A Randomized, Open-label, Crossover Study Assessing the Effects of Gelesis200 on Glucose and Insulin Following a Single Administration of Gelesis200 in Healthy Subjects

Gelesis, Inc.1 site in 1 country20 target enrollmentApril 18, 2017

ConditionsObesity Diabetes PreDiabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Gelesis, Inc.
Enrollment: 20
Locations: 1
Primary Endpoint: Safety and Tolerability
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A study to determine glucose and insulin responses to 50g and 100 g of carbohydrate with and without Gelesis200.

Detailed Description

This will be a single centre, open-label, randomized, single-administration, 4-period, 4-way, crossover, pilot study with glycemic and insulin assessments. There is also an option for 2 additional single-administration periods based on the results of an interim analysis. The study includes 2 treatments arms with Gelesis200 (4.20 g 10 minutes before a 50 g carbohydrate breakfast and 4.20 g 10 minutes before a 100 g carbohydrate breakfast) plus 2 control arms consisting of consumption of the breakfasts with water only. The optional periods consist of 1 treatment arm with Gelesis200 and 1 control arm with breakfast and water only. Either only one or both the optional periods may be conducted. The number of additional period(s) to conduct, the amount of Gelesis200 in the treatment arm, as well as the meal composition will be based on interim analysis results.

Registry

clinicaltrials.gov

Start Date

April 18, 2017

End Date

May 18, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Gelesis, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Non-smoker (no use of tobacco products within 6 months prior to screening), ≥ 22 and ≤ 65 years of age, with body mass index (BMI) ≥ 18.5 and \< 30.0 kg/m
•Healthy as defined by:
•the absence of clinically significant illness and surgery within 12 weeks prior to administration. Subjects vomiting within 24 hours pre-administration will be carefully evaluated for upcoming illness/disease. Inclusion pre-administration is at the discretion of the Qualified Investigator.
•the absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease, including, but not limited to pancreatitis, hepatitis B or C, HIV, swallowing disorders, and gastroesophageal reflux disease (at least 1 episode per week).
•the absence of clinically significant history of gastric or peptic ulcer, small bowel resection (except if related to appendectomy), intestinal stricture (e.g., Crohn's disease), intestinal obstruction or high risk of intestinal obstruction including suspected small bowel adhesions.
•the absence of clinically significant history or known presence of esophageal anatomic abnormalities (e.g., webs, diverticuli, rings), gastroparesis, and malabsorption.
•the absence of history of gastric bypass, any other gastric surgery and intragastric balloon.
•the absence of history of angina, coronary bypass, and myocardial infarction within 6 months prior to administration.
•the absence of history of abdominal radiation treatment.
•the absence of history of cancer within the past 5 years, except adequately-treated localized basal cell skin cancer.

Exclusion Criteria

•Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
•Positive urine drug screen at screening.
•History of allergic reactions to carboxymethylcellulose, citric acid, gelatin, titanium dioxide, or other related substances.
•Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
•Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
•History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \[1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]).
•History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
•Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first IP administration, administration of a biological product in the context of a clinical research study within 90 days prior to the first IP administration, or concomitant participation in an investigational study involving no drug or device administration.
•Use of medication other than topical products without significant systemic absorption:
•prescription medication within 30 days prior to the first administration;

Outcomes

Primary Outcomes

Safety and Tolerability

Time Frame: single administration on each of up to 6 days over 6 weeks

AEs, lab abnormalities

Secondary Outcomes

Post prandial glucose(single administration on each of up to 6 days over 6 weeks)
Post prandial insulin(single administration on each of up to 6 days over 6 weeks)