32 completed. 32 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 32 | Completed 32 |
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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 |
|---|---|---|---|---|---|---|
| Relative Bioavailability and Bioequivalence of Opicapone Ongentys, BIA 9-1067 (test) - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 45 | 2019-03-19 | 2020-12-31 |
| Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC) 50 mg BIA 9 1067, 25 mg BIA9 1067, 50 mg Ongentys - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 72 | 2018-02-20 | 2020-02-11 |
| A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa. Opicapone, Carbidopa Levodopa - Parkinson Disease | Phase 1 | Completed | Neurocrine Biosciences | 16 | 2018-02-08 | 2019-03-22 |
| Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone Opicapone (OPC) - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 56 | 2017-06-20 | 2018-10-15 |
| Effect of Food on Opicapone Opicapone (OPC) - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 28 | 2014-11-21 | 2017-04-17 |
| Effect of Opicapone at Steady State on Warfarin Pharmacokinetics BIA 9-1067, Warfarin - Parkinson's Disease | Phase 1 | Completed | Bial - Portela C S.A. | 20 | 2014-03-01 | 2014-12-02 |
| Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers BIA 9-1067, Paracetamol - Parkinson's Disease | Phase 1 | Completed | Bial - Portela C S.A. | 28 | 2014-03-01 | 2015-11-18 |
| Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers BIA 9-1067 (clinical micronized, CM), BIA 9-1067 (to-be-marketed, TBM) - Parkinson | Phase 1 | Completed | Bial - Portela C S.A. | 85 | 2014-03-01 | 2025-03-12 |
| Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone BIA 9-1067 non-micronized, BIA 9-1067 micronized - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 28 | 2014-02-01 | 2015-08-21 |
| Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation BIA 9-1067 - Epilepsy | Phase 1 | Completed | Bial - Portela C S.A. | 56 | 2014-02-01 | 2015-08-21 |
| The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics BIA 9-1067, Entacapone, Placebo - Parkinson's Disease (PD) | Phase 1 | Completed | Bial - Portela C S.A. | 80 | 2011-09-01 | 2016-09-20 |
| Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects BIA 9-1067, Placebo - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 105 | 2011-05-01 | 2016-06-20 |
| An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites OPC - Parkinson's Disease (PD) | Phase 1 | Completed | Bial - Portela C S.A. | 6 | 2011-03-01 | 2015-08-21 |
| Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women BIA 9-1067, Placebo, moxifloxacin - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 64 | 2010-05-01 | 2012-06-21 |
| Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment BIA 9-1067 - Parkinson's Disease | Phase 1 | Completed | Bial - Portela C S.A. | 16 | 2010-03-01 | 2015-01-15 |
| Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics BIA 9-1067 5 mg, BIA 9-1067 25 mg, levodopa/carbidopa 100/25 - Parkinson's Disease (PD) | Phase 1 | Completed | Bial - Portela C S.A. | 74 | 2010-02-01 | 2015-12-24 |
| Effect of Rasagiline on BIA 9-1067 Pharmacokinetics BIA 9-1067, Rasagiline - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 25 | 2009-11-01 | 2015-08-20 |
| Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic BIA 9-1067 5 mg, Entacapone, Placebo - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 82 | 2009-11-01 | 2015-08-20 |
| Effect of BIA 9-1067 on Rasagiline Pharmacokinetics rasagiline, BIA 9-1067 - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 24 | 2009-11-01 | 2015-08-20 |
| Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin BIA 9-1067, Warfarin - Parkinson's Disease (PD) | Phase 1 | Completed | Bial - Portela C S.A. | 20 | 2009-06-01 | 2015-12-22 |
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Parkinson Disease (29) · Epilepsy (1)
Bial - Portela C S.A. (31) · Neurocrine Biosciences (1)
France (9) · Canada (6) · Portugal (4) · United Kingdom (2) · United States (2) · Germany (1) · Netherlands (1) · Russia (1) · Switzerland (1)
Eric Sicard, MD (3) · Manuel Vaz-da-Silva, MD, PhD (2) · Dikran Mouradian, MD (1) · Haejung Marr, MD (1) · Marie-Claude Homery, MD (1) · Nicolas Fauchoux, MD (1) · Patricio Soares-da-Silva, MD, PhD (1) · Seiberling Michael, MD (1)