CompletedEarly Phase 1

Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules in Healthy Adults

Australia40 participantsStarted 2018-06-25

Plain-language summary

To assess how long extended release prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI). To evaluate the safety of several extended release capsule formulations (LYN-PLT) and a placebo capsule.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy male and female subjects
. Body mass index of 18.0 to 30.0 kg/meters-squared
. Suitable scores for two swallowing questionnaires
. Demonstrate normal swallowing and gastrointestinal passage for capsule, as assessed while undergoing imaging studies
. Must provide written informed consent

Exclusion criteria

. Participants who have previously been enrolled in this study
. History of any drug or alcohol abuse in the past 2 years
. Current smokers and those who have smoked within the past 12 months
. Individuals with clinically significant medical history relating to the gastrointestinal tract and potential complications, thereof
. Individuals with a positive test for HIV, hepatitis B or hepatitis C
. Serious adverse reaction or serious hypersensitivity to components of the study formulations or patency capsule

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gastric retention assessed by Magnetic Resonance Imaging (MRI)

Timeframe: Up to 9 Days post-dosing

Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting based on spontaneous reports

Timeframe: Through study completion, up to 6 months

Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting based on changes in examinations pre (Day 1) and post dosing (Days 4 and 7)

Timeframe: Through study completion, up to 6 months

Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting based on post dosing evaluation of bowel movements for blood

Timeframe: Through study completion, up to 6 months

Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting

Timeframe: Through study completion, up to 6 months

Trial details

NCT IDNCT03718390

SponsorLyndra Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-15

View on ClinicalTrials.gov More Gastric Retention trials

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy male and female subjects
. Body mass index of 18.0 to 30.0 kg/meters-squared
. Suitable scores for two swallowing questionnaires
. Demonstrate normal swallowing and gastrointestinal passage for capsule, as assessed while undergoing imaging studies
. Must provide written informed consent

Exclusion criteria

. Participants who have previously been enrolled in this study
. History of any drug or alcohol abuse in the past 2 years
. Current smokers and those who have smoked within the past 12 months
. Individuals with clinically significant medical history relating to the gastrointestinal tract and potential complications, thereof
. Individuals with a positive test for HIV, hepatitis B or hepatitis C
. Serious adverse reaction or serious hypersensitivity to components of the study formulations or patency capsule

What they're measuring

Gastric retention assessed by Magnetic Resonance Imaging (MRI)

Timeframe: Up to 9 Days post-dosing

Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting based on spontaneous reports

Timeframe: Through study completion, up to 6 months

Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting based on post dosing evaluation of bowel movements for blood

Timeframe: Through study completion, up to 6 months

Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting

Timeframe: Through study completion, up to 6 months