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

Phase 2TerminatedNCT04026997

CinDome Pharma, Inc.72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gastroparesis

Interventions

CIN-102 Dose 1DRUG

CIN-102 Dose 1

CIN-102 Dose 2DRUG

CIN-102 Dose 2

CIN-102 Dose 3DRUG

CIN-102 Dose 3

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (19)

Research Site 101

Chula Vista, California, United States

Research Site 114

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

The Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)

The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE), after consumption of a standardized 13C-enriched meal. GEBT T1/2 is the time for half of the ingested meal to leave the stomach. It is reported using kPCD, a mathematical expression of a test subject's 13CO2 excretion rate per minute at any measurement time t relative to the dose of 13C contained in the test meal.

Time frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

The Percent Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)

Time frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

Secondary Outcomes

The Change From Baseline in GE as Measured by the GEBT Excretion Rate

The value and change from baseline in GEBT excretion rate (kPCD per minute) were summarized by treatment group. The value and time-matched (to baseline visit) change from baseline of the GEBT results for each post-meal time point were also summarized by treatment group.

Time frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

The Percent Change From Baseline in GE as Measured by the GEBT Excretion Rate

The percent change from baseline in GEBT excretion rate (kPCD per minute) was summarized by treatment group. The percent change from baseline of the GEBT results for each post-meal time point was also summarized by treatment group.

Data from ClinicalTrials.gov

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Research Site 117

Miami, Florida, United States

Research Site 118

Miami, Florida, United States

Research Site 111

Atlanta, Georgia, United States

Research Site 110

Kansas City, Kansas, United States

Research Site 103

Louisville, Kentucky, United States

Research Site 112

Marrero, Louisiana, United States

Research Site 104

Monroe, Louisiana, United States

Research Site 102

Boston, Massachusetts, United States

...and 9 more locations

Time frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

The Change From Baseline in ANMS GCSI-DD Total Scores

American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) total and subscale scores and change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.