Status:
COMPLETED
Pharmacokinetic Study on N-acetylneuraminic Acid
Lead Sponsor:
Tohoku University
Conditions:
Nonaka Myopathy
Hereditary Inclusion Body Myopathy
Eligibility:
All Genders
20-40 years
Phase:
PHASE1
Brief Summary
The aim of this study is to investigate pharmacokinetics and safety of N-acetylneuraminic acid in patients with Distal myopathy with rimmed vacuoles (DMRV) - hereditary inclusion body myopathy (hIBM)....
Eligibility Criteria
Inclusion
- Confirmed mutations in GNE gene
- No severe complications when informed consent is obtained
- More than 40 kg in weight before administration
Exclusion
- Hepatic laboratory parameters (AST, ALT, γ-GTP) or Renal laboratory parameters (Cr, BUN) are greater than three times of upper limit of reference value
- Presence or history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, metabolic, gastrointestinal, brain, psychiatric, neurologic disease
- Intake of supplement contains sialic acid, St. John's wort or grapefruit within 7 days
- Enrollment in another investigational study within 3 months
- More than 400 mL blood donation within 3 months
- Presence of alcohol or drug dependency
- Women who are pregnant , breast feeding or possible to be pregnant.
- Patients whom the investigator judges not to be appropriate for the subject
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01236898
Start Date
November 1 2010
End Date
June 1 2011
Last Update
September 8 2011
Active Locations (1)
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1
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574