Irritable Bowel SyndromePhase 1NCT01411800
An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects
A Phase 1 study testing 250 mg capsule and 250 mg tablets in people with Irritable Bowel Syndrome, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- 250 mg capsule and 250 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult subjects age 18 to 55 years
- Vital signs acceptable at Screening
- Body mass index (BMI) between 18 and 35 kg/m^2 at Screening
- Considered to be in good health, as determined by the Investigator
- Normal ECG findings
- Negative urine screen for drugs of abuse and negative breath test for alcohol
- Negative hepatitis B surface antigen, hepatitis C antibody, and HIV1 and HIV2 antibody tests within the last 28 days
- Ability to provide written informed consent
Who cannot join
- Use of any medication (including acetaminophen) within 5 days of dosing
- Use of any investigational agent or selective serotonin reuptake inhibitors (SSRIs) within 30 days of study start
- Administration of any protein or antibodies within 90 days of study start
- Donation or loss of greater than 450 mL of blood within 45 days of study start
- Known history of hepatic disease or significantly abnormal liver function tests
- History of alcoholism or substance abuse within 3 years prior to study start
- Participation in any other clinical study within 30 days preceding the first dose of study drug
- Positive serum pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexicon Investigational Site
Overland Park, Kansas, 66211
About this study
Official title: A Phase 1, Randomized, Open-Label, Two-Way Crossover Study of Two Oral Formulations of LX1033 in Healthy Human Subjects
The purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy volunteers.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- 250 mg capsule, 250 mg tablets
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
250 mg capsuleDrug
Two 250 mg capsules will be administered for 500 mg dose
250 mg tabletsDrug
Two 250 mg tablets will be administered for a 500 mg dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 500 mg LX1033, capsules administered two times per day orally Receives: Drug: 250 mg capsule |
| Treatment B | Experimental | 500 mg LX1033, tablets administered two times per day orally Receives: Drug: 250 mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary 5-HIAA levels
Measured: 34 days
Plasma 5-HIAA levels
Measured: 30 days
Secondary outcomes (3)
Maximum observed plasma concentration
Measured: 32 days
Time at which maximum observed plasma concentration occurs
Measured: 32 days
Half-life of the drug in plasma
Measured: 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ikenna Ogbaa, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411800
- Sponsor's protocol ID
- LX1033.1-103-NRM
- Other IDs
- LX1033.103
- Status last verified
- Jul 2012
- First submitted
- 5 Aug 2011
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Two-Way Crossover Study of Two Oral Formulations of LX1033 in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT01411800
- Acronym / sponsor ID
- LX1033.1-103-NRM
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Aug 2011 (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 pharmacodynamic effects, pharmacokinetics, and safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: 250 mg capsule500 mg LX1033, capsules administered two times per day orally |
| Treatment B | Experimental | Drug: 250 mg tablets500 mg LX1033, tablets administered two times per day orally |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adult subjects age 18 to 55 years
- Vital signs acceptable at Screening
- Body mass index (BMI) between 18 and 35 kg/m^2 at Screening
- Considered to be in good health, as determined by the Investigator
- Normal ECG findings
Key exclusion criteria (8 listed)
- Use of any medication (including acetaminophen) within 5 days of dosing
- Use of any investigational agent or selective serotonin reuptake inhibitors (SSRIs) within 30 days of study start
- Administration of any protein or antibodies within 90 days of study start
- Donation or loss of greater than 450 mL of blood within 45 days of study start
- Known history of hepatic disease or significantly abnormal liver function tests
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 |
|---|---|---|
| 250 mg capsuleTwo 250 mg capsules will be administered for 500 mg dose | Drug | Treatment A |
| 250 mg tabletsTwo 250 mg tablets will be administered for a 500 mg dose | Drug | Treatment B |
Primary outcome
Urinary 5-HIAA levels
Time frame: 34 days
Plasma 5-HIAA levels
Time frame: 30 days
3 secondary outcomes
Maximum observed plasma concentration
Time frame: 32 days
Time at which maximum observed plasma concentration occurs
Time frame: 32 days
Half-life of the drug in plasma
Time frame: 32 days
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 20 Jul 2012.
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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.
Ikenna Ogbaa, MD study director
Lexicon Pharmaceuticals, 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 250 mg capsule and 250 mg tablets in people with Irritable Bowel Syndrome, run by Lexicon Pharmaceuticals 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 8 inclusion and 8 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 20 Jul 2012. 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?
Urinary 5-HIAA levels (time frame: 34 days). 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 20 Jul 2012.