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Completed

NCT Number: NCT01674036

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Austin, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Genz-682452

Drug

Capsules for oral administration.

Placebo

Drug

Placebo to Genz-682452

Primary outcomes

  1. Number of participants with adverse events in Part 1

    Time frame: Up to 4 weeks

  2. Number of participants with adverse events in Part 2

    Time frame: Up to 5 weeks

Secondary outcomes

  1. 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

  2. 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

  3. Pharmacokinetics Plasma Parameters for Part 2 as measured by Cmax, tmax, tlag, AUC last, AUC, t1/2z

    Time frame: Day 1 to Day 3

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 28, 2012
Registry last updated
Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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