None listed
Conditions
Brief summary
To assess how long modified release prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI). To evaluate the safety of several modified release capsule formulations and a placebo capsule.
Interventions
The intervention is LYN-PLT, a modified release (MR) prototype capsule containing inactive ingredients. The rationale for development of this MR formulation is to reduce the frequency of dosing of orally-administered medications to once weekly or less and thereby improving the management of acute and chronic diseases.
The dose of LYN-PLT to be given is a single Size 00EL capsule containing less than 300 mg sucrose within the formulation's MR formulation (stellate). The capsule will be adminis
The intervention is LYN-PLT, a modified release (MR) prototype capsule containing inactive ingredients. The rationale for development of this MR formulation is to reduce the frequency of dosing of orally-administered medications to once weekly or less and thereby improving the management of acute and chronic diseases. The dose of LYN-PLT to be given is a single Size 00EL capsule containing less than 300 mg sucrose within the formulation's MR formulation (stellate). The capsule will be administered once by a trained nurse (at a minimum) in a hospital (Group 1 and Group 2) or clinic (Group 3, Group 4, and Group 5). There are four arms: Formulation A, Formulation B, Formulation C, and Formulation D with each arm/capsule containing a different type of proprietary stellate. Participants will be randomised to receive only one of the five study formulations (A-E).
Sponsors
Lyndra Australia Pty Ltd.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
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 of capsules, 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 diarrheoa, as evaluated by standardized questionnaire 10) Individuals with contraindications to elective X-ray based on known or expected radiation exposure
Outcome results
None listed