A 2-Stage Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Tablets in Healthy Subjects in a Double-blind, Placebo-controlled, Multiple-ascending-dose Stage and an Open-label, Single-dose, Crossover Food-effect Stage
Overview
- Phase
- Phase 1
- Intervention
- IW-1701
- Conditions
- Healthy
- Sponsor
- Cyclerion Therapeutics
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Treatment Emergent Adverse Event
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The objectives of this study are:
Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects over 7 days of repeated dosing
Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets administered orally to healthy subjects, in fed and fasted states, in an open-label, single-dose, 2-period, 2-sequence crossover study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is an ambulatory male or female between 18 and 55 years old at the screening visit
- •Subject's body mass index score is \> 18.5 and \< 30.0 kg/m2 at the screening visit
- •Women of childbearing potential must have a negative pregnancy test at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study
- •Subject is in good health and has no clinically significant findings on a physical examination
- •Other inclusion criteria per protocol
Exclusion Criteria
- •History of any clinically significant medical conditions
- •Other exclusion criteria per protocol
Arms & Interventions
IW-1701
IW-1701 tablets administered orally in multiple ascending dose.
Intervention: IW-1701
Placebo
Matching placebo tablets administered orally.
Intervention: Placebo
Outcomes
Primary Outcomes
Treatment Emergent Adverse Event
Time Frame: 47 Days
Maximum observed plasma concentration [Cmax]
Time Frame: 47 Days
Maximum observed Plasma Concentration
Area under the plasma concentration time curve during a dosing interval [AUC]
Time Frame: 47 Days
Area under the plasma concentration time curve during a dosing interval
Time of maximum observed plasma concentration [Tmax]
Time Frame: 47 Days
Time of maximum observed plasma concentration
Blood Pressure
Time Frame: 47 Days