A Phase 1 interventional study of Genz-682452 and Placebo in Healthy Volunteer, sponsored by Genzyme, a Sanofi Company. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-19.
Sponsored by Genzyme, a Sanofi Company · Phase 1, Interventional, and Treatment
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.
Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a single oral dose of Genz-682452. Six ascending single doses and an optional seventh dose under fasted conditions will be used.
Drug: Genz-682452
Participants will receive a single oral dose of placebo.
Drug: Placebo
Participants will receive two single doses of Genz-682452 separated by a 7-day wash-out period, one dose given under fed (standardized high-fat breakfast) and one under fasted conditions. The dose will be based on the blind review of the safety/tolerability/pharmacokinetic data of single dose level cohorts in Part 1.
Drug: Genz-682452
Capsules for oral administration.
Placebo to Genz-682452
Number of participants with adverse events in Part 1
Time frame: Up to 4 weeks
Number of participants with adverse events in Part 2
Time frame: Up to 5 weeks
Pharmacokinetics Plasma Parameters for Part 1 as measured by Cmax, tmax, AUC last, AUC, t1/2z, Vss/F, CL/F
Time frame: Day 1 through Day 5
Pharmacokinetics Urine Parameters for Part 1 as measured by assessment of Genz-682452 urinary excretion, Ae0-t, fe0-t
Time frame: Day 1 through Day 5
Pharmacokinetics Plasma Parameters for Part 2 as measured by Cmax, tmax, tlag, AUC last, AUC, t1/2z
Time frame: Day 1 to Day 3
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Genzyme, a Sanofi Company