HealthyPhase 1NCT02157584
An Open-Label Food Effect Study of Telotristat Etiprate
A Phase 1 study testing Telotristat etiprate in people with Healthy, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial summary
This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single dose telotristat etiprate in the fasted state in healthy adult male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telotristat etiprate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 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 subjects aged ≥18 to ≤55 years of age at screening
- Body mass index ≥18.0 to ≤32.0 kg/m^2
- Acceptable vital signs at Screening: Systolic blood pressure = 90-140 mm Hg, Diastolic blood pressure = 50-90 mm Hg, Heart rate = 40-100 beats per minute
- Able and willing to ingest an entire high fat/high caloric breakfast meal within 30 minutes
- Willingness to adhere to the restrictions outlined in the protocol
- Able to comprehend and sign the Informed Consent Form
Who cannot join
- Presence of any clinically significant physical, laboratory, or ECG finding that may interfere with the study in the opinion of the Investigator
- Use of any medications, herbal tea, energy drink, herbal products, or supplements within 14 days of study start
- Receipt of any investigational agent or study drug within 30 days or 5 half-lives prior to Screening
- Receipt of any protein- or antibody-based therapeutic agent within 3 months prior to Screening
- Prior exposure to telotristat etiprate
- Use of tobacco, smoking cessation products, or nicotine products within 3 months prior to Screening
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- History of major surgery within 6 months prior to Screening
- History of any GI surgery that may induce malabsorption
- History of renal disease, or significantly abnormal glomerular filtration rate (<90 mL/min as calculated using the Cockcroft-Gault equation) at Screening
- History of hepatic disease, or significantly abnormal liver function tests at Screening
- History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or GI abnormality
- History of any active infection within 14 days prior to Screening
- History of alcohol or substance abuse within 2 years prior to Screening
- Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens
- Concurrent conditions that could interfere with safety and/or tolerability measurements
- Donation or loss of >500 mL of blood or blood product within 3 months prior to Screening
- Women who are breastfeeding or are planning to become pregnant during the study
- Positive serum pregnancy test (females only)
- Positive urine screen for selected drugs of abuse and cotinine
- Consumption of alcohol within 48 hours prior to study start
- Consumption of caffeine- and/or xanthine-containing products within 72 hours of study start
- Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange-containing products within 72 hours prior to study start
- Unable or unwilling to communicate or cooperate with the Investigator for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexicon Investigational Site
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Randomized, Single Center, Open Label, 2 Sequence, 2 Period, Crossover Study to Evaluate the Effect of Food on the Single Dose Pharmacokinetics of Telotristat Etiprate (LX1606 Hippurate) in Healthy Male and Female Subjects
This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single dose telotristat etiprate in the fasted state in healthy adult male and female subjects.
- Conditions
- Healthy
- Being tested
- Telotristat etiprate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telotristat etiprateDrug
2 × 250 mg (as free base) telotristat etiprate tablets (fed conditions /high-fat / high caloric meal)
Telotristat etiprateDrug
2 × 250 mg (as free base) telotristat etiprate tablets (fasted conditions)
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) on Day 1 in a fed condition. Days 2 to 5 will be Washout Days. On Day 6, subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) 1 in a fasted condition. Receives: Drug: Telotristat etiprate |
| Treatment B | Experimental | Subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) on Day 1 in a fasted condition. Days 2 to 5 will be Washout Days. On Day 6, subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) 1 in a fed condition. Receives: Drug: Telotristat etiprate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of telotristat ethyl
Measured: Days 1, 2, 3, 6, 7, 8
Plasma concentration of metabolite LP-778902
Measured: Days 1, 2, 3, 6, 7, 8
Secondary outcomes (1)
Number of treatment emergent adverse events
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT02157584
- Sponsor's protocol ID
- LX1606.1-107-NRM
- Other IDs
- LX1606.107
- Status last verified
- Sep 2014
- First submitted
- 4 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
- A Phase 1, Randomized, Single Center, Open Label, 2 Sequence, 2 Period, Crossover Study to Evaluate the Effect of Food on the Single Dose Pharmacokinetics of Telotristat Etiprate (LX1606 Hippurate) in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02157584
- Acronym / sponsor ID
- LX1606.1-107-NRM
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- First posted
- 6 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.
This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single dose telotristat etiprate in the fasted state in healthy adult male and female subjects.
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: Telotristat etiprateSubjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) on Day 1 in a fed condition. Days 2 to 5 will be Washout Days. On Day 6, subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) 1 in a fasted condition. |
| Treatment B | Experimental | Drug: Telotristat etiprateSubjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) on Day 1 in a fasted condition. Days 2 to 5 will be Washout Days. On Day 6, subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) 1 in a fed condition. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult subjects aged ≥18 to ≤55 years of age at screening
- Body mass index ≥18.0 to ≤32.0 kg/m^2
- Acceptable vital signs at Screening: Systolic blood pressure = 90-140 mm Hg, Diastolic blood pressure = 50-90 mm Hg, Heart rate = 40-100 beats per minute
- Able and willing to ingest an entire high fat/high caloric breakfast meal within 30 minutes
- Willingness to adhere to the restrictions outlined in the protocol
Key exclusion criteria (23 listed)
- Presence of any clinically significant physical, laboratory, or ECG finding that may interfere with the study in the opinion of the Investigator
- Use of any medications, herbal tea, energy drink, herbal products, or supplements within 14 days of study start
- Receipt of any investigational agent or study drug within 30 days or 5 half-lives prior to Screening
- Receipt of any protein- or antibody-based therapeutic agent within 3 months prior to Screening
- Prior exposure to telotristat etiprate
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 etiprate2 × 250 mg (as free base) telotristat etiprate tablets (fed conditions /high-fat / high caloric meal) | Drug | Treatment A |
| Telotristat etiprate2 × 250 mg (as free base) telotristat etiprate tablets (fasted conditions) | Drug | Treatment B |
Primary outcome
Plasma concentrations of telotristat ethyl
Time frame: Days 1, 2, 3, 6, 7, 8
Plasma concentration of metabolite LP-778902
Time frame: Days 1, 2, 3, 6, 7, 8
1 secondary outcome
Number of treatment emergent adverse events
Time frame: 10 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 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 in people with Healthy, 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 6 inclusion and 23 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. 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?
Plasma concentrations of telotristat ethyl (time frame: Days 1, 2, 3, 6, 7, 8). 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 8 Sep 2014.