A Study of the Safety, Tolerability, and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants

NCT06418607 | Completed Phase 1 FDA Drug

• 2 other identifiers: BEQ15920U1111-1239-0220
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the bioequivalent effect of venglustat in tablet and hard capsule form when give with water under fasting conditions. Also, to evaluate the safety and tolerability of a single dose tablet and hard capsule of venglustat (swallowed whole) under fasting conditions in healthy adult participants. The maximum duration for participants from screening is up to 47 days.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum plasma concentration observed (Cmax) of venglustat

  Multiple time points up to day 16

• 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 day 16

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

  Multiple time points up to day 16

Secondary Outcomes (6)

• Number of participants with adverse events

  Multiple time points up to day 47

• Time to reach Cmax (tmax) of venglustat

  Multiple time points up to day 16

• Interval between administration time and the sampling time preceding the first concentration above the limit of quantification (tlag) of venglustat

  Multiple time points up to day 16

• Terminal half-life associated with the terminal slope (λz) (t1/2z) of venglustat

  Multiple time points up to day 16

• Apparent total body clearance of a drug from the plasma (CL/F) of venglustat

  Multiple time points up to day 16

Study Arms (2)

Sequence 1

EXPERIMENTAL

Venglustat hard capsule administered in period 1 followed by tablet administered in period 2.

Drug: Venglustat

Sequence 2

EXPERIMENTAL

Venglustat tablet administered in period 1 followed by hard capsule administered in period 2.

Drug: Venglustat

Interventions

Venglustat DRUG

Pharmaceutical form:Tablet-Route of administration:Oral

Also known as: GZ/SAR402671

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
• Vital signs after 10 minutes resting in supine position within the following ranges:
• mmHg \< systolic blood pressure (SBP) \<140 mmHg,
• mmHg \< diastolic blood pressure (DBP) \<90 mmHg,
• bpm \< heart rate (HR) \<100 bpm.
• Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges; 120 ms \< PR \<220 ms, QRS \<120 ms, QTc ≤450 ms (Fridericia algorithm recommended), 45bpm \< HR \<100 bpm and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
• Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for healthy participant. Serum creatinine, hepatic transaminases (aspartate aminotransferase, alanine aminotransferase), and alkaline phosphatase should not exceed 1.25X the upper laboratory norm. Total biluribin out of normal range can be acceptable if total bilirubin does not exceed 1.5 the upper limit with normal conjugated bilirubin values (unless the participant has documented Gilbert syndrome).
• Having given written informed consent prior to undertaking any study-related procedure.
• Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
• Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

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, gynecologic (if female), 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).
• 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). Note that 12 fluid ounces of regular beer, 5 fluid ounces of wine, and 1.5 fluid ounces of distilled spirits each contain approximately 14 g of alcohol.
• Smoking regularly more than approximately 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).
• If female, pregnancy (defined as positive β-HCG test) or breast-feeding.
• Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
• Any participant who cannot be contacted in case of emergency.
• Any participant who is the Investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study, or any person dependent (employees or immediate family members) on the study site, the investigator or the sponsor.
• Prisoners or participant who are legally institutionalized.
• 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-HIV-1 and anti HIV-2 Ab).
• Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
• Positive alcohol test.
• Any participant who cannot comply with the following study restrictions: refraining from drinking alcohol, tea, coffee, chocolate, quinine, or caffeine-containing beverages from 1 day before institutionalization and throughout the study duration; not smoking or using tobacco from 1 day prior to institutionalization throughout the study duration until the end of-study visit; following a stable lifestyle with no intensive physical activity from 1 day prior to institutionalization throughout the study duration until the end-of-study visit.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Clinical Pharmacology of Miami Site Number : 8400001

Miami, Florida, 33014, United States

Location

Prism Research Site Number : 8400002

Saint Paul, Minnesota, 55144, United States

Location

MeSH Terms

Interventions

venglustat

Study Design

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

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: June 23, 2020
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)