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A Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered Venglustat and Itraconazole in Healthy Adult Male Participants

NCT06421714 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-05-20

No results posted yet for this study

Summary

The purpose of this study is to assess in healthy adult male participants the effects of itraconazole on the pharmacokinetics of venglustat and to assess the safety and tolerability of venglustat with and without coadministration of itraconazole. The maximum duration for participants from screening is between 32 to 62 days.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Venglustat

Pharmaceutical form:Capsule-Route of administration:Oral

DRUG

Itraconazole

Pharmaceutical form:Capsule-Route of administration:Oral

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-16
Primary Completion
2018-10-14
Completion
2018-10-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06421714 on ClinicalTrials.gov