Exkivity (mobocertinib) / Takeda |
WJOG16022M, jRCT2051220070: Phase Ia/Ib Basket Trial on the safety and efficacy of Mobocertinib in combination with T-DM1 for patients with HER2 mutant solid tumors |
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| Active, not recruiting | 1a/1b | 38 | Japan | | Takeda Pharmaceutical Company Limited | Solid tumors | | | | |
NCT03482453: A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants |
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| Completed | 1 | 69 | US | TAK-788, AP32788, Placebo | Millennium Pharmaceuticals, Inc. | Healthy Volunteers | 12/18 | 01/19 | | |
NCT03811834: A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants |
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| Completed | 1 | 7 | US | Mobocertinib, TAK-788 | Millennium Pharmaceuticals, Inc. | Healthy Volunteers | 03/19 | 03/19 | | |
NCT03928327: A Study to Evaluate Drug-Drug Interaction of TAK-788 With Itraconazole and Rifampin in Healthy Adult Participants |
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| Completed | 1 | 24 | US | TAK-788, Mobocertinib, Itraconazole, Rifampin | Millennium Pharmaceuticals, Inc. | Healthy Volunteers | 08/19 | 08/19 | | |
NCT04441255: A Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics (PK) in Healthy Adult Participants |
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| Completed | 1 | 14 | US | TAK-788, AP32788, Mobocertinib | Takeda | Healthy Volunteers | 08/20 | 08/20 | | |
NCT04051827: Drug-Drug Interaction Study of TAK-788 and Midazolam in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) |
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| Completed | 1 | 26 | Europe, RoW | Midazolam, TAK-788, AP32788 | Millennium Pharmaceuticals, Inc. | Carcinoma, Non-Small-Cell Lung, Lung Neoplasms | 12/20 | 12/21 | | |
NCT03807778: A Study of Mobocertinib in Japanese Adults With Non-Small Cell Lung Cancer |
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| Active, not recruiting | 1 | 53 | Japan | Mobocertinib, TAK-788, AP32788 | Takeda | Non-Small Cell Lung Cancer | 11/21 | 03/25 | | |
NCT04056468: A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function |
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| Completed | 1 | 24 | US | Mobocertinib, AP32788, TAK-788 | Millennium Pharmaceuticals, Inc. | Hepatic Impairment, Healthy Volunteers | 02/22 | 02/22 | | |
NCT04056455: A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys |
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| Completed | 1 | 26 | US | Mobocertinib, TAK-788, AP32788 | Millennium Pharmaceuticals, Inc. | Renal Impairment, Healthy Volunteers | 04/22 | 04/22 | | |