## Protocol Section
### Identification Module
**NCT ID:** NCT06421714

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

**Official Title:** A Phase I, Single-Center, Open-Label, Two-Period, Single Sequence, Two Treatment Drug-Drug Interaction Study of GZ/SAR402671 (Venglustat) and Itraconazole in Healthy Male Subjects

#### Organization Study ID Info
**ID:** INT14339
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**ID:** 2014-002550-39
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2018-10-14

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-10-14

**Type:** ACTUAL

#### Start Date
**Date:** 2018-08-16

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Genzyme, a Sanofi Company

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** Total study duration for participants is up to 62 days including screening up to 28 days, 1 day of treatment in period 1, washout of 7 days, 13 days of treatment in period 2, and follow up period 10-14 days after last dose.

### Conditions Module

**Conditions:**

- Healthy Volunteers

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 8

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Drug: Venglustat

- Drug: Itraconazole

**Label:** Venglustat and Itraconazole

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Venglustat and Itraconazole

**Description:** Pharmaceutical form:Capsule-Route of administration:Oral

**Name:** Venglustat

**Other Names:**

- GZ/SAR402671

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Venglustat and Itraconazole

**Description:** Pharmaceutical form:Capsule-Route of administration:Oral

**Name:** Itraconazole

**Other Names:**

- ITZ

- Sporanox

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Area under the plasma concentration versus time curve (AUC) of venglustat

**Time Frame:** Multiple time points up to 21 days

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

**Time Frame:** Multiple time points up to 21 days

#### Secondary Outcomes

**Measure:** Maximum plasma concentration observed (Cmax) of venglustat

**Time Frame:** Multiple time points up to 21 days

**Measure:** Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of venglustat

**Time Frame:** Multiple time points up to 21 days

**Measure:** Time to reach Cmax (tmax) of venglustat

**Time Frame:** Multiple time points up to 21 days

**Measure:** Terminal half-life (t1/2) of venglustat

**Time Frame:** Multiple time points up to 21 days

**Measure:** Maximum plasma concentration observed (Cmax) of itraconazole

**Time Frame:** Multiple time points up to 21 days

**Measure:** Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of itraconazole

**Time Frame:** Multiple time points up to 21 days

**Measure:** Time to reach Cmax (tmax) of itraconazole

**Time Frame:** Multiple time points up to 21 days

**Measure:** Area under the plasma concentration versus time curve calculated over the dosing interval (12 h) (AUC0-12) of itraconazole

**Time Frame:** Multiple time points up to 21 days

**Measure:** Maximum plasma concentration observed (Cmax) of hydroxyitraconazole

**Time Frame:** Multiple time points up to 21 days

**Measure:** Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of hydroxyitraconazole

**Time Frame:** Multiple time points up to 21 days

**Measure:** Time to reach Cmax (tmax) of hydroxyitraconazole

**Time Frame:** Multiple time points up to 21 days

**Measure:** Area under the plasma concentration versus time curve over the dosing interval (12 h) (AUC0-12) of hydroxyitraconazole

**Time Frame:** Multiple time points up to 21 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria: -Male participants, between 18 and 55 years of age, inclusive.

* 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.
* Male participant, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (spermicide or intra-uterine device or hormonal contraceptive) from the inclusion up to 4 months after the last dosing.
* Male participant, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing.
* Male participant has agreed not to donate sperm from the inclusion up to 4 months after the last dosing. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
* 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).
* Blood donation, any volume, within 2 months before inclusion.
* 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).
* Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
* 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.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Austin

**Country:** United States

**Facility:** PPD

**State:** Texas

**Zip:** 78744

### IPD Sharing Statement Module

**Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

**IPD Sharing:** YES

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000935

- Term: Antifungal Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000058888

- Term: 14-alpha Demethylase Inhibitors

- ID: D000065607

- Term: Cytochrome P-450 Enzyme Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000065088

- Term: Steroid Synthesis Inhibitors

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000065692

- Term: Cytochrome P-450 CYP3A Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M20133

- Name: Itraconazole

- Relevance: HIGH

- As Found: Part A

- ID: M349697

- Name: Venglustat

- Relevance: HIGH

- As Found: Intelligibility

- ID: M256158

- Name: Hydroxyitraconazole

- Relevance: LOW

- As Found: Unknown

- ID: M6252

- Name: Clotrimazole

- Relevance: LOW

- As Found: Unknown

- ID: M11796

- Name: Miconazole

- Relevance: LOW

- As Found: Unknown

- ID: M4254

- Name: Antifungal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M30537

- Name: Cytochrome P-450 Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M30564

- Name: Cytochrome P-450 CYP3A Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017964

- Term: Itraconazole

- ID: C000608118

- Term: Venglustat

### Misc Info Module

- Version Holder: 2024-05-31
