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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240158
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Cyclerion Therapeutics

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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


Contacts
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Contact: Paul Miller +1 857 338 3355 PMiller@Cyclerion.com

Locations
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Netherlands
Centre for Human Drug Research (CHDR) Recruiting
Leiden, Netherlands
Contact: Study Lead    +31 71 5246 400      
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

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Responsible Party: Cyclerion Therapeutics
ClinicalTrials.gov Identifier: NCT04240158    
Other Study ID Numbers: C6463-102
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 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