Carcinoid SyndromePhase 1LX1606-104NCT01932528
An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males
A Phase 1 study testing 500 mg [14C]-LX1606 in people with Carcinoid Syndrome, run by Lexicon Pharmaceuticals at 1 site in United Kingdom.
Trial summary
To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Carcinoid Syndrome
- What is being tested?
- 500 mg [14C]-LX1606
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Sep 2013
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects aged 30 to 65 years of age.
- Male subjects and their partners must agree to use an adequate method of contraception
- Historically able to produce a minimum of 1 bowel movement every day on most days
Who cannot join
- Female subjects
- Use of any medication or supplement within 5 days prior to Dosing
- Radiation exposure exceeding 5 millisieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
- Current smokers or the use of cigarettes within 90 days prior to Screening
- History or renal disease or abnormal kidney function
- History of hepatic disease
- Acute diarrhea or constipation within 7 days of dosing
- Positive urine glucose at Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Non-randomised, Single-dose Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate (LX1606) in Healthy Male Subjects
To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.
- Conditions
- Carcinoid Syndrome
- Being tested
- 500 mg [14C]-LX1606
- Keywords
- Absorption, Metabolism, Excretion
- Medical subject headings
- Serotonin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500 mg [14C]-LX1606Drug
500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as [14C]-LX1606.
| Study group | Role | What they receive |
|---|---|---|
| 500 mg LX606 | Experimental | All subjects will receive a single oral 500 mg dose of [14C]-LX1606. Receives: Drug: 500 mg [14C]-LX1606 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration of LX1606 and LX1033
Measured: 7 days
Secondary outcomes (6)
Time to maximum plasma concentration of and LX1033
Measured: 7 days
Determination of total radioactivity in blood and plasma
Measured: 7 days
Mass balance recovery of total radioactivity in urine and feces
Measured: 7 days
Metabolite profiling and identification in plasma
Measured: 7 days
Metabolic profiling and identification in urine
Measured: 7 days
Metabolic profiling and identification in feces
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoid 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doug Fleming, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932528
- Sponsor's protocol ID
- LX1606.1-104-NRM
- Acronym
- LX1606-104
- Status last verified
- Oct 2013
- First submitted
- 27 Aug 2013
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Non-randomised, Single-dose Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate (LX1606) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01932528
- Acronym / sponsor ID
- LX1606-104 / LX1606.1-104-NRM
- Conditions
- Carcinoid Syndrome
- Keywords
- Absorption, Metabolism, Excretion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Sep 2013 (actual)
- First posted
- 30 Aug 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.
To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 500 mg LX606 | Experimental | Drug: 500 mg [14C]-LX1606All subjects will receive a single oral 500 mg dose of [14C]-LX1606. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male subjects aged 30 to 65 years of age.
- Male subjects and their partners must agree to use an adequate method of contraception
- Historically able to produce a minimum of 1 bowel movement every day on most days
Key exclusion criteria (8 listed)
- Female subjects
- Use of any medication or supplement within 5 days prior to Dosing
- Radiation exposure exceeding 5 millisieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
- Current smokers or the use of cigarettes within 90 days prior to Screening
- History or renal disease or abnormal kidney function
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 |
|---|---|---|
| 500 mg [14C]-LX1606500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as [14C]-LX1606. | Drug | 500 mg LX606 |
Primary outcome
Maximum plasma concentration of LX1606 and LX1033
Time frame: 7 days
6 secondary outcomes
Time to maximum plasma concentration of and LX1033
Time frame: 7 days
Determination of total radioactivity in blood and plasma
Time frame: 7 days
Mass balance recovery of total radioactivity in urine and feces
Time frame: 7 days
Metabolite profiling and identification in plasma
Time frame: 7 days
Metabolic profiling and identification in urine
Time frame: 7 days
Metabolic profiling and identification in feces
Time frame: 7 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 23 Oct 2013.
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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.
Doug Fleming, 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 500 mg [14C]-LX1606 in people with Carcinoid Syndrome, run by Lexicon Pharmaceuticals at 1 site in United Kingdom.
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 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 23 Oct 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 Kingdom. 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?
Maximum plasma concentration of LX1606 and LX1033 (time frame: 7 days). 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 23 Oct 2013.