Renal ImpairmentPhase 1NCT01578928
A Phase l Study to Evaluate the Pharmacokinetics and Safety Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Volunteers
A Phase 1 study testing SOM230 in people with Renal Impairment, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of pasireotide,the PK of pasireotide in subjects with different degrees of renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- SOM230
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2012to May 2014
- 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
- Subjects eligible for inclusion in this study have to meet all of the following criteria:
- Written informed consent obtained prior to any screening procedures.
- Subjects must be able to communicate well with the investigator and comply with the requirements of the study procedures
- Male or female subjects between 18 and 75 years of age, inclusive.
- Vital Signs at screening and baseline which are within the following ranges:
- Oral body temperature: ≥ 35.0 and ≤ 37.5 ˚C
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- Pulse rate: 40-90 bpm
- Subjects must have a BMI between 20 kg/m2 and 30 kg/m2 and weigh at least 50 kg and no more than 120 kg.
- Subjects must be willing to comply with dietary, fluid, and lifestyle restrictions (from day-1 to study completion).
- Other than renal impairment, subjects must be stable and appropriately managed relative to chronic diseases (such as diabetes and hypertension) as determined by past medical history, physical examination, electrocardiogram, and laboratory tests for chemistry and hematology.
- For renal impairment subjects only
- Subjects must have stable renal disease without evidence of renal progressive disease (stable renal disease is defined as no significant change, such as, stable eGFR, for 12 weeks prior to study entry).
- Blood pressure (3 minutes resting before measurement) in the supine position:
- Systolic: 90-165 mmHg
- Diastolic: 60-110 mmHg
- For control subjects only
- Subjects must be matched to at least one renal impaired subject by gender, age (±10 years), body weight (±20%), BMI (±5%) and race.
- Blood pressure (3 minutes resting before measurement) in the supine position:
- Systolic: 90-140 mmHg
- Diastolic: 50-90 mmHg
Who cannot join
- Subjects eligible for this study must not meet any of the following criteria:
- Clinically significant abnormal laboratory values at the screening evaluation or at the baseline re-evaluation, excluding those normally associated with mild to severe degree of renal impairment or the primary cause of renal insufficiency
- Use of any over-the-counter medications or vitamins or herbal/natural supplements during 2 weeks prior to dosing (acetaminophen is acceptable, and must be documented in the Concomitant Medications/Non-Drug Therapies page of the CRF)
- Current medical history of the following:
- Sustained or clinically significant cardiac arrhythmias
- History of syncope or family history of idiopathic sudden death
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- Risk factors for torsades de pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high grade AV block
- Screening QTcF > 450ms
- Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
- Concomitant medications known to increase the QT interval
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation
- Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or other amount considered to compromise the health of the subject if previous history of anemia exists
- Significant acute illness within the two weeks prior to dosing
- History of immunocompromise, including a positive HIV (ELISA and Western blot) test result
- History of allergies to the investigational compound/compound class being used in the study
- A positive Hepatitis B surface antigen (HBsAg) or positive HCV antibody
- History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations
- History of liver disease, such as cirrhosis or chronic active hepatitis B and C.
- Known gallbladder or bile duct disease, acute or chronic pancreatitis
- Baseline ALT or AST > ULN
- Baseline total bilirubin > 1.5x ULN
- Subjects on dialysis
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 5 times the terminal half-life of study treatment (6 days). Highly effective contraception methods include:
- Total abstinence or
- Male or female sterilization or
- Combination of any two of the following (a+b or a+c, or b+c):
- Use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
- Sexually active males unless they use a condom during intercourse while taking drug and for 5 half-lives (6 days) after stopping SOM230 medication and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
- Potentially unreliable or vulnerable subjects (e.g. person kept in detention) and those judged by the investigator to be unsuitable for the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Africa1 site
Novartis Investigative Site
Bloemfontein, Free State, 9300
About this study
Official title: A Phase I, Open-label, Multicenter, Single Dose Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous (s.c.) Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to a Matched Control Group of Healthy Volunteers
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of pasireotide,the PK of pasireotide in subjects with different degrees of renal impairment.
