Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type I or II Achalasia


About this study

The objectives of this study are as follows: In patients with primary Type I or II Achalasia, following a single 5-mg dose of 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, Cmax, Tmax, and AUClast

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

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 GI motility in the 72 hours before Check-in through Discharge from the clinic.
  • Other exclusion criteria specified in the protocol.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

David Katzka, M.D.

Closed for enrollment

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