Trials / Completed
CompletedNCT01874028
A Phase 1 Study to Assess the Effects in the Body of a Single Dose of Trientine Dihydrochloride in Wilson's Disease Patients
A Phase 1 Pharmacokinetic Profiling Study in Patients Receiving Trientine Dihydrochloride for the Treatment of Wilson's Disease.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Univar BV · Industry
- Sex
- All
- Age
- 6 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the effects of a single dose of trientine in children ≥6 years and adult patients with Wilson's disease.
Detailed description
An open, single-dose study to determine the pharmacokinetics, and safety of oral administration of trientine dihydrochloride in both children and adult patients with Wilson's Disease. Blood samples will be taken pre-dose and at 10 time-points post-dose to investigate the pharmacokinetic profile of trientine dihydrochloride up to 12 hours after intake of study medication in 20 patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | trientine dihydrochloride | Patients will take their normal prescribed dose (x1) of trientine dihydrochloride 300mg |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2014-03-01
- Completion
- 2014-03-01
- First posted
- 2013-06-10
- Last updated
- 2014-09-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01874028. Inclusion in this directory is not an endorsement.