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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06421714
• Other study ID #: INT14339
• Secondary ID: 2014-002550-39
• Status: Completed
• Phase: Phase 1
• Start date: August 16, 2018
• Est. completion date: October 14, 2018

Study information

• Verified date: May 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 14, 2018
• Est. primary completion date: October 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Venglustat
Pharmaceutical form:Capsule-Route of administration:Oral
• Itraconazole
Pharmaceutical form:Capsule-Route of administration:Oral

Locations

Country	Name	City	State
United States	PPD	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC) of venglustat		Multiple time points up to 21 days
Primary	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	Maximum plasma concentration observed (Cmax) of venglustat		Multiple time points up to 21 days
Secondary	Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of venglustat		Multiple time points up to 21 days
Secondary	Time to reach Cmax (tmax) of venglustat		Multiple time points up to 21 days
Secondary	Terminal half-life (t1/2) of venglustat		Multiple time points up to 21 days
Secondary	Maximum plasma concentration observed (Cmax) of itraconazole		Multiple time points up to 21 days
Secondary	Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of itraconazole		Multiple time points up to 21 days
Secondary	Time to reach Cmax (tmax) of itraconazole		Multiple time points up to 21 days
Secondary	Area under the plasma concentration versus time curve calculated over the dosing interval (12 h) (AUC0-12) of itraconazole		Multiple time points up to 21 days
Secondary	Maximum plasma concentration observed (Cmax) of hydroxyitraconazole		Multiple time points up to 21 days
Secondary	Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of hydroxyitraconazole		Multiple time points up to 21 days
Secondary	Time to reach Cmax (tmax) of hydroxyitraconazole		Multiple time points up to 21 days
Secondary	Area under the plasma concentration versus time curve over the dosing interval (12 h) (AUC0-12) of hydroxyitraconazole		Multiple time points up to 21 days