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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03302845
Other study ID # LX1606.1-110-NRM
Secondary ID LX1606.110
Status Completed
Phase Phase 1
First received October 2, 2017
Last updated April 23, 2018
Start date September 21, 2017
Est. completion date November 7, 2017

Study information

Verified date April 2018
Source Lexicon Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Omeprazole 40 MG
Omeprazole 40 mg capsule
Famotidine 40 mg
Famotidine 40 mg tablet
Telotristat ethyl 250 mg
Telotristat ethyl 250 mg tablet

Locations

Country Name City State
United States Covance Clinical Research Unit Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum observed concentration of telotristat ethyl Maximum observed concentration of telotristat ethyl 7 days
Primary Time of maximum observed concentration of telotristat ethyl Time of maximum observed concentration of telotristat ethyl 7 days
Primary 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
Secondary Number of adverse events Number of adverse events throughout the duration of the study Up to 13 days
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