Read the detailed description
This is a phase I, open-label, multicenter, single dose study to evaluate the PK and safety of pasireotide s.c. injection in subjects with varying degrees of renal impairment compared to healthy subjects with normal renal function. Subjects will be classified by their respective degree of renal functions (normal, mild, moderate, severe, and ESRD (End Stage Renal Disease) according to eGFR as determined at the screening visit.
- Conditions
- Renal Impairment
- Being tested
- SOM230
- Keywords
- renal, impairment, endstage renal disease, renal, impairment, endstage renal disease
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOM230Drug
| Study group | Role | What they receive |
|---|---|---|
| SOM230 | Experimental | subjects with varying degrees of renal impairment along with subjects without renal impairment Receives: Drug: SOM230 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and Urine PK parameters
Description: Cmax, AUCinf, AUClast, CL/F, CLR, glucose, insulin, glucagon
Measured: pre-dose (-1 min) and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12, 24, 36, 48, 72, 96, 120 and 122 hours post-dose
Secondary outcomes (1)
Additional PK parameters
Description: Vz/F, T1/2, Fu, Cmax,u, AUCinf,u, AUClast,u, CLu/F and Vu/F
Measured: pre-dose (-1 min) and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 24, 36, 48, 72, 96, 120 and 122 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2014
- Study completionMay 2014
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 Novartis 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578928
- Sponsor's protocol ID
- CSOM230B2126
- Other IDs
- 2011-005922-23
- Status last verified
- Sep 2020
- First submitted
- 12 Apr 2012
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multicenter, Single Dose Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous (s.c.) Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to a Matched Control Group of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01578928
- Acronym / sponsor ID
- CSOM230B2126
- Conditions
- Renal Impairment
- Keywords
- renal, impairment, endstage renal disease, renal, impairment, endstage renal disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Apr 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 study is to assess the effect of renal impairment on the pharmacokinetics (PK) of pasireotide,the PK of pasireotide in subjects with different degrees of renal impairment.
Detailed description
This is a phase I, open-label, multicenter, single dose study to evaluate the PK and safety of pasireotide s.c. injection in subjects with varying degrees of renal impairment compared to healthy subjects with normal renal function. Subjects will be classified by their respective degree of renal functions (normal, mild, moderate, severe, and ESRD (End Stage Renal Disease) according to eGFR as determined at the screening visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOM230 | Experimental | Drug: SOM230subjects with varying degrees of renal impairment along with subjects without renal impairment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Written informed consent obtained prior to any screening procedures.
- Subjects must be able to communicate well with the investigator and comply with the requirements of the study procedures
- Male or female subjects between 18 and 75 years of age, inclusive.
- Vital Signs at screening and baseline which are within the following ranges:
- Subjects must have a BMI between 20 kg/m2 and 30 kg/m2 and weigh at least 50 kg and no more than 120 kg.
Key exclusion criteria (31 listed)
- Clinically significant abnormal laboratory values at the screening evaluation or at the baseline re-evaluation, excluding those normally associated with mild to severe degree of renal impairment or the primary cause of renal insufficiency
- Use of any over-the-counter medications or vitamins or herbal/natural supplements during 2 weeks prior to dosing (acetaminophen is acceptable, and must be documented in the Concomitant Medications/Non-Drug Therapies page of the CRF)
- Current medical history of the following:
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation
- Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or other amount considered to compromise the health of the subject if previous history of anemia exists
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 |
|---|---|---|
| SOM230 | Drug | SOM230 |
Primary outcome
Plasma and Urine PK parameters
Time frame: pre-dose (-1 min) and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12, 24, 36, 48, 72, 96, 120 and 122 hours post-dose
Description: Cmax, AUCinf, AUClast, CL/F, CLR, glucose, insulin, glucagon
1 secondary outcome
Additional PK parameters
Time frame: pre-dose (-1 min) and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 24, 36, 48, 72, 96, 120 and 122 hours post-dose
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 21 Dec 2020.
- Results for CSOM230B2126 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SOM230 in people with Renal Impairment, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
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 20 inclusion and 31 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 21 Dec 2020. 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 Germany, South Africa. 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?
Plasma and Urine PK parameters (time frame: pre-dose (-1 min) and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12, 24, 36, 48, 72, 96, 120 and 122 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 21 Dec 2020.