Women and men with partners of childbearing potential must take effective contraception while on study and women of childbearing potential must have a negative pregnancy test and be non-lactating at screening
Inability to swallow oral medications or presence of GI disorder deemed to jeopardize intestinal absorption of Cu(II)ATSM
Dependence of mechanical ventilation (non-invasive or invasive) for any part of day or night
Exposure to any other investigational agent within 3 months or two investigational agents within 6 months prior to screening visit
Active GI disease (except gastrointestingal reflux disease) within 30 days of screening visit
Known immune compromising illness or treatment
Presence of any of the following clinical conditions
drug abuse or alcoholism
unstable cardiac, pulmonary, renal, hepatic, endocrine or hematologic disorder
active infectious disease
AIDS or AIDS-related complex
unstable psychiatric illness, defined as psychosis or untreated major depression within 90 days of screening visit
neuromuscular disease other than ALS/MND
Dementia that may affect either outcome measures or patient understanding and/or compliance with study requirements and procedures
Use of anticoagulants at therapeutic doses within 7 days prior to screening visit
Current use of strong inducers or inhibitors of CYPs 2C19 and 2D6
All locations for NCT02870634
Sydenham, New South Wales, Australia, 2109
Calvary Health Care Bethlehem
Caulfield, Victoria, Australia, 3162
View full eligibility
Tris trial is registered with FDA with number: NCT02870634. The sponsor of the trial is Collaborative Medicinal Development Pty Limited and it is looking for 50 volunteers for the current phase.
Official trial title: A Phase 1 Single and Multiple Dose Escalation and Pharmacokinetic Study of Cu(II)ATSM Administered Orally to Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease
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