Basic Science: Safety, Tolerability, Efficacy of CLPPhase 1NCT01944007
Evaluation of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
A Phase 1 study testing Cross-Linked Polyelectrolyte (CLP) in people with Basic Science: Safety, Tolerability, Efficacy of CLP, run by Sorbent Therapeutics at 1 site in United States.
Trial summary
This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Basic Science: Safety, Tolerability, Efficacy of CLP
- What is being tested?
- Cross-Linked Polyelectrolyte (CLP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Mar 2008
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or females between the ages of 18 and 70 years
- Body mass index (BMI) between 18 and 32 kg/m^2, inclusive
- Females could not be pregnant or breast feeding and had to be using birth control
Who cannot join
- Positive drug screen for substances of abuse
- Positive results for HIV, hepatitis B, or hepatitis C
- Screening 12-lead ECG demonstrating QTc interval >430 msec for males and >450 msec for females, or any cardiac rhythm disorder considered by the Investigator to be clinically relevant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Phase 1 Multiple Dose Escalation Trial to Assess the Safety, Tolerability, and Efficacy of Capsules Containing Cross-linked Polyelectrolyte (CLP) Given to Normal Healthy Volunteers
This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.
- Being tested
- Cross-Linked Polyelectrolyte (CLP)
- Keywords
- CLP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-Linked Polyelectrolyte (CLP)Drug
CLP was administered orally, in capsules, for 9 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| CLP 15 g Fed | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack Receives: Drug: Cross-Linked Polyelectrolyte (CLP) |
| CLP 25 g Fed | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack Receives: Drug: Cross-Linked Polyelectrolyte (CLP) |
| CLP 7.5 g Fed | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack Receives: Drug: Cross-Linked Polyelectrolyte (CLP) |
| CLP 15 g fasted | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d 1 hour prior to 4 standardized meals/snack Receives: Drug: Cross-Linked Polyelectrolyte (CLP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Sodium Balance
Daily net sodium balance was calculated based on dietary and fluid intake, urinary and fecal output and emesis.
Measured: Days 5 - 9
Secondary outcomes (5)
Total Fecal Weight
Total fecal weight throughout 9-day treatment period, and mean fecal weights (daily avg. of Days 5-9)
Measured: Days 1-9
Net Balance of Potassium, Magnesium, Calcium, and Phosphorous
The net balance of cations was calculated based on dietary and fluid intake, urinary and fecal output, and emesis.
Measured: Days 5-9
Fecal content and concentration of sodium, potassium, magnesium, calcium, phosphorous, iron, zinc, and copper
Measured: Days 5-9
Urine content and concentration of sodium, potassium, magnesium, calcium, and phosphorous
Measured: Days 5-9
Serum concentrations of sodium, potassium, magnesium, calcium, and phosphorous
Measured: Days 5-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startDec 2007
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Basic Science: Safety, Tolerability, Efficacy of CLPStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorbent Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Blok, MD, Principal investigator, Jasper Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944007
- Sponsor's protocol ID
- CTST-5
- Status last verified
- Sep 2013
- First submitted
- 12 Sep 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Henderson LW, Dittrich HC, Strickland A, Blok TM, Newman R, Oliphant T, Albrecht D. A Phase 1 dose-ranging study examining the effects of a superabsorbent polymer (CLP) on fluid, sodium and potassium excretion in healthy subjects. BMC Pharmacol Toxicol. 2014 Jan 25;15:2. doi: 10.1186/2050-6511-15-2.
PubMed 24460668
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Phase 1 Multiple Dose Escalation Trial to Assess the Safety, Tolerability, and Efficacy of Capsules Containing Cross-linked Polyelectrolyte (CLP) Given to Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01944007
- Acronym / sponsor ID
- CTST-5
- Keywords
- CLP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sorbent TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2008 (actual)
- First posted
- 17 Sep 2013 (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.
This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CLP 15 g Fed | Experimental | Drug: Cross-Linked Polyelectrolyte (CLP)Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack |
| CLP 25 g Fed | Experimental | Drug: Cross-Linked Polyelectrolyte (CLP)Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack |
| CLP 7.5 g Fed | Experimental | Drug: Cross-Linked Polyelectrolyte (CLP)Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack |
| CLP 15 g fasted | Experimental | Drug: Cross-Linked Polyelectrolyte (CLP)Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d 1 hour prior to 4 standardized meals/snack |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males or females between the ages of 18 and 70 years
- Body mass index (BMI) between 18 and 32 kg/m^2, inclusive
- Females could not be pregnant or breast feeding and had to be using birth control
Key exclusion criteria (3 listed)
- Positive drug screen for substances of abuse
- Positive results for HIV, hepatitis B, or hepatitis C
- Screening 12-lead ECG demonstrating QTc interval >430 msec for males and >450 msec for females, or any cardiac rhythm disorder considered by the Investigator to be clinically relevant
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 |
|---|---|---|
| Cross-Linked Polyelectrolyte (CLP)CLP was administered orally, in capsules, for 9 consecutive days. | Drug | CLP 15 g Fed, CLP 15 g fasted, CLP 25 g Fed, CLP 7.5 g Fed |
Primary outcome
Net Sodium Balance
Time frame: Days 5 - 9
Daily net sodium balance was calculated based on dietary and fluid intake, urinary and fecal output and emesis.
5 secondary outcomes
Total Fecal Weight
Time frame: Days 1-9
Net Balance of Potassium, Magnesium, Calcium, and Phosphorous
Time frame: Days 5-9
Fecal content and concentration of sodium, potassium, magnesium, calcium, phosphorous, iron, zinc, and copper
Time frame: Days 5-9
Urine content and concentration of sodium, potassium, magnesium, calcium, and phosphorous
Time frame: Days 5-9
Serum concentrations of sodium, potassium, magnesium, calcium, and phosphorous
Time frame: Days 5-9
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 Sep 2013.
- Derived from this study: PubMed 24460668Henderson LW, Dittrich HC, Strickland A, Blok TM, Newman R, Oliphant T, Albrecht D. A Phase 1 dose-ranging study examining the effects of a superabsorbent polymer (CLP) on fluid, sodium and potassium excretion in healthy subjects. BMC Pharmacol Toxicol. 2014 Jan 25;15:2. doi: 10.1186/2050-6511-15-2.
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.
Thomas Blok, MD principal investigator
Jasper Clinic, Inc.
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 Cross-Linked Polyelectrolyte (CLP) in people with Basic Science: Safety, Tolerability, Efficacy of CLP, run by Sorbent Therapeutics 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 3 inclusion and 3 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 Sep 2013. 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?
Net Sodium Balance (time frame: Days 5 - 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01944007, which also lists 1 linked publication.
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 Sep 2013.