HealthyPhase 1NCT02079233
Evaluation of Four Different Dosing Regimens of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
A Phase 1 study testing Cross-Linked Polyelectrolyte (CLP) in people with Healthy, run by Sorbent Therapeutics.
Trial summary
This is a study to determine the effect of four different dosing regimens of CLP in normal healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- No sites listed yet
- Study dates
- May 2010to Jul 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer is ≥ 18 years of age with BMI of 18-32
- Females could not be pregnant or breast feeding and had to be using birth control
- Must have regular bowel habits, typically producing at least 1 daily bowel movement
Who cannot join
- 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
- History or presence of gastrointestinal conditions
- Positive drug screen for substances of abuse
- Positive results for HIV, hepatitis B, or hepatitis C
About this study
Official title: Phase 1 Multiple Dose Trial to Assess the Safety, Tolerability and Efficacy of Four Different Dosing Regimens of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
This is a study to determine the effect of four different dosing regimens of CLP in normal healthy volunteers.
- Conditions
- Healthy
- Being tested
- Cross-Linked Polyelectrolyte (CLP)
- Keywords
- Basic Science, Safety, Tolerability, Efficacy of 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 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| CLP 15 g QD | Experimental | Cross-Linked Polyelectrolyte (CLP) study medication delivered immediately before bedtime Receives: Drug: Cross-Linked Polyelectrolyte (CLP) |
| CLP 7.5 g BID | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered b.i.d. one hour before breakfast and dinner Receives: Drug: Cross-Linked Polyelectrolyte (CLP) |
| CLP 5 g TID | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered t.i.d. one hour before breakfast, lunch and dinner Receives: Drug: Cross-Linked Polyelectrolyte (CLP) |
| CLP 3.75 g QID | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d on hour before breakfast, lunch, dinner and immediately before bedtime Receives: Drug: Cross-Linked Polyelectrolyte (CLP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal sodium content
The primary endpoint was sodium removal from the stool compared between the Baseline period and the Treatment Period.
Measured: Baseline (Days 3-6) vs. Treatment (Days 10-13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMay 2010
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- 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
- Shanthini A. Daniel, MD, Principal investigator, Jasper Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079233
- Sponsor's protocol ID
- CTST-16
- Status last verified
- Mar 2014
- First submitted
- 3 Mar 2014
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Multiple Dose Trial to Assess the Safety, Tolerability and Efficacy of Four Different Dosing Regimens of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02079233
- Acronym / sponsor ID
- CTST-16
- Conditions
- Healthy
- Keywords
- Basic Science, Safety, Tolerability, Efficacy of CLP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sorbent TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2010 (actual)
- First posted
- 5 Mar 2014 (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 study to determine the effect of four different dosing regimens of CLP in normal healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CLP 15 g QD | Experimental | Drug: Cross-Linked Polyelectrolyte (CLP)Cross-Linked Polyelectrolyte (CLP) study medication delivered immediately before bedtime |
| CLP 7.5 g BID | Experimental | Drug: Cross-Linked Polyelectrolyte (CLP)Cross-Linked Polyelectrolyte (CLP) Study medication delivered b.i.d. one hour before breakfast and dinner |
| CLP 5 g TID | Experimental | Drug: Cross-Linked Polyelectrolyte (CLP)Cross-Linked Polyelectrolyte (CLP) Study medication delivered t.i.d. one hour before breakfast, lunch and dinner |
| CLP 3.75 g QID | Experimental | Drug: Cross-Linked Polyelectrolyte (CLP)Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d on hour before breakfast, lunch, dinner and immediately before bedtime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteer is ≥ 18 years of age with BMI of 18-32
- Females could not be pregnant or breast feeding and had to be using birth control
- Must have regular bowel habits, typically producing at least 1 daily bowel movement
Key exclusion criteria (4 listed)
- 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
- History or presence of gastrointestinal conditions
- Positive drug screen for substances of abuse
- Positive results for HIV, hepatitis B, or hepatitis C
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 7 consecutive days. | Drug | CLP 15 g QD, CLP 3.75 g QID, CLP 5 g TID, CLP 7.5 g BID |
Primary outcome
Change in fecal sodium content
Time frame: Baseline (Days 3-6) vs. Treatment (Days 10-13)
The primary endpoint was sodium removal from the stool compared between the Baseline period and the Treatment Period.
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 5 Mar 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.
Shanthini A. Daniel, MD principal investigator
Jasper Clinic, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cross-Linked Polyelectrolyte (CLP) in people with Healthy, run by Sorbent Therapeutics.
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 4 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 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in fecal sodium content (time frame: Baseline (Days 3-6) vs. Treatment (Days 10-13)). 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 5 Mar 2014.