Status:
TERMINATED
Study Determining Gastric-Retentive and Modified Release Properties of Prototype Capsules in Healthy Subjects
Lead Sponsor:
Lyndra Inc.
Conditions:
Gastric Retention
Healthy
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief Summary
To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).
Detailed Description
This is a single center, open-label, single dose, 5-period study in 24 healthy male and female subjects, with an optional Period 6, if required. It is expected the study will be executed in 3 cohorts ...
Eligibility Criteria
Inclusion
- Healthy male and female subjects.
- Body mass index of 18.0 to 32.0 kg/m2.
- Subjects must demonstrate their ability to swallow a test capsule at screening.
- Must provide written informed consent.
Exclusion
- Subjects who have received any investigational medicinal product in a clinical research study within the previous 3 months.
- Subjects 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 last 12 months.
- Individuals with clinically significant medical history relating to the gastrointestinal tract and potential for complications, thereof
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
- Individuals with contraindication to MRI imaging.
- Other protocol defined criteria may apply.
Key Trial Info
Start Date :
July 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2017
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03468543
Start Date
July 26 2017
End Date
September 18 2017
Last Update
June 5 2019
Active Locations (1)
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1
Quotient Sciences (formerly Quotient Clinical)
Ruddington, Nottingham, United Kingdom, NG11 6JS