Drug-drug InteractionPhase 1NCT03302845
A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects
A Phase 1 study testing Omeprazole 40 MG, Famotidine 40 mg and Telotristat ethyl 250 mg in people with Drug-drug Interaction, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial summary
This drug-drug interaction study will evaluate the impact of two different acid reducing agents (from two different drug classes) co-administered with a single dose of telotristat ethyl. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interaction
- What is being tested?
- Omeprazole 40 MG, Famotidine 40 mg and Telotristat ethyl 250 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 7 Nov 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult males or females ≥18 to ≤ 65 years of age at the time of Screening:
- Females of non-childbearing potential are to be surgically sterile (documented hysterectomy, tubal ligation, or bilateral salpingo-oophorectomy) or postmenopausal (defined as at least 12 months of spontaneous amenorrhea). Females of childbearing potential must agree to use an adequate method of contraception during the study from CRU admission through Safety Follow-up. Adequate methods of contraception for subjects or partner include condom, diaphragm, or cervical cap used in conjunction with spermicidal gel, foam, cream, film, or suppository. Hormonal contraception is NOT acceptable in this study. If necessary, follicle-stimulating hormone (FSH) results >40 IU/L at Screening are confirmatory in the absence of a clear postmenopausal history.
- Nonsterile male subjects with sexual partners of childbearing potential must agree to use adequate methods of contraception from CRU admission through Safety Follow-up. Adequate methods of contraception for subjects or partner include the following: condom with spermicidal gel, diaphragm with spermicidal gel, coil (intrauterine device), surgical sterilization, vasectomy, oral contraceptive pill, depo-progesterone injections, progesterone implant (ie, Implanon®), NuvaRing®, Ortho Evra®; if a subject is not sexually active, but becomes active, he or his partner should use medically accepted forms of contraception.
- Body mass index ≥18.0 to ≤32.0 kg/m2 at Screening and Baseline/predose Day 1
- Willing to adhere to the prohibitions and restrictions specified in this protocol
- Able to comprehend and willing to sign an informed consent form (ICF)
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- All laboratory values at Screening and CRU admission fall within normal range or are evaluated as not clinically significant (NCS) by the Investigator if outside normal range.
- Has no clinically meaningful abnormal findings during Screening and CRU admission physical examination, Screening and Baseline ECG, or Screening and Baseline vital signs
- Has the ability to understand and communicate the requirements of the study and is willing to comply with all study procedures
- Has not consumed and agrees to abstain from taking any dietary supplements, herbal products (eg, St. John's wort, garlic, or milk thistle), over-the-counter medications (OTC), supratherapeutic doses of vitamins, or prescription drugs (except as authorized by the Investigator AND Medical Monitor) from 14 days prior to CRU admission through the Safety Follow-up Visit
- Has not consumed alcohol-containing beverages for 3 days prior to CRU admission (as confirmed by alcohol breath analyzer) and agrees not to consume alcohol through the Safety Follow-up Visit
- Has not used tobacco- and/or nicotine-containing products within 60 days prior to the CRU admission and agrees to abstain from using tobacco- and/or nicotine-containing products, including e-cigarettes, through the Safety Follow-up Visit
Who cannot join
- History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or gastrointestinal (GI) abnormality
- Participation in another investigational study within 30 days of CRU admission
- Receipt of any protein- or antibody-based therapeutic agents (eg, growth hormones or monoclonal antibodies) within 3 months prior to Screening. Note: Influenza vaccine will be allowed if administered >21 days prior to CRU admission.
- Prior exposure to TE
- History of any serious adverse reaction or hypersensitivity to any inactive component of TE (ie, microcrystalline cellulose, croscarmellose sodium [disintegrant], talc, silicone dioxide, and magnesium stearate [non-bovine]), unless reaction is deemed irrelevant to the study by the Investigator and Sponsor
- History of malabsorption, bariatric surgery, gastric surgery, cholecystectomy, short-bowel syndrome, or GI surgery that may induce malabsorption
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- History of any serious adverse reaction or hypersensitivity to any component of OMP or FTE
- History of any active infection within 14 days prior to first drug administration, if deemed clinically significant by the Investigator and/or Sponsor
- Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens
- Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of TE (appendectomy and hernia repair are acceptable)
- Concurrent conditions that could interfere with safety and/or tolerability measurements
- Subject has donated plasma within 7 days of first drug administration.
- Subject has donated 1 or more pints of blood (or equivalent blood loss) within 30 days prior to first drug administration.
- Women who are breastfeeding or are planning to become pregnant during the study
- eGFR ≤ 89 ml/min/1.73 m2
- Positive pregnancy test (females only)
- Positive urine screen for selected drugs of abuse and cotinine at Screening or CRU admission
- Consumption of caffeine- and/or xanthine-containing products (cola, coffee, tea, chocolate, etc.) within 72 hours prior to CRU admission (Day 0) and throughout the study
- Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange-containing products within 72 hours prior to CRU admission (Day 0) and throughout the study
- Need for dietary restrictions, unless the restrictions are approved by the Investigator and Sponsor
- Inability or difficulty swallowing whole tablets
- Poor venous access as defined by the Investigator or a designee
- Any other condition that compromises the ability of the subject to provide informed consent or to comply with the objectives and procedures of this protocol, as judged by the Investigator or medical monitor
- Unable or unwilling to communicate or cooperate with the Investigator for any reason
- Employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Parallel Group, Drug-drug Pharmacokinetic Interaction Study to Evaluate the Effects of Multiple-dose Omeprazole and Famotidine on the Absorption of Single-dose Telotristat Ethyl in Healthy Male and Female Subjects
This drug-drug interaction study will evaluate the impact of two different acid reducing agents (from two different drug classes) co-administered with a single dose of telotristat ethyl.
