 1], moderate [Cohort 2], severe [Cohort 3]) and normal renal function (Cohort 4) will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets).
| Study group | Role | What they receive |
|---|---|---|
| AL-335 (Cohort 1) | Experimental | Participants with mild impaired renal function will receive a single oral dose of AL-335 800 milligram (mg) (given as 2*400-mg tablets). Receives: Drug: AL-335 |
| AL-335 (Cohort 2) | Experimental | Participants with moderate impaired renal function will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets). Receives: Drug: AL-335 |
| AL-335 (Cohort 3) | Experimental | Participants with severe impaired renal function will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets). Receives: Drug: AL-335 |
| AL-335 (Cohort 4) | Experimental | Participants with normal renal function will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets). Receives: Drug: AL-335 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax) of AL-335
The Cmax is the maximum observed concentration of analyte (AL-335).
Measured: Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
The AUClast is the area under the analyte (AL-335) concentration-time curve from time zero (0) to time of the last quantifiable concentration.
Measured: Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose
Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUCinfinity)
The AUCinfinity 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: Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose
Secondary outcomes (1)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: Up to follow-up (Approximately 30-35 days after study drug administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start13 Sep 2016
- Primary completion8 Aug 2017
- Study completion16 Aug 2017
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02894905
- Sponsor's protocol ID
- CR108225
- Other IDs
- 64294178HPC1009
- Status last verified
- Dec 2017
- First submitted
- 6 Sep 2016
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose Study to Evaluate the Effect of Renal Impairment on the Single-dose Pharmacokinetics of AL-335
- ClinicalTrials.gov ID
- NCT02894905
- Acronym / sponsor ID
- CR108225
- Conditions
- Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 9 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 evaluate the pharmacokinetics (PK) of a single oral dose of AL-335 in participants with various degrees of impaired renal function (mild, moderate, and severe) compared to participants with normal renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AL-335 (Cohort 1) | Experimental | Drug: AL-335Participants with mild impaired renal function will receive a single oral dose of AL-335 800 milligram (mg) (given as 2*400-mg tablets). |
| AL-335 (Cohort 2) | Experimental | Drug: AL-335Participants with moderate impaired renal function will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets). |
| AL-335 (Cohort 3) | Experimental | Drug: AL-335Participants with severe impaired renal function will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets). |
| AL-335 (Cohort 4) | Experimental | Drug: AL-335Participants with normal renal function will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not 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
- Participants must agree to follow all requirements that must be met during the study as noted in the Inclusion and Exclusion Criteria (eg, contraceptive requirements)
- Female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after study drug administration
- 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
- Participant must have stable renal function
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 (eg), 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 |
|---|---|---|
| AL-335Participants with various degrees of impaired renal function (mild [Cohort 1], moderate [Cohort 2], severe [Cohort 3]) and normal renal function (Cohort 4) will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets). | Drug | AL-335 (Cohort 1), AL-335 (Cohort 2), AL-335 (Cohort 3), AL-335 (Cohort 4) |
Primary outcome
Maximum Observed Concentration (Cmax) of AL-335
Time frame: Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose
The Cmax is the maximum observed concentration of analyte (AL-335).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose
The AUClast is the area under the analyte (AL-335) concentration-time curve from time zero (0) to time of the last quantifiable concentration.
Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUCinfinity)
Time frame: Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose
The AUCinfinity 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.
1 secondary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to follow-up (Approximately 30-35 days after study drug administration)
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 20 Dec 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
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 AL-335 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 20 Dec 2017. 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 Concentration (Cmax) of AL-335 (time frame: Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose). The study lists 3 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 20 Dec 2017.