Renal ImpairmentPhase 1NCT01526746
Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment and Matched Control Subjects With Relatively Normal Renal Function
A Phase 1 study testing Tasimelteon in people with Renal Impairment, run by Vanda Pharmaceuticals at 3 sites in United States.
Trial summary
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood of individuals with severe renal impairment compared to individuals who have normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Tasimelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2012to Jun 2012
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Groups 1-3
- Ability and acceptance to provide written informed consent;
- Men or women between 18 - 79 years, inclusive;
- Subjects with Body Mass Index (BMI) of >18 and <40 kg/m2 (BMI = weight (kg)/ [height (m)]2);
- Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 6 months before screening), or females of child-bearing potential using an acceptable method of birth control for a period of 35 days before the first dosing and have a negative pregnancy test at the screening and baseline visits; Note 1: Acceptable methods of birth control include any one of the following: abstinence, vasectomized sexual partner, hormonal methods (i.e. pill, hormonal IUD, Depo-Provera, implants, patch, intravaginal device [NuvaRing]), intrauterine device (IUD [copper banded coils]), diaphragm, cervical cap, or condom with spermicidal jelly or foam.
- Willing and able to comply with study requirements and restrictions;
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- Groups 1- 2 (renal impairment)
- Subjects with renal impairment defined as
- Group 1: Stage 5 End Stage Renal Disease (ESRD) (eGFR < 15 mL/min/m2) requiring regularly scheduled dialysis and have been on a stable dialysis regimen for at least three months at baseline; OR
- Group 2: Stage 4 severe renal impairment (eGFR ≤ 29 mL/min/m2) but not requiring dialysis as calculated using the Modification of Diet in Renal Disease (MDRD) Equation (Appendix 18.3)
- Otherwise considered healthy in general as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening;
- Vital signs (after 3 minutes resting in a semi-supine position) which are within the ranges shown below.
- Body temperature between 35.0-37.5 °C;
- Systolic blood pressure between 100-180 mmHg;
- Diastolic blood pressure between 60-115 mmHg;
- Pulse rate between 40-100 bpm.
- Group 3 (healthy matched controls)
- Subjects in Group 3 must match in gender, smoking status, age (±10 years), and body mass index [normal BMIs (18.00-24.99), overweight BMIs (25.00-30.99) and obese BMIs (31.00-40.00)] to Group 1 and/or 2;
- Subjects must have normal renal function defined as eGFR ≥ 80 mL/min/m2 as calculated using the Modification of Diet in Renal Disease (MDRD) Equation (Appendix 18.3 );
- Subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis;
- Vital signs (after 3 minutes resting in a semi-supine position) which are within the ranges shown below:
- Body temperature between 35.0 - 37.5 °C;
- Systolic blood pressure between 90 - 150 mmHg;
- Diastolic blood pressure between 50 - 95 mmHg;
- Pulse rate between 40 - 90 bpm.
Who cannot join
- Groups 1-3
- Smokers (use of tobacco products in the previous 3 months) unable or unwilling to limit consumption to 10 cigarettes per day or less while checked into the inpatient facility.
- Note: Smoking will be a match criteria and the site should attempt to enroll an equal number of smokers and non-smokers into each group.
