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Trial record 2 of 3 for:    IW-6463
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IW-6463 Safety Study in Healthy Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240158
Recruitment Status : Terminated (Some subjects could not complete the second crossover period due to COVID-19-related site closure. The study was closed to allow analysis of all collected data.)
First Posted : January 27, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Cyclerion Therapeutics

Study Description
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Brief Summary:
This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants.

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

Detailed Description:
Participants will receive up to a total of 30 daily doses of study drug (15 days of daily IW-6463, only; 15 days of daily placebo, only) administered across two 15-day dosing periods (Period 1 and Period 2). The dosing periods will be separated by a 27-day washout. Participants will be randomized to a sequence of receiving IW-6463 for Period 1 and then placebo for Period 2, or vice versa.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Safety, Tolerability, and Pharmacodynamic Properties of IW-6463 in Healthy Elderly Subjects
Actual Study Start Date : January 6, 2020
Actual Primary Completion Date : May 22, 2020
Actual Study Completion Date : May 22, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: IW-6463
IW-6463 tablets administered orally
 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. Change From Baseline in Cerebral Blood Flow (CBF) at Day 15 [ Time Frame: Baseline, 15 days ]
    Change from baseline in CBF as measured by magnetic resonance imaging (MRI) and arterial spin labeling (ASL) after administration of IW-6463 vs. placebo

  2. Number of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 42 days ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is an ambulatory adult at least 65 years old at the screening visit
  • Subject is in good health and has no clinically significant findings on physical examination
  • Female participants must be postmenopausal. A postmenopausal state is defined as no menses for ≥12 consecutive months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level at screening (>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state.
  • Male participants who have not been surgically sterilized by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) must agree contraceptive use per protocol
  • Men must also agree 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
  • 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): NCT04240158


Locations
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Netherlands
Centre for Human Drug Research (CHDR)
Leiden, Netherlands
Sponsors and Collaborators
Cyclerion Therapeutics
Investigators
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Study Director: Chad Glasser, PharmD Cyclerion Therapeutics, Inc
Principal Investigator: Geert Jan Groeneveld, MSc Centre for Human Drug Research
More Information
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Responsible Party: Cyclerion Therapeutics
ClinicalTrials.gov Identifier: NCT04240158    
Other Study ID Numbers: C6463-102
CY6463 ( Other Identifier: Cyclerion Therapeutics )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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