NCT01236898

Pharmacokinetic Study on N-acetylneuraminic Acid

Pharmacokinetic Study on N-acetylneuraminic Acid in Patients With Distal Myopathy With Rimmed Vacuoles (DMRV) - Hereditary Inclusion Body Myopathy (hIBM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Tohoku University · Academic / Other
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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). Dosages are 800mg single and three times a day and 800mg 3 times a day for 5 consecutive days. N-acetylneuraminic acid and N-glycolylneuraminic acid in serum and urine are measured before and after oral administration of N-acetylneuraminic acid.

Conditions

• Nonaka Myopathy
• Hereditary Inclusion Body Myopathy

Interventions

Type	Name	Description
DRUG	NPC-09	NPC-09 tablet NPC-09 contains 50mg or 100mg N-acetylneuraminic acid (anhydride)

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-11-09
• Last updated: 2011-09-08

Locations

1 site across 1 country: Japan