A Trial of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Healthy Subjects

Cyclerion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: IW-1701; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02792998

ICP-1701-102

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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67 participants in 2 patient groups, including a placebo group

IW-1701

Experimental group

Description:

IW-1701 tablets administered orally in multiple ascending dose.

Treatment:

Drug: IW-1701

Placebo

Placebo Comparator group

Description:

Matching placebo tablets administered orally.

Treatment:

Drug: Placebo