Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Telotristat Ethyl · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Severe Hepatic Impairment | EXPERIMENTAL | Up to 8 subjects with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15 points) |
| Healthy Control | EXPERIMENTAL | Up to 8 healthy control subjects with normal hepatic function |
| 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 |
|---|---|---|
| Telotristat Ethyl | DRUG | Telotristat ethyl (TE) 250 mg (1 x 250-mg tablet), single dose |
| Omeprazole 40 MG | DRUG | Omeprazole 40 mg capsule |
| Famotidine 40 mg | DRUG | Famotidine 40 mg tablet |
| Telotristat ethyl 250 mg | DRUG | Telotristat ethyl 250 mg tablet |
Inclusion Criteria: * Adult male and female subjects ≥18 to ≤70 years of age, inclusive, at the time of Screening: 1. Females of non-childbearing potential are to be surgically sterile (documented hysterectomy, tubal ligation, or bilateral salpingo-oophorectomy) or postmenopausal (defined as at ...
Telotristat Ethyl is an investigational small molecule being studied for drug-drug interactions and hepatic impairment. It is in Phase 1 clinical development for these gastrointestinal-related conditions. The drug is not approved and remains under investigation.
Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) is developing Telotristat Ethyl. The company is conducting Phase 1 clinical trials to evaluate the drug's effects in healthy subjects and in those with hepatic impairment.
Telotristat Ethyl is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 studies have been completed, both involving healthy volunteers.
Telotristat Ethyl has two completed Phase 1 trials: NCT03302845, studying the effects of omeprazole and famotidine on its absorption in 32 healthy subjects, and NCT03423446, evaluating its pharmacokinetics in 16 subjects with severe hepatic impairment.
Telotristat Ethyl is the ethyl ester prodrug form of telotristat, the active moiety. The drug is being developed by Lexicon Pharmaceuticals for gastrointestinal conditions, with ongoing Phase 1 studies in drug-drug interactions and hepatic impairment.