- Exposure to any investigation drug, including placebo, within 30 days or 5 half-lives (whichever is longer) of dosing;
- Donation or loss of 400 mL or more of blood within two months prior to dosing;
- Significant illness within the two weeks prior to dosing;
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- Answer 'yes' to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS, or answer "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) on the "Suicidal Behavior" portion of the Columbia Suicide Severity Rating Scale (C-SSRS); and the ideation or behavior occurred within the past 6 months;
- Functioning renal transplant;
- History within the past 2 years of clinically significant acute or chronic bronchospastic disease, including asthma and chronic obstructive pulmonary disease, treated or not treated;
- Treatment with any drug known to cause major organ system toxicity (e.g., chloramphenicol or tamoxifen) during the 60 day preceding the Screening visit;
- Participation in a previous BMS-214778/VEC-162 trial;
- History of drug or alcohol abuse as defined in DSM-IV, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening or evidence of such abuse as indicated by the laboratory assays conducted during the screening and baseline visits. A positive drug screen in Groups 1 and 2 is acceptable if there is documentation that subjects have been prescribed the corresponding medication;
- History of immunocompromise, including a positive HIV (ELISA and Western blot) test result;
- A positive Hepatitis B surface antigen (HBsAg) test result;
- Any surgical or medical condition which might significantly alter the absorption, distribution or excretion of any drug. The Investigator should be guided by evidence of any of the following:
- History of clinically significant inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding;
- History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
- History of pancreatic injury or pancreatitis;
- History or presence of liver disease or liver injury as indicated by lab values such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin 1.5 times greater than the upper limit of normal;
- Clinically significant ECG abnormalities or vital sign abnormalities at screening or a history of unstable, severe, or clinically significant cardiovascular disease (e.g., myocardial infarction within previous 6 months, unstable angina, cardiac failure, second/third degree atrioventricular block);
- Subjects taking any unapproved prescription or over-the-counter medications; all concomitant medications must be discussed with and approved by the sponsor prior to enrollment;
- A known hypersensitivity to tasimelteon or drugs similar to tasimelteon including melatonin;
- Pregnant or lactating females;
- Inability to swallow the study medication whole;
- Any other sound medical reason as determined by the clinical Investigator.
- Groups 1 - 2 (renal impairment)
- Subjects with clinically significant abnormal findings, not consistent with clinical disease, upon physical examination, ECG, or laboratory evaluation;
- Evidence of progressive renal disease within 4 weeks prior to screening;
- Acute renal failure or nephrotic syndrome;
- Current hematuria of urologic origin;
- Any significant change in chronic treatment medication as determined by the clinical Investigator.
- Group 3 (healthy matched controls)
- Use of unapproved prescription medication within 1 month of dosing and OTC medication within 14 days prior to dosing;
- History or presence of impaired renal function as indicated by abnormal (>ULN) creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria).
- A positive hepatitis C test result.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014
DaVita Clinical Research
Minneapolis, Minnesota
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: An Open-Label, Single-Dose, Parallel-Group Study to Compare the Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment With That in Matched Control Subjects With Relatively Normal Renal Function
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood of individuals with severe renal impairment compared to individuals who have normal renal function. The safety and tolerability of tasimelteon will also be assessed throughout this study.
- Conditions
- Renal Impairment
- Being tested
- Tasimelteon
- Keywords
- End stage renal disease, ESRD, kidney disease, renal impairment, renal
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TasimelteonDrug
Also called VEC-162
20mg capsule, once
TasimelteonDrug
20mg, once
| Study group | Role | What they receive |
|---|---|---|
| End Stage Renal Disease, dialysis | Experimental | eGFR <15 ml/min/1.73m^2 Receives: Drug: Tasimelteon |
| Severe renal impairment | Experimental | eGFR < 29 ml/min/1.73m^2 Receives: Drug: Tasimelteon |
| Healthy controls | Experimental | eGFR > 80 mL/min/1.73m^2 Matched to renally impaired subjects by age, gender, BMI, and smoking status Receives: Drug: Tasimelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tasimelteon pharmacokinetic parameters (AUC, Cmax, Tmax)
Measured: Predose, 0.25, 1, 1.5, 2, 4, 6, 8, 12, 24, 30, and 36 hours post-dose
Secondary outcomes (5)
Pharmacokinetic parameters (AUC, Cmax, Tmax) of tasimelteon metabolites M3, M9, M11, M12, M13, and M14
Measured: Predose, 0.25, 1, 1.5, 2, 4, 6, 8, 12, 24, 30, and 36 hours post-dose
The percentage of tasimelteon and its metabolites that are removed by hemodialysis (AUC)
paired arterial and venous samples
Measured: 4, 6, 8 hours after dosing
The ratio of plasma protein bound versus unbound fractions of tasimelteon and metabolites M9, M11, M12, M13, and M14
Measured: 0.5 and 3 hours post dose
Safety and tolerability as measured by spontaneous reporting of AEs, and clinically significant changes in laboratory parameters, ECG parameters, and vital signs
Measured: 36 hours
The Columbia-Suicide Severity Rating Scale will be used to assess suicidal behavior and ideation.
