Stopped: The study was prematurely terminated due to enrollment challenges.
The objectives of this study are as follows: In participants with primary Type I or II achalasia, following a single 5-mg dose of olinciguat (IW-1701), * To assess the safety and tolerability * To determine the effects on measures of esophageal function by high-resolution impedance manometry (HRIM) * To determine the pharmacokinetic (PK) parameters
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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs)
Timeframe: Deaths, SAEs, and AEs: from enrollment through end-of-trial visit Day 21 (±7 days). TEAEs: from first dose of study drug through 72 hours postdose.
Change From Baseline in Supine Bolus Flow Time (BFT)
Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Change From Baseline in Upright BFT
Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Change From Baseline in Supine Integrated Relaxation Pressure (IRP)
Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Change From Baseline in Upright IRP
Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Change From Baseline in 1 Minute Impedance Bolus Height (IBH)
Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Change From Baseline in 2 Minute IBH
Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Change From Baseline in 5 Minute IBH
Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Area Under the Plasma Concentration Time Curve From Time 0 to the Last Observation (AUClast)
Timeframe: Day 1 predose: 0 (≤15 minutes); Day 1 postdose: 0.5 hours (±2 minutes), 1, 2, 3, 4, 5, 6, 8 hours (±5 minutes), 12, 17 hours (±15 minutes). Day 2 postdose 24 hours (±30 minutes). End of Treatment Visit: Day 21 (±7 days).
Maximum Observed Plasma Concentration (Cmax)
Timeframe: Day 1 predose: 0 (≤15 minutes); Day 1 postdose: 0.5 hours (±2 minutes), 1, 2, 3, 4, 5, 6, 8 hours (±5 minutes), 12, 17 hours (±15 minutes). Day 2 postdose 24 hours (±30 minutes). End of Treatment Visit: Day 21 (±7 days).
Time of Maximum Observed Plasma Concentration (Tmax)
Timeframe: Day 1 predose: 0 (≤15 minutes); Day 1 postdose: 0.5 hours (±2 minutes), 1, 2, 3, 4, 5, 6, 8 hours (±5 minutes), 12, 17 hours (±15 minutes). Day 2 postdose 24 hours (±30 minutes). End of Treatment Visit: Day 21 (±7 days).