Skip to main content
OpenTrials
Completed

NCT Number: NCT04585347

Single Dose Study of ALZ-801 Prototype Tablets

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

This is a single-center, open-label, non-randomized, sequential, single-dose, 4-period study in 12 healthy adult subjects. Subjects are to receive a single oral dose of ALZ-801 in each of the 4 study periods (Regimens A, B, C and D) in a non-randomized, sequential manner, separated by a minimum washout period of 7 days. The washout period is expected to last approximately 14 days to permit interim decisions to take place and to allow for the selection of the formulation of the subsequent regimen. Periods of interim analysis will take place following dosing with prototype formulations Regimens A, B, and C, during which the PK and safety data are reviewed to determine the dose to be administered in the subsequent treatment period. Interim decisions aim to identify a prototype ALZ-801 immediate release tablet formulation that provides a similar tramiprosate AUC and Cmax to that of historical values after administration of a 100 mg loose-filled tramiprosate capsule in the fasted state.

Optimization of the required tramiprosate exposure will be made by adjusting the dose of ALZ-801 in the prototype tablets using a formulation design space with a target dose range, per tablet, of 171 to 514 mg ALZ-801 (equivalent to 100 mg to 300 mg tramiprosate). Dose selection will be made after a complete review of all data collected from the previous dose group. For dose selection to occur, data is required to be available from a minimum of 8 evaluable subjects with complete safety assessments up to 24 h post-dose, and required safety and PK data (AEs, plasma concentrations of ALZ-801, tramiprosate and NRM5074, and Tmax, Cmax and AUC estimates for ALZ-801 and tramiprosate).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALZ-801 170 mg Fasting

Drug

ALZ-801 205 mg Fasting

Drug

ALZ-801 205 mg After Food

Drug

ALZ-801 342 mg Fasting

Drug

Primary outcomes

  1. Cmax for ALZ-801, tramiprosate, and NRM5074

    Time frame: 72 hours after dosing

    Maximum observed concentration

  2. Tmax for ALZ-801, tramiprosate, and NRM5074

    Time frame: 72 hours after dosing

    Time from dosing at which Cmax was apparent

  3. AUC for ALZ-801, tramiprosate, and NRM5074

    Time frame: 72 hours after dosing

    Area under the curve from time zero to the last measurable concentration

  4. T1/2 for ALZ-801, tramiprosate, and NRM5074

    Time frame: 72 hours after dosing

    The apparent elimination half-lifee

  5. Frel for ALZ-801 and tramiprosate

    Time frame: 72 hours after dosing

    Relative bioavailability of mean PK parameters (AUC[0-inf] and Cmax) for fasted compared to fed state for ALZ-801 and tramiprosate

  6. Frel (test to literature reference)

    Time frame: 72 hours after dosing

    Relative bioavailability of mean PK parameters (AUC[0-inf] and Cmax) for tramiprosate from ALZ-801 prototype tablet formulation compared to previous tramiprosate Phase 3 data

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: 72 hours

    Incidence and nature of adverse events (AEs) and serious adverse events (SAEs). Assessments reported as AEs or SAEs include physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) findings

Sponsors and collaborators

Lead sponsor

Alzheon Inc.

Industry

Collaborators

  • Quotient Clinical

Registry information

Official study title

Four-Period, Single-Dose, Sequential Study in Healthy Adults, to Assess Pharmacokinetics of ALZ-801 and Tramiprosate From ALZ-801 Prototype Tablets and Effect of Food on Bioavailability of ALZ-801 and Tramiprosate for Selected Prototype Tablet

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 14, 2020
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.