A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis

• Status: Completed
• Trial end date: 2020-12-17
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled Phase 2A study to evaluate safety, efficacy, PK, and dose response of oral CIN-102 in adults with idiopathic and diabetic gastroparesis. The study will assess three oral doses of CIN-102 versus placebo in three separate cohorts.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CinDome Pharma, Inc.; CinDome Pharma, LLC

Criteria

Inclusion Criteria:

• Male and female patients 18 to 70 years old.

• Current diagnosis of idiopathic or diabetic gastroparesis OR documented delayed gastric emptying.

• Presence of moderate to severe nausea.

• Body mass index (BMI) between 18 and 40 kg/m2, inclusive.

• Glycosylated hemoglobin level <11% at Screening.

• Willing to washout from ongoing treatment for gastroparesis.

• Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.

Exclusion Criteria:

• Other known disorder or treatment which could explain or contribute to symptoms of gastroparesis.

• Positive test for drugs of abuse at the screening or evaluation visits.

• Personal or family history of prolonged heart rate-corrected QT.

• History or evidence of clinically significant arrhythmia.

• History of gastrectomy, fundoplication, vagotomy, pyloroplasty, or bariatric surgery.

• Females who are pregnant, nursing, or planning on becoming pregnant during the study.