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

• Status: Terminated
• Trial end date: 2017-09-18
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Lyndra Inc.
• Treatments: Memantine

Criteria

Inclusion Criteria:

1. Healthy male and female subjects.

2. Body mass index of 18.0 to 32.0 kg/m2.

3. Subjects must demonstrate their ability to swallow a test capsule at screening.

4. Must provide written informed consent.

Exclusion Criteria:

1. Subjects who have received any investigational medicinal product in a clinical research study within the previous 3 months.

2. Subjects who have previously been enrolled in this study.

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

4. Current smokers and those who have smoked within the last 12 months.

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

6. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.

7. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.

8. Individuals with contraindication to MRI imaging.

Other protocol defined criteria may apply.