HealthyPhase 1NCT00386490
Safety of Larazotide Acetate in Healthy Volunteers
A Phase 1 study testing larazotide acetate in people with Healthy, run by 9 Meters Biopharma, Inc. at 1 site in United States.
Trial summary
To demonstrate the safety, tolerance and pharmacokinetics of multiple, oral doses of larazotide acetate. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- larazotide acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2006to 27 Feb 2006
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects
- BMI between 18 and 30.
Who cannot join
- Subjects with clinically significant abnormal clinical lab results
- Hemoglobin < 12g/dL
- Subjects with diarrhea within 3 days prior to treatment visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo Controlled, Multi-Dose Study to Determine the Safety, Tolerance and Pharmacokinetics of 3 Dose Levels of Larazotide Acetate (AT-1001) in Healthy Volunteers
To demonstrate the safety, tolerance and pharmacokinetics of multiple, oral doses of larazotide acetate.
Read the detailed description
CLIN1001-003 was a Phase 1, randomized, double-blind, placebo controlled multi-dose study to determine the safety, tolerance, and pharmacokinetics (including food effect) of 3 dose levels of larazotide acetate in healthy volunteers. Three (3) cohorts of 8 subjects, in which six (6) subjects in each cohort received larazotide acetate in escalating doses of 0.25 mg, 1 mg, or 4 mg TID for 10 days and two (2) subjects received placebo TID for 10 days, were studied. Subjects maintained a standard gluten-free diet. Subjects were dosed three times a day 30 minutes prior to meals except for the morning dosing on Days 1, 5, and 10. For the morning dosing on Days 1, 5, and 10 subjects, fasted overnight prior to dosing and for 2 hours post dose. Subjects were evaluated for safety (medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiograms) throughout the study. Serial blood samples were collected or pharmacokinetic determinations at baseline and 2 hours post morning dose on Days 1, 2, 5, 6 and 10.
- Conditions
- Healthy
- Being tested
- larazotide acetate
- Keywords
- celiac disease, larazotide acetate
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
larazotide acetateDrug
Also called AT-1001, INN-202
capsule for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Larazotide acetate 0.25 mg | Experimental | larazotide acetate 0.25 mg capsule TID for 10 days Receives: Drug: larazotide acetate |
| Larazotide acetate 1 mg | Experimental | larazotide acetate 1 mg capsule TID for 10 days Receives: Drug: larazotide acetate |
| Larazotide acetate 4 mg | Experimental | larazotide acetate 4 mg capsule TID for 10 days Receives: Drug: larazotide acetate |
| Placebo | Experimental | Placebo capsule TID for 10 days Receives: Drug: larazotide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the safety and tolerance of multiple, oral doses of larazotide acetate
Safety evaluations included medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiograms
Measured: Subjects were evaluated for safety at screening, prior to administration of treatment, and following dosing of the study drug.
Determine whether quantifiable concentrations of larazotide acetate are present in plasma following multiple oral doses and characterize the pharmacokinetic behavior of larazotide acetate in healthy subjects that are gluten-free and in remission
Pharmacokinetic samples were taken to determine whether quantifiable concentrations of larazotide acetate were present in plasma following multiple oral doses and to characterize the pharmacokinetic behavior of larazotide acetate in celiac disease subjects.
Measured: Serial blood samples were collected for pharmacokinetic determinations at baseline and 2 hours post morning dose on Days 1, 2, 5, 6 and 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study start10 Jan 2006
- Primary completion27 Feb 2006
- Study completion27 Feb 2006
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Phase 1, randomized, double-blind, placebo controlled multi-dose study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- 9 Meters Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Blake Paterson, MD, Study chair, Alba Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386490
- Sponsor's protocol ID
- CLIN1001-003
- Status last verified
- Sep 2017
- First submitted
- 9 Oct 2006
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo Controlled, Multi-Dose Study to Determine the Safety, Tolerance and Pharmacokinetics of 3 Dose Levels of Larazotide Acetate (AT-1001) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00386490
- Acronym / sponsor ID
- CLIN1001-003
- Conditions
- Healthy
- Keywords
- celiac disease, larazotide acetate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- 9 Meters Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2006 (actual)
- Primary completion
- 27 Feb 2006 (actual)
- Study completion
- 27 Feb 2006 (actual)
- First posted
- 11 Oct 2006 (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.
