An Open-label, Non-randomized, 2-arm, 2-period Fixed Sequence Phase 1 Study to Evaluate the Potential Inhibition of Nitisinone on Cytochrome P450 2C9, 2D6, and 2E1 and the Organic Anion Transporters OAT1 and OAT3 in Healthy Volunteers
Phase of Trial: Phase I
Latest Information Update: 15 Nov 2018
At a glance
- Drugs Nitisinone (Primary) ; Chlorzoxazone; Furosemide; Metoprolol; Tolbutamide
- Indications Inborn error metabolic disorders; Tyrosinaemia type I
- Focus Pharmacokinetics
- Sponsors Swedish Orphan Biovitrum
- 15 Nov 2018 Results asseesing pharmacokinetics, safety and tolerability of Nitisinone in healthy volunteers, published in the European Journal of Clinical Pharmacology.
- 09 Aug 2017 Status changed from active, no longer recruiting to completed.
- 21 Jul 2017 Planned End Date changed from 19 Jul 2017 to 25 Jul 2017.