- Conditions
- Drug-drug Interaction
- Being tested
- Omeprazole 40 MG, Famotidine 40 mg, Telotristat ethyl 250 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole 40 MGDrug
Omeprazole 40 mg capsule
Famotidine 40 mgDrug
Famotidine 40 mg tablet
Telotristat ethyl 250 mgDrug
Telotristat ethyl 250 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole | Experimental | Subjects will receive one 40 mg omeprazole capsule per day for 4 days and one 250 mg telotristat ethyl tablet on two separate occasions. Receives: Drug: Omeprazole 40 MG; Drug: Telotristat ethyl 250 mg |
| Famotidine | Experimental | Subjects will receive one 40 mg famotidine tablet given twice daily for 4 days and one 250 mg telotristat ethyl tablet on two separate occasions. Receives: Drug: Famotidine 40 mg; Drug: Telotristat ethyl 250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration of telotristat ethyl
Maximum observed concentration of telotristat ethyl
Measured: 7 days
Time of maximum observed concentration of telotristat ethyl
Time of maximum observed concentration of telotristat ethyl
Measured: 7 days
Area under the plasma concentration-time curve beginning from the first dose until the last quantifiable concentration of telotristat ethyl
Area under the plasma concentration-time curve beginning from the first dose until the last quantifiable concentration of telotristat ethyl
Measured: 7 days
Secondary outcomes (1)
Number of adverse events
Number of adverse events throughout the duration of the study
Measured: Up to 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start21 Sep 2017
- Primary completion23 Oct 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-drug InteractionStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT03302845
- Sponsor's protocol ID
- LX1606.1-110-NRM
- Other IDs
- LX1606.110
- Status last verified
- Apr 2018
- First submitted
- 2 Oct 2017
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Parallel Group, Drug-drug Pharmacokinetic Interaction Study to Evaluate the Effects of Multiple-dose Omeprazole and Famotidine on the Absorption of Single-dose Telotristat Ethyl in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03302845
- Acronym / sponsor ID
- LX1606.1-110-NRM
- Conditions
- Drug-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 5 Oct 2017 (actual)
- 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 drug-drug interaction study will evaluate the impact of two different acid reducing agents (from two different drug classes) co-administered with a single dose of telotristat ethyl.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeprazole | Experimental | Drug: Omeprazole 40 MG, Drug: Telotristat ethyl 250 mgSubjects will receive one 40 mg omeprazole capsule per day for 4 days and one 250 mg telotristat ethyl tablet on two separate occasions. |
| Famotidine | Experimental | Drug: Famotidine 40 mg, Drug: Telotristat ethyl 250 mgSubjects will receive one 40 mg famotidine tablet given twice daily for 4 days and one 250 mg telotristat ethyl tablet on two separate occasions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy adult males or females ≥18 to ≤ 65 years of age at the time of Screening:
- Body mass index ≥18.0 to ≤32.0 kg/m2 at Screening and Baseline/predose Day 1
- Willing to adhere to the prohibitions and restrictions specified in this protocol
- Able to comprehend and willing to sign an informed consent form (ICF)
- All laboratory values at Screening and CRU admission fall within normal range or are evaluated as not clinically significant (NCS) by the Investigator if outside normal range.
Key exclusion criteria (25 listed)
- History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or gastrointestinal (GI) abnormality
- Participation in another investigational study within 30 days of CRU admission
- Receipt of any protein- or antibody-based therapeutic agents (eg, growth hormones or monoclonal antibodies) within 3 months prior to Screening. Note: Influenza vaccine will be allowed if administered >21 days prior to CRU admission.
- Prior exposure to TE
- History of any serious adverse reaction or hypersensitivity to any inactive component of TE (ie, microcrystalline cellulose, croscarmellose sodium [disintegrant], talc, silicone dioxide, and magnesium stearate [non-bovine]), unless reaction is deemed irrelevant to the study by the Investigator and Sponsor
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 |
|---|---|---|
| Omeprazole 40 MGOmeprazole 40 mg capsule | Drug | Omeprazole |
| Famotidine 40 mgFamotidine 40 mg tablet | Drug | Famotidine |
| Telotristat ethyl 250 mgTelotristat ethyl 250 mg tablet | Drug | Famotidine, Omeprazole |
Primary outcome
Maximum observed concentration of telotristat ethyl
Time frame: 7 days
Maximum observed concentration of telotristat ethyl
Time of maximum observed concentration of telotristat ethyl
Time frame: 7 days
Time of maximum observed concentration of telotristat ethyl
Area under the plasma concentration-time curve beginning from the first dose until the last quantifiable concentration of telotristat ethyl
Time frame: 7 days
Area under the plasma concentration-time curve beginning from the first dose until the last quantifiable concentration of telotristat ethyl
1 secondary outcome
Number of adverse events
Time frame: Up to 13 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 25 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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 Omeprazole 40 MG, Famotidine 40 mg and Telotristat ethyl 250 mg in people with Drug-drug Interaction, 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 12 inclusion and 25 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 25 Apr 2018. 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?
Maximum observed concentration of telotristat ethyl (time frame: 7 days). The study lists 3 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 25 Apr 2018.