Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
110 participants
INTERVENTIONAL
2019-02-06
2019-10-22
Brief Summary
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Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 tablets administered orally to healthy subjects
Stage 3: To assess the safety and tolerability of a single dose of IW-6463 when administered to health subjects in fed vs fasted states and explore the effects of food on IW-6463 pharmacokinetics (PK)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
TRIPLE
Study Groups
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IW-6463
IW-6463 tablets administered orally as single ascending doses, multiple ascending daily doses, and single doses with or without food
IW-6463
IW-6463 Tablet
Placebo
Matching placebo tablets administered orally
Matching Placebo
Matching Placebo Tablet
Interventions
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IW-6463
IW-6463 Tablet
Matching Placebo
Matching Placebo Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is in good health and has no clinically significant findings on physical examination
* Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 3 months after the final dose of study drug
* Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 3 months after the final dose of study drug
Exclusion Criteria
* Use of any prescribed or non-prescribed medication
ALL
Yes
Sponsors
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Tisento Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Chad Glasser, PharmD
Role: STUDY_DIRECTOR
Cyclerion Therapeutics, Inc
Geert J Groeneveld, MSc
Role: PRINCIPAL_INVESTIGATOR
Centre for Human Drug Research
Locations
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Centre for Human Drug Research
Leiden, , Netherlands
Countries
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Other Identifiers
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CY6463
Identifier Type: OTHER
Identifier Source: secondary_id
C6463-101
Identifier Type: -
Identifier Source: org_study_id
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