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COMPLETEDPHASE1

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

A Phase I, Open-label Study to Compare the Pharmacokinetics of Telotristat Ethyl and Its Metabolite in Subjects With Impaired Renal Function to Healthy Subjects With Normal Renal Function After a Single Dose of Telotristat Etiprate

NCT03442725•Ipsen

View on ClinicalTrials.gov

Summary

Renal excretion is a minor elimination route of telotristat etiprate. So this trial is intended to assess the drug behaviour in subjects with decreased renal function. This is a staged study with Part B contingent upon the results of Part A. Part A will enrol a total of 16 subjects, eight with severely impaired renal function and eight healthy subjects. Part B with enrol a total of 16 subjects, eight subjects in each additional renal function group, i.e. mildly impaired renal function group and moderately impaired group.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•All subjects:
•Provision of written informed consent prior to any study related procedure.
•Men and women enrolling in the study must be at least 18 years of age at the time of giving informed consent.
•Women of childbearing potential must agree to use an adequate double-barrier method of contraception during the study and for 30 days after discharge.
•Men must agree to use an adequate, double barrier method of contraception during the study and for 30 days after discharge.
•Additionally, for subjects with renal impaired function:
•Clinical diagnosis of renal impaired function that has been stable for more than 3 months prior to dosing
•Renal impaired function classified as mild, moderate, or severe.
•Under stable medication regimen, i.e. not starting new therapy(ies) or significant changing dosage(s) within at least 1 month prior to dosing, as determined by the investigator.
•Stable and appropriately managed relative to chronic diseases (e.g. diabetes, hypertension) as determined by medical history, physical examination, ECGs, and clinical laboratory tests.
+3 more criteria

Exclusion Criteria

•All subjects:
•Existence of any surgical or medical condition that, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism, or excretion of telotristat etiprate (including bariatric surgery, or any other gastrointestinal surgery, excepting appendectomy and hernia repair, which are acceptable).
•History of any major surgery within six months or anticipated surgery prior to Day-1.
•Patients with hereditary problems of galactose intolerance (lactase deficiency or glucose-galactose malabsorption).
•History of any active infection within 30 days prior to Day-1, if deemed clinically significant by the investigator.
•Positive hepatitis panel results (including hepatitis B surface antigen and hepatitis virus C ribonucleic acid).
•Positive results for human immunodeficiency virus, or who has received diagnosis for acquired immunodeficiency syndrome.
•Positive urine screen for drugs of abuse (not including cotinine).
•Consumption of alcohol within 48 hours prior to Day-1 (as confirmed by alcohol breath screen) and for the duration of the confinement period.
•Smoking more than ten cigarettes per day or equivalent; unable or unwilling to refrain from smoking and tobacco use for two hours prior to dosing and four hours after dose administration.
+12 more criteria

Locations (4)

A.T.C. s.a., Clinical Pharmacology Unit, CHU Sart-Tilman

Liège, Belgium

CRS Clinical Research Services Kiel GmbH

Kiel, Germany

ARENSIA Exploratory Medicine Phase I Unit, Republican Clinical Hospital

Chisinau, Moldova

ARENSIA Unit in Spitalul de Nefrologie

Bucharest, Romania

Key Dates

Start Date

February 9, 2018

Primary Completion Date

April 27, 2018

Completion Date

May 13, 2018

Last Updated

April 8, 2020

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

Telotristat etiprate

DRUG

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

NCT07154901

Renal Impairment

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ACTIVE_NOT_RECRUITINGPHASE1

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

NCT07165015

Renal ImpairmentHealthy+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

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A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure