A Study of IW-6463 in Healthy Volunteers

August 13, 2024 updated by: Tisento Therapeutics

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands, 2333 CL
        • Centre For Human Drug Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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
Other Names:
  • CY6463
  • zagociguat
Placebo Comparator: Placebo
Matching placebo tablets administered orally
Drug: Matching Placebo
Matching Placebo Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 9 days
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
Up to 32 days
After a single dose, number of subjects with TEAEs in the fed vs fasted dosing period
Time Frame: Up to 28 days
Up to 28 days
Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions
Time Frame: Up to 21 days
Up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tisento Therapeutics

Investigators

  • Study Director: Chad Glasser, PharmD, Cyclerion Therapeutics, Inc
  • Principal Investigator: Geert J Groeneveld, MSc, Centre For Human Drug Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2019

Primary Completion (Actual)

October 22, 2019

Study Completion (Actual)

October 22, 2019

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

February 26, 2019

First Posted (Actual)

February 27, 2019

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • C6463-101
  • CY6463 (Other Identifier: Cyclerion Therapeutics)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Other

Clinical Trials on IW-6463

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe