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Trial record 1 of 3 for:    Iw-6463
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A Study of IW-6463 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03856827
Recruitment Status : Completed
First Posted : February 27, 2019
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Cyclerion Therapeutics

Study Description
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Brief Summary:

Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects

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)


Condition or disease Intervention/treatment Phase
Other Drug: IW-6463 Drug: Matching Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of IW-6463 When Administered to Healthy Volunteers as Single Ascending Doses, as Multiple Ascending Doses, and Under Fed Versus Fasting Conditions
Actual Study Start Date : February 6, 2019
Actual Primary Completion Date : October 22, 2019
Actual Study Completion Date : October 22, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: IW-6463
IW-6463 tablets administered orally as single ascending doses, multiple ascending daily doses, and single doses with or without food
 Drug: IW-6463
IW-6463 Tablet
Placebo Comparator: Placebo
Matching placebo tablets administered orally
 Drug: Matching Placebo
Matching Placebo Tablet


Outcome Measures
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Primary Outcome Measures :
  1. After single ascending doses, number of subjects with treatment-emergent adverse events (TEAEs) in the IW-6463 dose-level cohorts vs the (pooled) placebo group. [ Time Frame: Up to 9 days ]
  2. After multiple ascending doses, number of subjects with TEAEs in the IW-6463 dose-level cohorts vs the (pooled) placebo group. [ Time Frame: Up to 32 days ]
  3. After a single dose, number of subjects with TEAEs in the fed vs fasted dosing period [ Time Frame: Up to 28 days ]
  4. Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions [ Time Frame: Up to 21 days ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is an ambulatory adult between 18 and 64 years old at the screening visit with the exception of the elderly cohort, who must be 65 years or older at the screening visit.
  • 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
  • Other inclusion criteria per protocol

Exclusion Criteria:

  • Any active or unstable clinically significant medical condition
  • Use of any prescribed or non-prescribed medication
  • Other exclusion criteria per protocol
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856827


Locations
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Netherlands
Centre for Human Drug Research
Leiden, Netherlands, 2333 CL
Sponsors and Collaborators
Cyclerion Therapeutics
Investigators
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Study Director: Chad Glasser, PharmD Cyclerion Therapeutics, Inc
Principal Investigator: Geert J Groeneveld, MSc Centre for Human Drug Research
More Information
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Responsible Party: Cyclerion Therapeutics
ClinicalTrials.gov Identifier: NCT03856827    
Other Study ID Numbers: C6463-101
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes