Single Dose Study of ALZ-801 Prototype Tablets

• Status: Completed
• Trial end date: 2015-11-13
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1, single-center, open-label, non-randomized, sequential single dose 4-period study in 12 healthy subjects to assess the pharmacokinetics of ALZ-801, tramiprosate and the primary metabolite of tramiprosate, NRM5074, from prototype drug product formulations of ALZ-801, and to assess effect of food on the bioavailability of ALZ-801 and tramiprosate of the prototype tablet formulation.

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

Details

• Lead Sponsor: Alzheon Inc.
• Collaborator: Quotient Clinical

Criteria

Inclusion Criteria:

• Healthy males and females

• Females must be of non-childbearing potential

• Body mass index (BMI) of 18.0 to 35.0 kg/m2

Exclusion Criteria:

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

• Subjects known to have a creatinine clearance of <60 mL/min

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

• History of cardiovascular, renal, hepatic, neurological, psychiatric, chronic respiratory or gastrointestinal disease as judged by the investigator