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Nitisinone DDI Study with CYP and OAT Substrates
NCT03103568Phase 1Completed
- Sponsor
- Sobi
- Start
- Mar 2017
- Primary completion
- Jun 2017
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, open-label trial of nitisinone in hereditary tyrosinemia type 1 (HT1) (2 arms), sponsored by Sobi. Primary endpoints: Area under the curve infinity for CYP2C9 (tolbutamide) substrate at 48 hours, Area under the curve infinity for CYP2D6 (metoprolol) substrate at 23 hours and 2 more. Started Mar 2017; status: completed.
02
Drugs
nitisinone
03
Conditions
hereditary tyrosinemia type 1 (HT1)
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