Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules in Healthy Adults
NCT ID: NCT03718390
Last Updated: 2019-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
40 participants
INTERVENTIONAL
2018-06-25
2018-11-02
Brief Summary
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To evaluate the safety of several extended release capsule formulations (LYN-PLT) and a placebo capsule.
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Detailed Description
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The first 5 subjects enrolled into the study will be regarded as Dosing Group 1 (sentinel group) and assigned to each of the five available study formulations. Dosing of subjects in Dosing Groups 1 and 2 will be performed at the endoscopy centre. Dosing of subjects in Dosing Groups 3 through 5 will be performed at the clinical site.
Subjects remain in the inpatient unit for 7 days after dosing. During this time, subjects undergo intermittent imaging assessments for gastric retention (MRI and abdominal U/S), safety assessments and faecal collections for assessments of retrieved components and bowel movement characteristics.
Subjects return to the clinic on Days 10, 15, 22 and 29 (End of Study visit). Safety assessments will be performed at all visits. MRI, abdominal U/S and outpatient faecal collections may continue based on the clinical findings from subjects dosed with modified release capsule formulations. On Day 29, the subjects will undergo final safety assessments at the clinic and thereafter, will be discharged from the study.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Sentinel Group 1 LYN-PLT
Sentinel dosing in endoscopy center of one of each formulation (A, B, C, D, E) in a 1:1:1:1:1 ratio (centralized randomized, observer blind) and evaluation of gastric retention by MRI
Formulation A
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation B
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation C
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation D
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation E
Placebo Capsule containing microcrystalline cellulose
Endoscopy
Endoscopy at 2 hours post dosing
Magnetic Resonance Imaging
MRI will be performed on specified days according to protocol
Sentinel Group 2 LYN-PLT
Sentinel dosing (second) in endoscopy center of one of each formulation (A, B, C, D, E) in a 1:1:1:1:1 ratio (centralized randomized, observer blind) and evaluation of gastric retention by MRI
Formulation A
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation B
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation C
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation D
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation E
Placebo Capsule containing microcrystalline cellulose
Endoscopy
Endoscopy at 2 hours post dosing
Magnetic Resonance Imaging
MRI will be performed on specified days according to protocol
Group 3 LYN-PLT
Dosing in clinic of two of each formulation (A, B, C, D, E) in a 1:1:1:1:1 ratio (centralized, randomized, observer blind). and evaluation of gastric retention by MRI
Formulation A
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation B
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation C
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation D
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation E
Placebo Capsule containing microcrystalline cellulose
Magnetic Resonance Imaging
MRI will be performed on specified days according to protocol
Group 4 LYN-PLT
Dosing in clinic of two of each formulation (A, B, C, D, E) in a 1:1:1:1:1 ratio (centralized, randomized, observer blind) and evaluation of gastric retention by MRI
Formulation A
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation B
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation C
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation D
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation E
Placebo Capsule containing microcrystalline cellulose
Magnetic Resonance Imaging
MRI will be performed on specified days according to protocol
Group 5 LYN-PLT
Dosing in clinic of two of each formulation (A, B, C, D, E) in a 1:1:1:1:1 ratio (centralized, randomized, observer blind) and evaluation of gastric retention by MRI.
Formulation A
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation B
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation C
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation D
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation E
Placebo Capsule containing microcrystalline cellulose
Magnetic Resonance Imaging
MRI will be performed on specified days according to protocol
Interventions
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Formulation A
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation B
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation C
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation D
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation E
Placebo Capsule containing microcrystalline cellulose
Endoscopy
Endoscopy at 2 hours post dosing
Magnetic Resonance Imaging
MRI will be performed on specified days according to protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
40 Years
ALL
Yes
Sponsors
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Lyndra Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sepehr Shakib, MD
Role: PRINCIPAL_INVESTIGATOR
CMAX
Locations
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CMAX
Adelaide, South Australia, Australia
Countries
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Other Identifiers
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ACTRN12618000991213
Identifier Type: REGISTRY
Identifier Source: secondary_id
CM8818
Identifier Type: OTHER
Identifier Source: secondary_id
LYN-PLT-C-001
Identifier Type: -
Identifier Source: org_study_id
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