A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Administered Orally as Single Doses to Healthy Subjects

Cyclerion Therapeutics1 site in 1 country24 target enrollmentOctober 2015

ConditionsHealthy

InterventionsIW-1701 Matching Placebo

DrugsIW-1701 Matching Placebo

Overview

Phase: Phase 1
Intervention: IW-1701
Conditions: Healthy
Sponsor: Cyclerion Therapeutics
Enrollment: 24
Locations: 1
Primary Endpoint: Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objectives of the study are to assess the safety and tolerability of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects, to determine the pharmacokinetic profile and pharmacodynamics effects of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

December 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cyclerion Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

IW-1701

Single Dose

Intervention: IW-1701

Matching Placebo for IW-1701

Single Dose

Intervention: Matching Placebo

Outcomes

Primary Outcomes

Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events

Time Frame: From baseline up to 8 days

The primary objectives of this study are to assess the safety and tolerability of single ascending dosage levels of IW-1701 versus placebo in healthy subjects.