Measured: once per day at Screening (approximately day -7), Day -1 (baseline), Day 2 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526746
- Sponsor's protocol ID
- VP-VEC-162-1106
- Status last verified
- Feb 2014
- First submitted
- 26 Jan 2012
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Parallel-Group Study to Compare the Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment With That in Matched Control Subjects With Relatively Normal Renal Function
- ClinicalTrials.gov ID
- NCT01526746
- Acronym / sponsor ID
- VP-VEC-162-1106
- Conditions
- Renal Impairment
- Keywords
- End stage renal disease, ESRD, kidney disease, renal impairment, renal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Feb 2012 (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 research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood of individuals with severe renal impairment compared to individuals who have normal renal function. The safety and tolerability of tasimelteon will also be assessed throughout this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| End Stage Renal Disease, dialysis | Experimental | Drug: TasimelteoneGFR <15 ml/min/1.73m^2 |
| Severe renal impairment | Experimental | Drug: TasimelteoneGFR < 29 ml/min/1.73m^2 |
| Healthy controls | Experimental | Drug: TasimelteoneGFR > 80 mL/min/1.73m^2 Matched to renally impaired subjects by age, gender, BMI, and smoking status |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Groups 1-3
- Ability and acceptance to provide written informed consent;
- Men or women between 18 - 79 years, inclusive;
- Subjects with Body Mass Index (BMI) of >18 and <40 kg/m2 (BMI = weight (kg)/ [height (m)]2);
- Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 6 months before screening), or females of child-bearing potential using an acceptable method of birth control for a period of 35 days before the first dosing and have a negative pregnancy test at the screening and baseline visits; Note 1: Acceptable methods of birth control include any one of the following: abstinence, vasectomized sexual partner, hormonal methods (i.e. pill, hormonal IUD, Depo-Provera, implants, patch, intravaginal device [NuvaRing]), intrauterine device (IUD [copper banded coils]), diaphragm, cervical cap, or condom with spermicidal jelly or foam.
Key exclusion criteria (35 listed)
- Groups 1-3
- Smokers (use of tobacco products in the previous 3 months) unable or unwilling to limit consumption to 10 cigarettes per day or less while checked into the inpatient facility.
- Exposure to any investigation drug, including placebo, within 30 days or 5 half-lives (whichever is longer) of dosing;
- Donation or loss of 400 mL or more of blood within two months prior to dosing;
- Significant illness within the two weeks prior to dosing;
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 |
|---|---|---|
| TasimelteonAlso: VEC-16220mg capsule, once | Drug | End Stage Renal Disease, dialysis, Healthy controls, Severe renal impairment |
| Tasimelteon20mg, once | Drug | End Stage Renal Disease, dialysis, Healthy controls, Severe renal impairment |
Primary outcome
Tasimelteon pharmacokinetic parameters (AUC, Cmax, Tmax)
Time frame: Predose, 0.25, 1, 1.5, 2, 4, 6, 8, 12, 24, 30, and 36 hours post-dose
5 secondary outcomes
Pharmacokinetic parameters (AUC, Cmax, Tmax) of tasimelteon metabolites M3, M9, M11, M12, M13, and M14
Time frame: Predose, 0.25, 1, 1.5, 2, 4, 6, 8, 12, 24, 30, and 36 hours post-dose
The percentage of tasimelteon and its metabolites that are removed by hemodialysis (AUC)
Time frame: 4, 6, 8 hours after dosing
The ratio of plasma protein bound versus unbound fractions of tasimelteon and metabolites M9, M11, M12, M13, and M14
Time frame: 0.5 and 3 hours post dose
Safety and tolerability as measured by spontaneous reporting of AEs, and clinically significant changes in laboratory parameters, ECG parameters, and vital signs
Time frame: 36 hours
The Columbia-Suicide Severity Rating Scale will be used to assess suicidal behavior and ideation.
Time frame: once per day at Screening (approximately day -7), Day -1 (baseline), Day 2 (end of study)
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 17 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 Tasimelteon in people with Renal Impairment, run by Vanda Pharmaceuticals at 3 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 25 inclusion and 35 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 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Tasimelteon pharmacokinetic parameters (AUC, Cmax, Tmax) (time frame: Predose, 0.25, 1, 1.5, 2, 4, 6, 8, 12, 24, 30, and 36 hours post-dose). 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 17 Feb 2014.