Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00875160
Eligibility Criteria:
Inclusion Criteria:
* Have a confirmed diagnosis of type 1 Gaucher disease with a documented gene mutation;
* Clinically stable and on a stable dose of ERT for at least 2 years before study entry, with no changes to dose level or regimen in the last 6 months;
* Willing to stop ERT for the duration of the study;
* Male or female between the ages of 18 to 65 inclusive;
* All subjects of reproductive potential are required to practice an acceptable method of contraception;
* All subjects must have a body mass index of less than 30; and
* Provide written informed consent to participate in the study.
Exclusion Criteria:
* A clinically significant disease, severe complications from Gaucher disease, or serious intercurrent illness that may preclude participation in the study in the opinion of the Investigator;
* During the screening/wash out period, any clinically significant findings, based on physical exam, medical history review, lab assessment, vital sign assessment and/or other significant finding which would compromise the safety of the subject, or preclude the subject from completing the study as deemed by the Investigator;
* Partial or total splenectomy;
* History of pulmonary hypertension or Gaucher-related lung disease;
* History of allergy or sensitivity to the study drug or any excipients, including any prior serious allergic reaction to iminosugars;
* Screening or Day 1 (before dosing) 12-lead ECG demonstration QTc \>450 msec in males or \>470 in females;
* Pregnant or breast-feeding;
* Current/recent drug or alcohol abuse within the past 12 months;
* Treatment with any investigational product, including investigational forms of ERT, in the 90 days before study entry;
* Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ;
* Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs; or
* Subject is otherwise unsuitable for the study in the opinion of the Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00875160
Study Brief:
Protocol Section:
NCT00875160