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

NCT06421714 | Completed Phase 1 FDA Drug

• 2 other identifiers: INT143392014-002550-39
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration versus time curve (AUC) of venglustat

  Multiple time points up to 21 days

• Area under the plasma concentration versus time curve calculated from time zero to the real time (tlast) (AUClast) of venglustat

  Multiple time points up to 21 days

Secondary Outcomes (12)

• Maximum plasma concentration observed (Cmax) of venglustat

  Multiple time points up to 21 days

• Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of venglustat

  Multiple time points up to 21 days

• Time to reach Cmax (tmax) of venglustat

  Multiple time points up to 21 days

• Terminal half-life (t1/2) of venglustat

  Multiple time points up to 21 days

• Maximum plasma concentration observed (Cmax) of itraconazole

  Multiple time points up to 21 days

Study Arms (1)

Venglustat and Itraconazole

EXPERIMENTAL

The first period will include a single dose administration of venglustat followed by a second period including a multiple dose administration of itraconazole for 12 days and a second single dose administration of venglustat on the 6th day of itraconazole administration

Drug: Venglustat; Drug: Itraconazole

Interventions

Venglustat DRUG

Pharmaceutical form:Capsule-Route of administration:Oral

Also known as: GZ/SAR402671

Venglustat and Itraconazole

Itraconazole DRUG

Pharmaceutical form:Capsule-Route of administration:Oral

Also known as: ITZ, Sporanox

Venglustat and Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight between 50.0 and 100.0 kg, inclusive, body mass index between 18.0 and 30.0 kg/m2, inclusive.
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
• Normal vital signs, electrocardiogram, and laboratory parameters.
• Having given written informed consent prior to undertaking any study-related procedure.
• Not under any administrative or legal supervision.

You may not qualify if:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
• Symptomatic postural hypotension excluding vasovagal episode associated with a blood draw.
• Presence or history of clinically significant drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
• History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
• Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled). Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
• Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency Virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
• Positive result on urine drug screen or urine alcohol test.
• Any contraindications to itraconazole, according to the applicable labeling.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (1)

PPD

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

venglustat; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 20, 2024
• Study Start: August 16, 2018
• Primary Completion: October 14, 2018
• Study Completion: October 14, 2018
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)