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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02931565
Other study ID # C1701-201
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date April 6, 2017
Est. completion date May 1, 2018

Study information

Verified date April 2021
Source Cyclerion Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date May 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Key Inclusion Criteria: - Patient has a diagnosis of primary Type I or II achalasia. - Patient has no contraindications to the performance of the baseline and postdose HRIM procedures per Investigator discretion. Key Exclusion Criteria: - Patient has had any prior esophageal, periesophageal, or gastric surgery, or treatment with sclerosing agent. - More than 1 pneumatic dilation procedure to a diameter of > 2 cm in their lifetime. - Pneumatic dilation procedure to a diameter of > 2 cm within 1 year prior to randomization. Prior bougie dilation(s) or pneumatic dilation(s) = 2 cm are allowed. - Prior esophageal injection of botulinum toxin (Botox) within 6 months prior to randomization or more than 2 esophageal Botox injection procedures in their lifetime. - Patients with malignant or premalignant esophageal lesions. - Patient has taken any drug that can affect gastrointestinal (GI) motility in the 72 hours before check-in through discharge from the clinic. Other inclusion and exclusion criteria specified in the protocol.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Olinciguat
oral tablet
Matching Placebo
oral tablet

Locations

Country Name City State
United States Connecticut Clinical Research Foundation, Gastroenterology Institute Bristol Connecticut
United States Vanderbilt University Medical Center Nashville Tennessee
United States Mayo Clinic Rochester Minnesota
United States Washington University in St. Louis - School of Medicine Saint Louis Missouri
United States University of Utah School of Medicine, Division of Gastroenterology, Hepatology & Nutrition Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Cyclerion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs) An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with study treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: death; life-threatening: the patient was at immediate risk of death from the reaction as it occurred; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical event. Deaths and SAEs include those that occurred on or after the participant signed the informed consent at the Screening Visit through the End-of-Trial Visit. TEAEs are defined as adverse events that occurred on/after administration of the double-blind study drug and within 72 hours after the double-blind study drug administration. 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.
Primary Change From Baseline in Supine Bolus Flow Time (BFT) Supine BFT defined as the median measurement from the 10 available swallows in supine position as measured by high resolution impedance manometry (HRIM), and determined by the central read (seconds; longer times=more severe achalasia). Change=(postdose supine BFT - predose supine BFT). Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Primary Change From Baseline in Upright BFT Upright BFT defined as the median measurement from the 5 available swallows in the upright position as measured by HRIM, and determined by the central read (seconds; longer times=more severe achalasia). Change = (postdose upright BFT - predose upright BFT). Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Primary Change From Baseline in Supine Integrated Relaxation Pressure (IRP) Supine IRP defined as the median measurement from the 10 available swallows in supine position as determined by the central read (mmHg; higher pressure=more severe achalasia), measured by HRIM. Change = (postdose supine IRP - predose supine IRP). Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Primary Change From Baseline in Upright IRP Upright IRP is defined as the median measurement from the 5 available swallows in the supine position as determined by the central read (mmHg; higher pressure=more severe achalasia), measured by HRIM. Change = (postdose upright IRP - predose upright IRP). Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Primary Change From Baseline in 1 Minute Impedance Bolus Height (IBH) 1 minute IBH defined by the height in esophagus of 200 mL saline bolus 1 minute post-bolus as measured by HRIM and determined by the central read (cm; greater height=more severe achalasia). Change = (postdose height 1 min IBH - predose height 1 min IBH) Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Primary Change From Baseline in 2 Minute IBH 2 minute IBH defined by the height in esophagus of 200 mL saline bolus 2 minutes post-bolus as measured by HRIM and determined by the central read (cm; greater height=more severe achalasia). Change = (postdose height 2 min IBH - predose height 2 min IBH). Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Primary Change From Baseline in 5 Minute IBH 5 minute IBH defined by the height in esophagus of 200 mL saline bolus 5 minutes post-bolus as determined by the central read (cm; greater height=more severe achalasia). Change = (postdose height 5 min IBH - predose height 5 min IBH). Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Primary Area Under the Plasma Concentration Time Curve From Time 0 to the Last Observation (AUClast) 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).
Primary Maximum Observed Plasma Concentration (Cmax) 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).
Primary Time of Maximum Observed Plasma Concentration (Tmax) 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).
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