QT IntervalPhase 1NCT02155205
A Thorough QT Study of Telotristat Etiprate
A Phase 1 study testing Telotristat etiprate and Moxifloxacin in people with QT Interval, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that telotristat etiprate does not differ from placebo in the mean change from Baseline QT interval corrected for heart rate. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- QT Interval
- What is being tested?
- Telotristat etiprate and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 2014
- 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
- Healthy adult males or females ≥18 to ≤55 years of age (inclusive) at the time of Screening
- Body mass index ≥18 to ≤32 kg/m2 at Screening
- Vital signs (after at least 5 minutes resting in a supine position) at Screening which are within the following ranges: Systolic blood pressure 90 to 140 mm Hg, Diastolic blood pressure 50 to 90 mm Hg, heart rate 45 to 100 beats per minute (bpm)
- Clinical laboratory evaluations (including clinical chemistry panel [fasted at least 10 hours], complete blood count, and urinalysis [UA]) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator
- Able to tolerate prolonged periods of quiet, motionless, supervised rest
- Willing to adhere to the prohibitions and restrictions specified in this protocol
- Able to comprehend and willing to sign an Informed Consent Form
Who cannot join
- Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator or Sponsor, may interfere with any aspect of study conduct or interpretation of results
- >30 premature ventricular beats per hour on the Holter ECG monitoring at Day -1 of Period 1 (monitored at the clinic via telemetry)
- History of additional risk factors for torsade de pointes or the diagnosis or suggestion of a family history of short QT syndrome or long QT syndrome
- History of renal disease or significantly abnormal kidney function tests
- History of hepatic disease or significantly abnormal liver function tests
- History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, or gastrointestinal abnormality
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- Concurrent conditions that could interfere with safety and tolerability measurements
- Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens
- Use of tobacco, use of medications, or history of any disease or condition that might interfere with the conduct of the study in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexicon Investigational Site
Evansville, Indiana, 47710
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Positive Controlled, 3-period, 6-sequence, Crossover Study to Define the Electrocardiogram Effects of a Single Dose of Telotristat Etiprate (LX1606) 1500 mg Compared With Placebo and Open Label Moxifloxacin in Healthy Subjects: A Thorough QT Study
The purpose of this study is to demonstrate that telotristat etiprate does not differ from placebo in the mean change from Baseline QT interval corrected for heart rate.
- Conditions
- QT Interval
- Being tested
- Telotristat etiprate, Placebo, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telotristat etiprateDrug
1500 mg telotristat etiprate (six 250 mg tablets)
PlaceboDrug
Matching placebo
MoxifloxacinDrug
400 mg moxifloxacin (one 400 mg tablet)
| Study group | Role | What they receive |
|---|---|---|
| Telotristat etiprate | Experimental | Single dose of telotristat etiprate followed by a 7-day washout. Receives: Drug: Telotristat etiprate |
| Moxifloxacin | Active comparator | Single dose of moxifloxacin followed by a 7-day washout. Receives: Drug: Moxifloxacin |
| Placebo | Placebo comparator | Single dose of placebo with a 7-day washout to follow. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline QT interval corrected for heart rate
Measured: Days 1-3
Secondary outcomes (2)
Number of adverse events
Measured: 52 days
Plasma concentration of telotristat etiprate
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QT IntervalStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suman Wason, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155205
- Sponsor's protocol ID
- LX1606.1-105-NRM
- Other IDs
- LX1606.105
- Status last verified
- Sep 2014
- First submitted
- 2 Jun 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Positive Controlled, 3-period, 6-sequence, Crossover Study to Define the Electrocardiogram Effects of a Single Dose of Telotristat Etiprate (LX1606) 1500 mg Compared With Placebo and Open Label Moxifloxacin in Healthy Subjects: A Thorough QT Study
- ClinicalTrials.gov ID
- NCT02155205
- Acronym / sponsor ID
- LX1606.1-105-NRM
- Conditions
- QT Interval
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- First posted
- 4 Jun 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.
The purpose of this study is to demonstrate that telotristat etiprate does not differ from placebo in the mean change from Baseline QT interval corrected for heart rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telotristat etiprate | Experimental | Drug: Telotristat etiprateSingle dose of telotristat etiprate followed by a 7-day washout. |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinSingle dose of moxifloxacin followed by a 7-day washout. |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose of placebo with a 7-day washout to follow. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult males or females ≥18 to ≤55 years of age (inclusive) at the time of Screening
- Body mass index ≥18 to ≤32 kg/m2 at Screening
- Vital signs (after at least 5 minutes resting in a supine position) at Screening which are within the following ranges: Systolic blood pressure 90 to 140 mm Hg, Diastolic blood pressure 50 to 90 mm Hg, heart rate 45 to 100 beats per minute (bpm)
- Clinical laboratory evaluations (including clinical chemistry panel [fasted at least 10 hours], complete blood count, and urinalysis [UA]) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator
- Able to tolerate prolonged periods of quiet, motionless, supervised rest
Key exclusion criteria (9 listed)
- Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator or Sponsor, may interfere with any aspect of study conduct or interpretation of results
- >30 premature ventricular beats per hour on the Holter ECG monitoring at Day -1 of Period 1 (monitored at the clinic via telemetry)
- History of additional risk factors for torsade de pointes or the diagnosis or suggestion of a family history of short QT syndrome or long QT syndrome
- History of renal disease or significantly abnormal kidney function tests
- 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 |
|---|---|---|
| Telotristat etiprate1500 mg telotristat etiprate (six 250 mg tablets) | Drug | Telotristat etiprate |
| PlaceboMatching placebo | Drug | Placebo |
| Moxifloxacin400 mg moxifloxacin (one 400 mg tablet) | Drug | Moxifloxacin |
Primary outcome
Mean change from baseline QT interval corrected for heart rate
Time frame: Days 1-3
2 secondary outcomes
Number of adverse events
Time frame: 52 days
Plasma concentration of telotristat etiprate
Time frame: Day 1
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 8 Sep 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.
Suman Wason, 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 Telotristat etiprate and Moxifloxacin in people with QT Interval, 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 7 inclusion and 9 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 8 Sep 2014. 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. Some participants in this study may receive a placebo. 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?
Mean change from baseline QT interval corrected for heart rate (time frame: Days 1-3). 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 8 Sep 2014.