A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
- Conditions
- Gastroparesis
- Interventions
- Drug: CIN-102 Dose 1Drug: PlaceboDrug: CIN-102 Dose 2Drug: CIN-102 Dose 3
- Registration Number
- NCT04026997
- Lead Sponsor
- CinDome Pharma, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 CIN-102 Dose 1 CIN-102 tablets by mouth twice daily for 14 days Cohort 1 - Placebo Placebo Placebo tablets by mouth twice daily for 14 days Cohort 2 CIN-102 Dose 2 CIN-102 tablets by mouth twice daily for 14 days Cohort 2- Placebo Placebo Placebo tablets by mouth twice daily for 14 days Cohort 3 CIN-102 Dose 3 CIN-102 tablets by mouth twice daily for 14 days Cohort 3- Placebo Placebo Placebo tablets by mouth twice daily for 14 days
- Primary Outcome Measures
Name Time Method Change from baseline in gastric emptying Baseline (gathered on Days -10 to -3) to Day 14
- Secondary Outcome Measures
Name Time Method The change from baseline in ANMS GCSI-DD subscale scores Day -14 to 14 Change from baseline in gastric emptying terminal phase elimination half life Baseline (gathered on Days -10 to -3) to Day 14 The change from baseline in ANMS GCSI-DD total scores Day -14 to 14
Trial Locations
- Locations (19)
Research Site 109
🇺🇸Great Neck, New York, United States
Research Site 107
🇺🇸Jackson, Tennessee, United States
Research Site 114
🇺🇸Jacksonville, Florida, United States
Research Site 101
🇺🇸Chula Vista, California, United States
Research Site 117
🇺🇸Miami, Florida, United States
Research Site 118
🇺🇸Miami, Florida, United States
Research Site 111
🇺🇸Atlanta, Georgia, United States
Research Site 103
🇺🇸Louisville, Kentucky, United States
Research Site 110
🇺🇸Kansas City, Kansas, United States
Research Site 112
🇺🇸Marrero, Louisiana, United States
Research Site 104
🇺🇸Monroe, Louisiana, United States
Research Site 102
🇺🇸Boston, Massachusetts, United States
Research Site 120
🇺🇸Winston-Salem, North Carolina, United States
Research Site 119
🇺🇸Summerville, South Carolina, United States
Research Site 115
🇺🇸Rapid City, South Dakota, United States
Research Site 105
🇺🇸Tulsa, Oklahoma, United States
Research Site 106
🇺🇸Philadelphia, Pennsylvania, United States
Research Site 113
🇺🇸Las Vegas, Nevada, United States
Research Site 121
🇺🇸Omaha, Nebraska, United States