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

Healthy Volunteer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674036
• Other study ID #: GZFD00111/GZFD00211
• Secondary ID: TDU12766/FED1276
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2012
• Last updated: March 17, 2014
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Genz-682452
Capsules for oral administration.
• Placebo
Placebo to Genz-682452

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events in Part 1		Up to 4 weeks	Yes
Primary	Number of participants with adverse events in Part 2		Up to 5 weeks	Yes
Secondary	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	No
Secondary	Pharmacokinetics Urine Parameters for Part 1 as measured by assessment of Genz-682452 urinary excretion, Ae0-t, fe0-t		Day 1 through Day 5	No
Secondary	Pharmacokinetics Plasma Parameters for Part 2 as measured by Cmax, tmax, tlag, AUC last, AUC, t1/2z		Day 1 to Day 3	No