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 range18 Years – 40 Years

SexALL

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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
✕. Individuals who have received any experimental agent within 30 days (or 5 half-lives), whichever is longer, prior to the date of dosing
✕. Individuals with contraindication to MRI imaging

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 range18 Years – 40 Years

SexALL

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
✕. Individuals who have received any experimental agent within 30 days (or 5 half-lives), whichever is longer, prior to the date of dosing
✕. Individuals with contraindication to MRI imaging

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