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

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: August 24, 2012
Last updated: March 17, 2014
Last verified: March 2014

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.

Condition Intervention Phase
Healthy Volunteer
Drug: Genz-682452
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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.

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 63
Study Start Date: August 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 (GZFD00111/TDU12766): Genz-682452
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
Capsules for oral administration.
Placebo Comparator: Part 1 (GZFD00111/TDU12766): Placebo
Participants will receive a single oral dose of placebo.
Drug: Placebo
Placebo to Genz-682452
Experimental: Part 2 (GZFD00211/FED12767): Genz-682452
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.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01674036

United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Genzyme, a Sanofi Company Identifier: NCT01674036     History of Changes
Other Study ID Numbers: GZFD00111/GZFD00211
TDU12766/FED12767 ( Other Identifier: Sanofi Study Number )
Study First Received: August 24, 2012
Last Updated: March 17, 2014 processed this record on May 22, 2017