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

• Status: Completed
• Trial end date: 2018-11-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lyndra Inc.

Criteria

Inclusion Criteria:

1. Healthy male and female subjects

2. Body mass index of 18.0 to 30.0 kg/meters-squared

3. Suitable scores for two swallowing questionnaires

4. Demonstrate normal swallowing and gastrointestinal passage for capsule, as assessed while undergoing imaging studies

5. Must provide written informed consent

Exclusion Criteria:

1. Participants who have previously been enrolled in this study

2. History of any drug or alcohol abuse in the past 2 years

3. Current smokers and those who have smoked within the past 12 months

4. Individuals with clinically significant medical history relating to the gastrointestinal tract and potential complications, thereof

5. Individuals with a positive test for HIV, hepatitis B or hepatitis C

6. Serious adverse reaction or serious hypersensitivity to components of the study formulations or patency capsule

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

8. Individuals with contraindication to MRI imaging

9. Individuals with functional constipation, irritable bowel, or functional diarrhea, as evaluated by standardized questionnaire

10. Individuals with contraindications to elective X-ray based on known or expected radiation exposure