DeepMed Research

Telotristat

Generic Name: Telotristat

Brand Names: Xermelo

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₂ClF_₃N_₆O_₃

CAS Number: 1033805-28-5

Unique Ingredient Identifier: 381V4FCV2Z

Background: A tryptophan hydroxylase inhibitor. Telotristat ethyl (brand name Xermelo) is a prodrug of telotristat.

Clinical Trials

Telotristat Ethyl for Reducing Intraoperative Carcinoid Crisis in Patients With Neuroendocrine Tumors

Phase 2

Withdrawn

Conditions: Neuroendocrine Tumors

Interventions: Drug: Telotristat Ethyl Oral Tablet

First Posted Date: 2020-12-17

Last Posted Date: 2021-12-17

Lead Sponsor: University of Chicago

Registration Number: NCT04672876

Telotristat With Lutathera in Neuroendocrine Tumors

Phase 2

Terminated

Conditions: Neuroendocrine Tumors

Interventions: Drug: Telotristat (Low-Dose)
Drug: Telotristat (High-Dose)

First Posted Date: 2020-09-10

Last Posted Date: 2023-06-27

Lead Sponsor: Lowell Anthony, MD

Target Recruit Count: 1

Registration Number: NCT04543955

Locations: 🇺🇸
Markey Cancer Center, Lexington, Kentucky, United States

AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm

Phase 2

Completed

Conditions: Carcinoid Syndrome
Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm

Interventions: Other: Carbon C 11 Alpha-methyltryptophan
Other: Laboratory Biomarker Analysis
Procedure: Positron Emission Tomography
Drug: Telotristat Etiprate

First Posted Date: 2018-03-05

Last Posted Date: 2025-04-10

Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Target Recruit Count: 4

Registration Number: NCT03453489

Locations: 🇺🇸
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

Study to Compare a Dose of Telotristat Etiprate in Subjects With Renal Impairment With Matched Subjects With Normal Renal Function

Phase 1

Completed

Conditions: Renal Impairment

Interventions: Drug: Telotristat etiprate

First Posted Date: 2018-02-22

Last Posted Date: 2020-04-08

Lead Sponsor: Ipsen

Target Recruit Count: 16

Registration Number: NCT03442725

Locations: 🇩🇪
CRS Clinical Research Services Kiel GmbH, Kiel, Germany
🇲🇩
ARENSIA Exploratory Medicine Phase I Unit, Republican Clinical Hospital, Chisinau, Moldova, Republic of
🇧🇪
A.T.C. s.a., Clinical Pharmacology Unit, CHU Sart-Tilman, Liège, Belgium

and more 1 locations

A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects

Phase 1

Completed

Conditions: Drug-drug Interaction

Interventions: Drug: Omeprazole 40 MG
Drug: Famotidine 40 mg
Drug: Telotristat ethyl 250 mg

First Posted Date: 2017-10-05

Last Posted Date: 2018-04-25

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 32

Registration Number: NCT03302845

Locations: 🇺🇸
Covance Clinical Research Unit, Dallas, Texas, United States

Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO

Completed

Conditions: Carcinoid Syndrome

Interventions: Drug: Xermelo

First Posted Date: 2017-07-21

Last Posted Date: 2024-07-24

Lead Sponsor: TerSera Therapeutics LLC

Target Recruit Count: 223

Registration Number: NCT03223428

Locations: 🇺🇸
RTI-HS, Research Triangle Park, North Carolina, United States

Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects

Phase 1

Completed

Conditions: Hepatic Impairment

Interventions: Drug: telotristat etiprate

First Posted Date: 2016-02-17

Last Posted Date: 2019-01-25

Lead Sponsor: Ipsen

Target Recruit Count: 24

Registration Number: NCT02683577

Locations: 🇷🇴
ARENSIA Exploratory Medicine, Bucharest, Romania

Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects

Phase 1

Completed

Conditions: Drug Interactions

Interventions: Drug: Telotristat etiprate
Drug: Octreotide acetate

First Posted Date: 2014-07-21

Last Posted Date: 2016-09-07

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 24

Registration Number: NCT02195635

Locations: 🇺🇸
Lexicon Investigational Site, Daytona Beach, Florida, United States

An Open-Label Food Effect Study of Telotristat Etiprate

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Telotristat etiprate

First Posted Date: 2014-06-06

Last Posted Date: 2014-09-08

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 22

Registration Number: NCT02157584

Locations: 🇺🇸
Lexicon Investigational Site, Madison, Wisconsin, United States

An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine in Healthy Subjects

Phase 1

Completed

Conditions: Drug Interactions

Interventions: Drug: Fexofenadine
Drug: Telotristat etiprate

First Posted Date: 2014-06-06

Last Posted Date: 2014-09-08

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 24

Registration Number: NCT02157558

Locations: 🇺🇸
Lexicon Investigational Site, Dallas, Texas, United States

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