Healthy Overweight ObeseNCT02524821
The Effect of Gelesis100 on the Pharmacokinetics of Metformin
A study testing Gelesis100 and Metformin in people with Healthy Overweight Obese, run by Gelesis, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effect of Gelesis100 on the absorption of metformin both with and without a meal. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Overweight Obese
- What is being tested?
- Gelesis100 and Metformin
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, non-smoker (no use of tobacco products within 3 months prior to screening), ≥ 22 and ≤ 65 years of age, with BMI ≥ 25.0 and ≤ 40.0 kg/m2.
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to the first dosing (dosing refers to the administration of Gelesis100 or the substrate drugs, whichever comes first). Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing 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.
- the absence of history of lactic or metabolic acidosis.
- the absence of clinically significant history of gastric or peptic ulcer.
Show all 12Show fewer
- the absence of clinically significant history or known presence of esophageal anatomic abnormalities (e.g., webs, diverticuli, rings), malabsorption, and gastroparesis.
- the absence of history of gastric bypass, any other gastric surgery and intragastric balloon.
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 30 days after the last medical device/substrate drug administration:
- intra-uterine contraceptive device without hormone release system placed at least 4 weeks prior to medical device/substrate drug administration;
- condom with intravaginally applied spermicide starting at least 14 days prior to medical device/substrate drug administration.
- Capable of consent.
Who cannot join
- 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 or urine cotinine test at screening.
- History of allergic reactions to metformin, carboxymethylcellulose, citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, titanium dioxide, or other related drugs or substances.
- Positive pregnancy test at screening.
- Breast-feeding.
- Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
Show all 17Show fewer
- 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 within 30 days (90 days for biologics) prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
- Use of medication other than topical products without significant systemic absorption:
- prescription medication within 14 days prior to the first dosing;
- over-the-counter products including natural health products (e.g., food supplements and herbal supplements) within 7 days prior to the first dosing, 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 dosing.
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL within 30 days, or more than 499 mL within 56 days prior to the first dosing.
- Hemoglobin <128 g/L (males) and <115 g/L (females) and hematocrit <0.37 L/L (males) and <0.32 L/L (females) at screening.
- Subject with a small appetite or who would have difficulty to complete a high-fat, high-caloric meal, or to drink a large amount of liquid.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-label, 4-Way Crossover Study Assessing the Effect of Gelesis100 on the Pharmacokinetics of Metformin, Administered Under Fasting and Fed Conditions
The purpose of this study is to determine the effect of Gelesis100 on the absorption of metformin both with and without a meal.
- Conditions
- Healthy Overweight Obese
- Being tested
- Gelesis100, Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelesis100Device
3 capsules each containing 0.75 mg
MetforminDrug
Also called Glucophage
1 tablet of 850 mg
| Study group | Role | What they receive |
|---|---|---|
| drugs only, fasted | Active comparator | 1 x 850 mg metformin tablet, under fasting conditions. Receives: Drug: Metformin |
| Gelesis100 plus drugs, fasted | Experimental | 3 x 0.75 g Gelesis100 capsules, followed 30 minutes later by the administration of 1 x 850 mg metformin tablet, under fasting conditions. Receives: Device: Gelesis100; Drug: Metformin |
| drugs only, fed | Active comparator | 1 x 850 mg metformin tablet, followed by the ingestion of a high-fat, high-caloric meal. Receives: Drug: Metformin |
| Gelesis100 plus drugs, fed | Active comparator | 3 x 0.75 g Gelesis100 capsules, followed by the ingestion of a high-fat, high-caloric meal, followed by the administration of 1 x 850 mg metformin tablet (fed conditions). Receives: Device: Gelesis100; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Gelesis100 on area under the curve (AUC) for plasma concentration of metformin under fed and fasted conditions
Measured: 0.5 to 24 hours post single dose (19 blood samples)
Effect of Gelesis100 on maximum plasma concentration (Cmax) of metformin under fed and fasted conditions
Measured: 0.5 to 24 hours post single dose (19 blood samples)
Effect of Gelesis100 on time to maximum plasma concentration (Tmax) of metformin under fed and fasted conditions
Measured: 0.5 to 24 hours post single dose (19 blood samples)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Overweight ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gelesis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Audet, Principal investigator, Quebec City, Quebec Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524821
- Sponsor's protocol ID
- GS-100-005
- Status last verified
- Jun 2018
- First submitted
- 13 Aug 2015
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, 4-Way Crossover Study Assessing the Effect of Gelesis100 on the Pharmacokinetics of Metformin, Administered Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT02524821
- Acronym / sponsor ID
- GS-100-005
- Conditions
- Healthy Overweight Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gelesis, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of Gelesis100 on the absorption of metformin both with and without a meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| drugs only, fasted | Active comparator | Drug: Metformin1 x 850 mg metformin tablet, under fasting conditions. |
| Gelesis100 plus drugs, fasted | Experimental | Device: Gelesis100, Drug: Metformin3 x 0.75 g Gelesis100 capsules, followed 30 minutes later by the administration of 1 x 850 mg metformin tablet, under fasting conditions. |
| drugs only, fed | Active comparator | Drug: Metformin1 x 850 mg metformin tablet, followed by the ingestion of a high-fat, high-caloric meal. |
| Gelesis100 plus drugs, fed | Active comparator | Device: Gelesis100, Drug: Metformin3 x 0.75 g Gelesis100 capsules, followed by the ingestion of a high-fat, high-caloric meal, followed by the administration of 1 x 850 mg metformin tablet (fed conditions). |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female, non-smoker (no use of tobacco products within 3 months prior to screening), ≥ 22 and ≤ 65 years of age, with BMI ≥ 25.0 and ≤ 40.0 kg/m2.
- Healthy as defined by:
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 30 days after the last medical device/substrate drug administration:
- Capable of consent.
Key exclusion criteria (17 listed)
- 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 or urine cotinine test at screening.
- History of allergic reactions to metformin, carboxymethylcellulose, citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, titanium dioxide, or other related drugs or substances.
- Positive pregnancy test at screening.
- Breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gelesis1003 capsules each containing 0.75 mg | Device | Gelesis100 plus drugs, fasted, Gelesis100 plus drugs, fed |
| MetforminAlso: Glucophage1 tablet of 850 mg | Drug | Gelesis100 plus drugs, fasted, Gelesis100 plus drugs, fed, drugs only, fasted, drugs only, fed |
Primary outcome
Effect of Gelesis100 on area under the curve (AUC) for plasma concentration of metformin under fed and fasted conditions
Time frame: 0.5 to 24 hours post single dose (19 blood samples)
Effect of Gelesis100 on maximum plasma concentration (Cmax) of metformin under fed and fasted conditions
Time frame: 0.5 to 24 hours post single dose (19 blood samples)
Effect of Gelesis100 on time to maximum plasma concentration (Tmax) of metformin under fed and fasted conditions
Time frame: 0.5 to 24 hours post single dose (19 blood samples)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Healthy Overweight Obese
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Not yet recruitingPhase 1
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Overweight , Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity
Overweight, Obesity
Active, not recruitingPhase 1
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
Healthy Volunteers, Overweight or Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audet principal investigator
Quebec City, Quebec Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelesis100 and Metformin in people with Healthy Overweight Obese, run by Gelesis, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Gelesis100 on area under the curve (AUC) for plasma concentration of metformin under fed and fasted conditions (time frame: 0.5 to 24 hours post single dose (19 blood samples)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.