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| ID | Type | Description | Link |
|---|---|---|---|
| LX1606.110 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole 40 MG | Drug | Omeprazole 40 mg capsule |
| |
| Famotidine 40 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration of telotristat ethyl | Maximum observed concentration of telotristat ethyl | 7 days |
| Time of maximum observed concentration of telotristat ethyl | Time of maximum observed concentration of telotristat ethyl | 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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Number of adverse events throughout the duration of the study | Up to 13 days |
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Inclusion Criteria:
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.
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suman Wason, MD | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Dallas | Texas | 75247 | United States |
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| Drug |
Famotidine 40 mg tablet |
|
| Telotristat ethyl 250 mg | Drug | Telotristat ethyl 250 mg tablet |
|
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D015738 | Famotidine |
| C000621725 | telotristat ethyl |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013844 | Thiazoles |
| D001393 | Azoles |
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