NCT04240158

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2020

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

January 21, 2020

Last Update Submit

August 13, 2024

Conditions

Other

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Cerebral Blood Flow (CBF) at Day 15

    Change from baseline in CBF as measured by magnetic resonance imaging (MRI) and arterial spin labeling (ASL) after administration of IW-6463 vs. placebo

    Baseline, 15 days

  • Number of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs)

    Up to 42 days

Study Arms (2)

IW-6463

EXPERIMENTAL

IW-6463 tablets administered orally

Drug: IW-6463

Placebo

PLACEBO COMPARATOR

Matching placebo tablets administered orally

Drug: Matching Placebo

Interventions

IW-6463DRUG

IW-6463 Tablet

Also known as: CY6463, zagociguat
IW-6463
Matching PlaceboDRUG

Matching Placebo Tablet

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any active or unstable clinically significant medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Human Drug Research (CHDR)

Leiden, Netherlands

Location

Study Officials

  • Chad Glasser, PharmD

    Cyclerion Therapeutics, Inc

    STUDY DIRECTOR

  • Geert Jan Groeneveld, MSc

    Centre for Human Drug Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 27, 2020

Study Start

January 6, 2020

Primary Completion

May 22, 2020

Study Completion

May 22, 2020

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)