Trial | NCT04026997  Report issue

Title

A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Dose Response of Oral CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    73
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 Started
Sep 11
2019
Primary Completion
Dec 17
2020
Study Completion
Dec 17
2020
Last Update
Jul 21
2021

Drug CIN-102 Dose 1

CIN-102 Dose 1

Drug CIN-102 Dose 2

CIN-102 Dose 2

Drug CIN-102 Dose 3

CIN-102 Dose 3

Drug Placebo

Placebo

Cohort 1 Experimental

CIN-102 tablets by mouth twice daily for 14 days

Cohort 1 - Placebo Placebo Comparator

Placebo tablets by mouth twice daily for 14 days

Cohort 2 Experimental

CIN-102 tablets by mouth twice daily for 14 days

Cohort 2- Placebo Placebo Comparator

Placebo tablets by mouth twice daily for 14 days

Cohort 3 Experimental

CIN-102 tablets by mouth twice daily for 14 days

Cohort 3- Placebo Active Comparator

Placebo tablets by mouth twice daily for 14 days

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.
No Results Posted