IW-6463 Safety Study in Healthy Elderly Subjects
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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
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Condition or disease | Intervention/treatment | Phase |
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Other | Drug: IW-6463 Drug: Matching Placebo | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: IW-6463
IW-6463 tablets administered orally
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Drug: IW-6463
IW-6463 Tablet |
Placebo Comparator: Placebo
Matching placebo tablets administered orally
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Drug: Matching Placebo
Matching Placebo Tablet |
- 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
- Number of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 42 days ]

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

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
Netherlands | |
Centre for Human Drug Research (CHDR) | |
Leiden, Netherlands |
Study Director: | Chad Glasser, PharmD | Cyclerion Therapeutics, Inc | |
Principal Investigator: | Geert Jan Groeneveld, MSc | Centre for Human Drug Research |
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 |
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 |