Gelesis200 Safety and Tolerability Study and Effects on Glycemic and Appetite Parameters

NCT02652962 | Completed

• 1 other identifier: GS-200-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and tolerability of Gelesis200.

Conditions

Healthy Overweight Obese

Outcome Measures

Primary Outcomes (4)

• Safety/tolerability of Gelesis200 administered two times per day 10 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination

  Treatment-emergent AEs will be tabulated by treatment and cohort. Changes from baseline values in vital signs and clinical laboratory parameters will be evaluated.

  24 hours post administration

• Safety/tolerability of Gelesis200 administered three times per day 10 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination

  Treatment-emergent AEs will be tabulated by treatment and cohort. Changes from baseline values in vital signs and clinical laboratory parameters will be evaluated.

  24 hours post administration

• Safety/tolerability of Gelesis200 administered two times per day 30 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination

  Treatment-emergent AEs will be tabulated by treatment and cohort. Changes from baseline values in vital signs and clinical laboratory parameters will be evaluated.

  24 hours post administration

• Safety/tolerability of Gelesis200 administered three times per day 30 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination

  Treatment-emergent AEs will be tabulated by treatment and cohort. Changes from baseline values in vital signs and clinical laboratory parameters will be evaluated.

  24 hours post administration

Other Outcomes (9)

• Postprandial plasma glucose: AUC

  -30 to 210 min post meal (two meals)

• Postprandial plasma glucose: Tmax

  -30 to 210 min post meal (two meals)

• Postprandial plasma glucose: Cmax

  -30 to 210 min post meal (two meals)

Study Arms (8)

Gelesis200 x 2, 10 min

EXPERIMENTAL

3 x 0.70g Gelesis200 capsules administered 10 minutes before each of 2 meals (breakfast, lunch).

Device: Gelesis200

Gelesis200 x 2, 30 min

EXPERIMENTAL

3 x 0.70g Gelesis200 capsules administered 30 minutes before each of 2 meals (breakfast, lunch).

Device: Gelesis200

Placebo x 2, 10 min

PLACEBO COMPARATOR

3 x Placebo capsules administered 10 minutes before each of 2 meals (breakfast, lunch).

Other: Placebo

Placebo x 2, 30 min

PLACEBO COMPARATOR

3 x Placebo capsules administered 30 minutes before each of 2 meals (breakfast, lunch).

Other: Placebo

Gelesis200 x 3, 10 min

EXPERIMENTAL

3 x 0.70g Gelesis200 capsules administered 10 minutes before each of 3 meals (breakfast, lunch, dinner).

Device: Gelesis200

Gelesis200 x 3, 30 min

EXPERIMENTAL

3 x 0.70g Gelesis200 capsules administered 30 minutes before each of 2 meals (breakfast, lunch).

Device: Gelesis200

Placebo x 3, 10 min

PLACEBO COMPARATOR

3 x Placebo capsules administered 10 minutes before each of 3 meals (breakfast, lunch, dinner).

Other: Placebo

Placebo x 3, 30 min

PLACEBO COMPARATOR

3 x Placebo capsules administered 30 minutes before each of 3 meals (breakfast, lunch, dinner).

Other: Placebo

Interventions

Gelesis200 DEVICE

3 capsules each containing 0.70 g

Gelesis200 x 2, 10 min; Gelesis200 x 2, 30 min; Gelesis200 x 3, 10 min; Gelesis200 x 3, 30 min

Placebo OTHER

3 capsules each containing 0.57 g of a mixture of microcrystalline cellulose and maltodextrin in a ratio of approximately 50 ± 10%

Also known as: maltodextrin/microcrystalline cellulose

Placebo x 2, 10 min; Placebo x 2, 30 min; Placebo x 3, 10 min; Placebo x 3, 30 min

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, non-smoker (no use of tobacco products within 6 months prior to screening), ≥ 22 and ≤ 65 years of age, with BMI ≥ 27.0 and \< 35.0 kg/m2.
• Healthy as defined by:
• 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.
• Capable of consent.
• Fasting plasma glucose ≥ 90 and \<126 mg/dL (equivalent to ≥ 5.0 and \< 7.0 mmol/L) at screening.
• Notwithstanding the lower limit of 90 mg/dL (equivalent to 5.0 mmol/L), subjects with higher fasting plasma glucose will be prioritized, and efforts will be made to include subjects with fasting plasma glucose ≥ 100 mg/dL (equivalent to ≥ 5.6 mmol/L) in both cohorts.

You may not qualify if:

• 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, modified cellulose, microcrystalline cellulose, maltodextrin, 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 electrocardiogram (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 \[PCP\], and crack) within 1 year prior to screening.
• Participation in a clinical trial involving the administration of an investigational or marketed drug or device within 30 days (90 days for biologics) prior to the first administration or concomitant participation in an investigational study involving no drug or device.
• Use of medication other than topical products without significant systemic absorption:
• prescription medication within 30 days prior to the first administration;
• over-the-counter products including natural health products (e.g., food supplements and herbal supplements) within 7 days prior to the first administration, with the exception of the occasional use of acetaminophen (up to 2 g daily);
• a depot injection or an implant of any drug within 3 months prior to the first administration.
• Donation of plasma within 7 days prior to the first administration. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first administration.
• Hemoglobin \< 140 g/L and hematocrit \< 0.37 L/L at screening.
• Glycosylated hemoglobin (HbA1c ≥ 6.5% which is equivalent to ≥ 48 mmol/mol).

Sponsors & Collaborators

• Gelesis, Inc.: lead

Study Sites (1)

Unknown Facility

Québec, Quebec, Canada

Location

MeSH Terms

Interventions

maltodextrin; microcrystalline cellulose

Study Officials

• Audet

  Quebec City, Quebec Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: January 12, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 9, 2016

Record last verified: 2016-05

Locations

CA (1)