10 completed, 2 terminated. 9 Phase 1, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 8, Terminated 1 |
| Phase 3 | 3 | Completed 2, Terminated 1 |
Follow this drug Literature Review of Lu AF35700 trials Research Report on Lu AF35700
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State Lu AF35700, Lu AF35700 iv - Healthy | Phase 1 | Completed | H. Lundbeck A/S | 10 | 2018-09-05 | 2019-11-01 |
| Bioequivalence Study of Lu AF35700 Lu AF35700 5 mg clinical formulation, Lu AF35700 5 mg commercial formulation, Lu AF35700 10 mg clinical formulation - Healthy | Phase 1 | Completed | H. Lundbeck A/S | 87 | 2018-01-03 | 2018-11-29 |
| Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment Lu AF35700 - Renal Failure | Phase 1 | Terminated | H. Lundbeck A/S | 23 | 2017-07-25 | 2019-09-30 |
| Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia Lu AF35700, Risperidone, Olanzapine - Treatment-resistant Schizophrenia | Phase 3 | Terminated | H. Lundbeck A/S | 119 | 2017-07-20 | 2020-01-21 |
| Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes Lu AF35700, Midazolam, Cocktail of CYP450 substrates - Drug Reactions | Phase 1 | Completed | H. Lundbeck A/S | 24 | 2017-06-16 | 2018-01-08 |
| Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects Lu AF35700 - Hepatic Impairment | Phase 1 | Completed | H. Lundbeck A/S | 24 | 2017-05-14 | 2018-05-04 |
| Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women Lu AF35700, Itraconazole (200 mg), Itraconazole (300 mg) - Cytochrome P450 Interaction | Phase 1 | Completed | H. Lundbeck A/S | 22 | 2017-03-28 | 2019-10-02 |
| Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder Lu AF35700 (10 mg/day), Lu AF35700 (30 mg/day), Quetiapine (Seroquel XR® 800 mg/day) - Schizophrenia, Schizoaffective Disorder | Phase 1 | Completed | H. Lundbeck A/S | 119 | 2016-09-01 | 2019-09-12 |
| Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia Lu AF35700 - Schizophrenia | Phase 3 | Completed | H. Lundbeck A/S | 528 | 2016-08-01 | 2020-10-26 |
| Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia Risperidone, Olanzapine, Lu AF35700 - Schizophrenia | Phase 3 | Completed | H. Lundbeck A/S | 1098 | 2016-04-01 | 2019-11-25 |
| Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700 Lu AF35700 - Schizophrenia | Phase 1 | Completed | H. Lundbeck A/S | 22 | 2014-12-30 | 2020-05-12 |
| Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia Lu AF35700, Placebo - Schizophrenia | Phase 1 | Completed | H. Lundbeck A/S | 96 | 2013-01-01 | 2015-03-06 |
Schizophrenia (5) · Drug-Related Side Effects and Adverse Reactions (1) · Psychotic Disorders (1) · Renal Insufficiency (1) · Schizophrenia, Treatment-Resistant (1)
H. Lundbeck A/S (12)
United States (7) · United Kingdom (5) · Bulgaria (3) · Russia (3) · Canada (2) · Czechia (2) · Estonia (2) · Germany (2) · Mexico (2) · Poland (2) · Romania (2) · Serbia (2) · Slovakia (2) · Spain (2) · Ukraine (2)
2016 (3), 2014 (1), 2015 (1), 2017 (1)