Healthy VolunteersPhase 1NCT06421714
A Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered Venglustat and Itraconazole in Healthy Adult Male Participants
A Phase 1 study testing Venglustat and Itraconazole in people with Healthy Volunteers, run by Genzyme, a Sanofi Company at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Venglustat and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2018to 14 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Healthy Volunteers
- Being tested
- Venglustat, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenglustatDrug
Also called GZ/SAR402671
Pharmaceutical form:Capsule-Route of administration:Oral
ItraconazoleDrug
Also called ITZ, Sporanox
Pharmaceutical form:Capsule-Route of administration:Oral
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Venglustat; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of venglustat
Measured: 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
Measured: Multiple time points up to 21 days
Secondary outcomes (12)
Maximum plasma concentration observed (Cmax) of venglustat
Measured: Multiple time points up to 21 days
Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of venglustat
Measured: Multiple time points up to 21 days
Time to reach Cmax (tmax) of venglustat
Measured: Multiple time points up to 21 days
Terminal half-life (t1/2) of venglustat
Measured: Multiple time points up to 21 days
Maximum plasma concentration observed (Cmax) of itraconazole
Measured: Multiple time points up to 21 days
Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of itraconazole
Measured: Multiple time points up to 21 days
Time to reach Cmax (tmax) of itraconazole
Measured: Multiple time points up to 21 days
Area under the plasma concentration versus time curve calculated over the dosing interval (12 h) (AUC0-12) of itraconazole
Measured: Multiple time points up to 21 days
Maximum plasma concentration observed (Cmax) of hydroxyitraconazole
Measured: Multiple time points up to 21 days
Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of hydroxyitraconazole
Measured: Multiple time points up to 21 days
Time to reach Cmax (tmax) of hydroxyitraconazole
Measured: Multiple time points up to 21 days
Area under the plasma concentration versus time curve over the dosing interval (12 h) (AUC0-12) of hydroxyitraconazole
Measured: Multiple time points up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start16 Aug 2018
- Primary completion14 Oct 2018
- Study completion14 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421714
- Sponsor's protocol ID
- INT14339
- Other IDs
- 2014-002550-39, 2014
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06421714
- Acronym / sponsor ID
- INT14339
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 14 Oct 2018 (actual)
- Study completion
- 14 Oct 2018 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venglustat and Itraconazole | Experimental | Drug: Venglustat, Drug: ItraconazoleThe 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenglustatAlso: GZ/SAR402671Pharmaceutical form:Capsule-Route of administration:Oral | Drug | Venglustat and Itraconazole |
| ItraconazoleAlso: ITZ, SporanoxPharmaceutical form:Capsule-Route of administration:Oral | Drug | Venglustat and Itraconazole |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of venglustat
Time frame: 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
Time frame: Multiple time points up to 21 days
12 secondary outcomes
Maximum plasma concentration observed (Cmax) of venglustat
Time frame: Multiple time points up to 21 days
Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of venglustat
Time frame: Multiple time points up to 21 days
Time to reach Cmax (tmax) of venglustat
Time frame: Multiple time points up to 21 days
Terminal half-life (t1/2) of venglustat
Time frame: Multiple time points up to 21 days
Maximum plasma concentration observed (Cmax) of itraconazole
Time frame: Multiple time points up to 21 days
Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of itraconazole
Time frame: Multiple time points up to 21 days
Time to reach Cmax (tmax) of itraconazole
Time frame: Multiple time points up to 21 days
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
Maximum plasma concentration observed (Cmax) of hydroxyitraconazole
Time frame: Multiple time points up to 21 days
Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of hydroxyitraconazole
Time frame: Multiple time points up to 21 days
Time to reach Cmax (tmax) of hydroxyitraconazole
Time frame: Multiple time points up to 21 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: Yes. 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
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Venglustat and Itraconazole in people with Healthy Volunteers, run by Genzyme, a Sanofi Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) of venglustat (time frame: Multiple time points up to 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.