Status:
COMPLETED
Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of AFQ056 in Children With Fragile X Syndrome (FXS)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Fragile X Syndrome
Eligibility:
All Genders
3-11 years
Phase:
PHASE1
Brief Summary
The aim of this study is to characterize the pharmacokinetics and safety/tolerability of AFQ056 in children with Fragile X Syndrome(FXS)
Eligibility Criteria
Inclusion
- Genetically confirmed diagnosis of FXS
- At Screening and first baseline, vital signs, body weight and body mass index (BMI) must be age-specific within normal ranges.
Exclusion
- Use of any other investigational drug within 30 days or 5 half-lives (whichever is longer) of the investigational drug prior to screening until end of study visit.
- History of hypersensitivity to AFQ056 or any mGluR antagonist.
- Female patients who are confirmed or suspected to be sexually active.
- History or presence of any clinically significant disease of any major system organ class, within the past 2 years prior to screening including but not limited to psychiatric, neurological, cardiovascular, endocrine, metabolic, renal, or gastrointestinal disorders (except for typical features of FXS).
- Smokers.
- Loss of ≥10% of total blood volume within 8 weeks (or less if required for this age group and/or by local regulation) prior to dosing or longer if required for this age group and/or by local regulation.
- Significant illness that did not completely resolve at least four weeks prior to the first baseline visit.
- Any abnormal laboratory values at screening or first baseline that are in the opinion of the investigator clinically significant and may jeopardize the safety of the study subject.
- Use of (or use within at least 5 half lives before dosing) concomitant medications that are strong/moderate inhibitors or inducers of CYP1A1/2, CYP2C9/19 or CYP3A4
- History or presence of Hepatitis B/C or HIV at screening
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01482143
Start Date
March 1 2012
End Date
October 1 2013
Last Update
December 8 2020
Active Locations (4)
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1
Novartis Investigative Site
Sacramento, California, United States, 95817
2
Novartis Investigative Site
Chicago, Illinois, United States, 60612
3
Novartis Investigative Site
Nashville, Tennessee, United States, 37232-7548
4
Novartis Investigative Site
Sant Cugat del Vallès, Catalonia, Spain, 08190