Two-period, single-dose pharmacokinetic study in male adolescent patients with Fragile X Syndrome (FXS).

• Conditions: Fragile X Syndrome; MedDRA version: 14.0Level: PTClassification code 10017324Term: Fragile X syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-019353-18-Outside-EU/EEA
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: A
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

1. Male patients with FXS aged 12 - 18 years.

2. Confirmed diagnosis of FXS by sequencing (>200 CGG repeats in the fmr1 gene)

3. Absence of cardiovascular, gastrointestinal, renal, orthopedic, neurological or nervous system co-morbidities (excluding FXS symptoms)

4. Body weight and body mass index must be within 10th to 90th percentile of the age-specific range

Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any subject who does not fulfill each of the inclusion criteria

2. Smokers (reported tobacco use within the last 3 months prior to screening and/or urine cotinine =500 ng/mL

3. Significant illness within 2 weeks prior to the screening visit.

4. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs

5. Any use of CYP3A4 inhibitors or inducers within 4 weeks prior to dosing

6. Use of any herbal supplement or over the counter drugs within 4 weeks prior to dosing.

7. Positive HIV or hepatisis B/C

8. History of drug or alcohol abuse within 12 months prior to dosing

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified