Effect of Venglustat in Patients With Renal Impairment
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 3/13/2019 |
| Start Date: | October 5, 2018 |
| End Date: | February 27, 2019 |
A Phase I, Single-Center, Open-label, Single Dose Pharmacokinetic and Tolerability Study of GZ402671 in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
Primary Objective:
To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics
(PK) of Venglustat following a single dose.
Secondary Objective:
To assess the tolerability of Venglustat given as a single dose in subjects with mild,
moderate and severe renal impairment in comparison with matched subjects with normal renal
function.
To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics
(PK) of Venglustat following a single dose.
Secondary Objective:
To assess the tolerability of Venglustat given as a single dose in subjects with mild,
moderate and severe renal impairment in comparison with matched subjects with normal renal
function.
Approximately 41 days, including a 21-day screening period, a 1-day treatment period,
followed by a 9-day period of plasma sampling for assessment of primary endpoints.
followed by a 9-day period of plasma sampling for assessment of primary endpoints.
Inclusion criteria:
For all Subjects:
- Male and/or female subjects, between 18 and 79 years of age, inclusive.
- Body weight between 50.0 and 115.0 kg, inclusive, if male, and between 40.0 and 100.0
kg, inclusive, if female, body mass index between 18.0 and 34.9 kg/m2, inclusive
- Normal electrocardiogram (ECG)
- Having given written informed consent prior to undertaking any study-related procedure
- Not under any administrative or legal supervision
- Male subject, 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 subject, whose partners are pregnant, must use, during sexual intercourse, a
condom from the inclusion up to 4 months after the last dosing
- Male subject has agreed not to donate sperm from the inclusion up to 4 months after
the last dosing
- Female subject must use a double contraception method including a highly effective
method of birth control from at least 30 days prior to the inclusion to 30 days after
the last IMP administration, except if she has undergone sterilization (documented) at
least 3 months earlier or is postmenopausal
Specific for subjects with renal impairment:
- Stable chronic renal impairment
- Vital signs and laboratory parameters within acceptable range for subjects with renal
impairment
Specific for matched healthy subjects:
- Normal renal function
- Certified as healthy by a comprehensive clinical assessment (detailed medical history
and complete physical exam)
- Normal vital signs and laboratory parameters
Exclusion criteria:
- 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, irrespective of the decrease in blood pressure, or
asymptomatic postural hypotension judged clinically relevant by the Investigator
- Any significant change in chronic treatment medication within 14 days before inclusion
- Any drug which could impact by any mechanism of action, the pharmacokinetics of the
investigational medicinal product, including moderate and strong cytochrome P3A
(CYP3A) inhibitors or inducers; 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 plasma alcohol test
- Active hepatitis, hepatic insufficiency
- If female, pregnancy [defined as positive β-Human Chorionic Gonadotropin (β-HCG) blood
test], breast-feeding
Specific for subjects with renal impairment:
- Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal,
metabolic, hematological, neurological, osteomuscular, articular, psychiatric,
systemic, ocular, or infectious disease, or signs of acute illness
- Acute renal failure (de novo or superimposed on preexisting chronic renal impairment),
nephrotic syndrome
- History of or current hematuria of urologic origin that limits the subject's
participation in the study
- Subjects requiring dialysis during the study
Specific for matched healthy controls:
- 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
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
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