Clinical trial NCT01674036: Safety, Tolerability and Pharmacokinetics of Genz-682452 in Healthy Men
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single Oral Doses of Genz-682452 With a Pilot Investigation of Food Effect in Healthy Adult Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-08-28
Enrollment: 63
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to assess the tolerability, safety and pharmacokinetic parameters of Genz-682452 in healthy adult males, in two parts.

Part 1 (GZFD00111TDU12766): double-blind, randomized, placebo-controlled, sequential ascending single dose study;

Part 2 (GZFD00211FED12767): open-label, randomized, 2-sequence, 2-period, 2-treatment crossover study with a minimum wash-out period; to obtain preliminary information on the pharmacokinetics, tolerability and safety of Genz-682452 after single oral doses in fed and fasted conditions.

Subjects are not allowed to participate in more than 1 part of the study.


Eligibility criteria: Inclusion Criteria:

* Body weight between 50.0 and 100.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m\^2, inclusive.
* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).

Exclusion Criteria:

* 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.
* Blood donation, greater than 100 mL, within 2 months before inclusion.
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
* History or presence of drug or alcohol abuse.
* Unable to stop smoking cigarettes during the study.
* Excessive consumption of beverages containing xanthine bases.

Primary outcomes:
measure: Number of participants with adverse events in Part 1
timeFrame: Up to 4 weeks
measure: Number of participants with adverse events in Part 2
timeFrame: Up to 5 weeks
Secondary outcomes:
measure: Pharmacokinetics Plasma Parameters for Part 1 as measured by Cmax, tmax, AUC last, AUC, t1/2z, Vss/F, CL/F
timeFrame: Day 1 through Day 5
measure: Pharmacokinetics Urine Parameters for Part 1 as measured by assessment of Genz-682452 urinary excretion, Ae0-t, fe0-t
timeFrame: Day 1 through Day 5
measure: Pharmacokinetics Plasma Parameters for Part 2 as measured by Cmax, tmax, tlag, AUC last, AUC, t1/2z
timeFrame: Day 1 to Day 3
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Peterschmitt MJ, Crawford NPS, Gaemers SJM, Ji AJ, Sharma J, Pham TT. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Oral Venglustat in Healthy Volunteers. Clin Pharmacol Drug Dev. 2021 Jan;10(1):86-98. doi: 10.1002/cpdd.865. Epub 2020 Aug 26.