A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Genz-682452 in Healthy Volunteers

Genzyme

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Placebo; Biological: Genz-682452

Study type: Interventional

Funder types: Industry

Identifiers

NCT01710826

GZFD00311

TDR12768 (Other Identifier)

Details and patient eligibility

About

To assess in healthy adult subjects:

• The tolerability and safety of ascending repeated oral doses of Genz-682452.
• The pharmacokinetic parameters of Genz-682452 after ascending repeated oral doses.
• The pharmacodynamics of Genz-682452 after ascending repeated oral doses.

Enrollment: 36 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight between 50.0 and 95.0 kg, inclusive, if male and between 40.0 and 85.0 kg inclusive, if female, body mass index between 18.0 and 30.0 kg/m^2, inclusive.
• Certified as healthy by a comprehensive clinical assessment.

Exclusion criteria

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
• Blood donation, any volume, within 2 months before inclusion.
• Symptomatic postural hypotension.
• History or presence of drug or alcohol abuse.
• Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
• Positive result on urine drug screen.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

Genz-682452

Experimental group

Description:

This study will include three cohorts for doses of Genz-682452: Dose 1, Dose 2, Dose 3. Each cohort will include 12 participants, 9 of whom will be administered Genz-682452 and 3 will be administered placebo.

Treatment:

Biological: Genz-682452

Placebo

Placebo Comparator group

Description:

Placebo comparator taken by participants randomized to the placebo arm in each of the three cohorts. Each cohort will include 12 participants, 9 of whom will be administered Genz-682452 and 3 will be administered placebo.

Treatment:

Biological: Placebo