Study Intervention Administered Sample Clauses
Study Intervention Administered. Details of ALXN1840 administered in the study are provided in Table 5. Intervention Name ALXN1840 (formerly WTX101) Type Drug Dose Formulation Tablet Unit Dose Strength(s) 15 mg ALXN1840 containing 7.8 mg of tetrathiomolybdic acid Dosage Level(s) Repeat dose 30 mg administered as 2 × 15 mg ALXN1840 tablets for 15 days Route of Administration Oral Use experimental/study intervention IMP and NIMP IMP Sourcing Provided centrally by ▇▇▇▇▇▇▇ Packaging and Labeling The labeling of study intervention will be in compliance with Good Manufacturing Practice specifications, as described in the Rules Governing Medicinal Products in the European Union, Volume 4, annex 13, Investigational Medicinal Products, and any other or local applicable regulations. Sample labels will be submitted to the UK health authorities according to the submission requirements. Current/Former Name(s) or ▇▇▇▇▇(es) Bis-choline tetrathiomolybdate Abbreviations: IMP = investigational medicinal product; NIMP = noninvestigational medicinal product.
Study Intervention Administered. Intervention Name ALXN2050 (formerly ACH-0145228) ALXN2050 (formerly ACH-0145228) Type Drug Drug Dose Formulation Capsule Tablet Unit Dose Strength(s) 60 mg 60 mg Dosage Level(s) 120 mg or 180 mg 120 mg or 180 mg Route of Administration Oral twice daily (bid) Oral twice daily (bid) Use Experimental Experimental IMP/NIMP IMP IMP Sourcing Provided by Sponsor Provided by Sponsor Packaging and Labeling Study medication will be provided in bottles. Each bottle will be labeled as required per country requirement. Study medication will be provided in bottles. Each bottle will be labeled as required per country requirement. Abbreviations: IMP = investigational medicinal product; NIMP = non-investigational medicinal product Details on the formulation of the study medication are provided in the Investigators’ Brochure and Pharmacy Manual.