TerminatedEarly Phase 1

Study Determining Gastric-Retentive and Modified Release Properties of Prototype Capsules in Healthy Subjects

Stopped: Per protocol stopping rules

United Kingdom3 participantsStarted 2017-07-26

Plain-language summary

To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Gastric Retention by Magnetic Resonance Imaging (MRI)

Timeframe: 7 Days

Trial details

NCT IDNCT03468543

SponsorLyndra Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09-18

Results submitted2018-03-19

View on ClinicalTrials.gov More Gastric Retention trials