Safety, Tolerability and Pharmacokinetics of Genz-682452 in Healthy Men

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01674036

Enrollment

Registered

2012-08-28

Start date

2012-08-31

Completion date

2013-01-31

Last updated

2014-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGGenz-682452

Capsules for oral administration.

DRUGPlacebo

Placebo to Genz-682452

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events in Part 1	Up to 4 weeks
Number of participants with adverse events in Part 2	Up to 5 weeks

Secondary

Measure	Time frame
Pharmacokinetics Plasma Parameters for Part 1 as measured by Cmax, tmax, AUC last, AUC, t1/2z, Vss/F, CL/F	Day 1 through Day 5
Pharmacokinetics Urine Parameters for Part 1 as measured by assessment of Genz-682452 urinary excretion, Ae0-t, fe0-t	Day 1 through Day 5
Pharmacokinetics Plasma Parameters for Part 2 as measured by Cmax, tmax, tlag, AUC last, AUC, t1/2z	Day 1 to Day 3

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026