Interventional, Open-label, One-sequence Crossover Study Evaluating the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics, Safety and Tolerability of Lu AF35700 in Healthy Young Men and Women
Phase of Trial: Phase I
Latest Information Update: 19 Nov 2018
At a glance
- Drugs LU AF-35700 (Primary) ; Itraconazole
- Indications Schizoaffective disorder; Schizophrenia
- Focus Pharmacokinetics
- Sponsors Lundbeck A/S
- 05 Nov 2018 Planned End Date changed from 1 Sep 2018 to 1 Apr 2019.
- 05 Nov 2018 Planned primary completion date changed from 1 Sep 2018 to 1 Apr 2019.
- 07 Mar 2018 Planned number of patients changed from 28 to 23.