To demonstrate the safety, tolerance and pharmacokinetics of multiple, oral doses of larazotide acetate.
Detailed description
CLIN1001-003 was a Phase 1, randomized, double-blind, placebo controlled multi-dose study to determine the safety, tolerance, and pharmacokinetics (including food effect) of 3 dose levels of larazotide acetate in healthy volunteers. Three (3) cohorts of 8 subjects, in which six (6) subjects in each cohort received larazotide acetate in escalating doses of 0.25 mg, 1 mg, or 4 mg TID for 10 days and two (2) subjects received placebo TID for 10 days, were studied. Subjects maintained a standard gluten-free diet. Subjects were dosed three times a day 30 minutes prior to meals except for the morning dosing on Days 1, 5, and 10. For the morning dosing on Days 1, 5, and 10 subjects, fasted overnight prior to dosing and for 2 hours post dose. Subjects were evaluated for safety (medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiograms) throughout the study. Serial blood samples were collected or pharmacokinetic determinations at baseline and 2 hours post morning dose on Days 1, 2, 5, 6 and 10.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Phase 1, randomized, double-blind, placebo controlled multi-dose study
| Arm | Type | Receives |
|---|---|---|
| Larazotide acetate 0.25 mg | Experimental | Drug: larazotide acetatelarazotide acetate 0.25 mg capsule TID for 10 days |
| Larazotide acetate 1 mg | Experimental | Drug: larazotide acetatelarazotide acetate 1 mg capsule TID for 10 days |
| Larazotide acetate 4 mg | Experimental | Drug: larazotide acetatelarazotide acetate 4 mg capsule TID for 10 days |
| Placebo | Experimental | Drug: larazotide acetatePlacebo capsule TID for 10 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female subjects
- BMI between 18 and 30.
Key exclusion criteria (3 listed)
- Subjects with clinically significant abnormal clinical lab results
- Hemoglobin < 12g/dL
- Subjects with diarrhea within 3 days prior to treatment visit
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 |
|---|---|---|
| larazotide acetateAlso: AT-1001, INN-202capsule for oral administration | Drug | Larazotide acetate 0.25 mg, Larazotide acetate 1 mg, Larazotide acetate 4 mg, Placebo |
Primary outcome
Demonstrate the safety and tolerance of multiple, oral doses of larazotide acetate
Time frame: Subjects were evaluated for safety at screening, prior to administration of treatment, and following dosing of the study drug.
Safety evaluations included medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiograms
Determine whether quantifiable concentrations of larazotide acetate are present in plasma following multiple oral doses and characterize the pharmacokinetic behavior of larazotide acetate in healthy subjects that are gluten-free and in remission
Time frame: Serial blood samples were collected for pharmacokinetic determinations at baseline and 2 hours post morning dose on Days 1, 2, 5, 6 and 10.
Pharmacokinetic samples were taken to determine whether quantifiable concentrations of larazotide acetate were present in plasma following multiple oral doses and to characterize the pharmacokinetic behavior of larazotide acetate in celiac disease subjects.
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 12 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Blake Paterson, MD study chair
Alba Therapeutics
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 larazotide acetate in people with Healthy, run by 9 Meters Biopharma, Inc. 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 2 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 12 Sep 2017. 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?
Demonstrate the safety and tolerance of multiple, oral doses of larazotide acetate (time frame: Subjects were evaluated for safety at screening, prior to administration of treatment, and following dosing of the study drug.). The study lists 2 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 12 Sep 2017.