A Phase 1 Study to Assess the Effects in the Body of a Single Dose of Trientine Dihydrochloride in Wilson's Disease Patients

Sponsor
Univar BV
Study ID
NCT01874028
Phase
PHASE1
Status
Completed

Conditions

  • Wilson's Disease

Eligibility Criteria

Sex
ALL
Age
6 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

To evaluate the effects of a single dose of trientine in children ≥6 years and adult patients with Wilson's disease.

Key Dates

First listed
Jun 10, 2013
Start date
May 31, 2013
Status verified
Sep 2014
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trientine dihydrochloride

Primary Outcome Measure

Pharmacokinetic measurements [ Time Frame: Evaluation of PK parameters will occur at 11 time points:Pre-dose), and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours post-dose ]

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