Single Dose Study of ALZ-801 Prototype Tablets

NCT04585347 | Completed Phase 1 FDA Drug

• 1 other identifier: ALZ-801-104
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (6)

• Cmax for ALZ-801, tramiprosate, and NRM5074

  Maximum observed concentration

  72 hours after dosing

• Tmax for ALZ-801, tramiprosate, and NRM5074

  Time from dosing at which Cmax was apparent

  72 hours after dosing

• AUC for ALZ-801, tramiprosate, and NRM5074

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

  72 hours after dosing

• T1/2 for ALZ-801, tramiprosate, and NRM5074

  The apparent elimination half-lifee

  72 hours after dosing

• Frel for ALZ-801 and tramiprosate

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

  72 hours after dosing

• Frel (test to literature reference)

  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

  72 hours after dosing

Secondary Outcomes (1)

• Number of participants with adverse events

  72 hours

Study Arms (4)

Regimen A

EXPERIMENTAL

ALZ-801 171 mg tablet, fasting, once

Drug: ALZ-801 170 mg Fasting

Regimen B

EXPERIMENTAL

ALZ-801 205 mg tablet, fasting, once

Drug: ALZ-801 205 mg Fasting

Regimen C

EXPERIMENTAL

ALZ-801 205 mg tablet, after food once

Drug: ALZ-801 205 mg After Food

Regimen D

EXPERIMENTAL

ALZ-801 342 mg (administered as 2 x 171 mg tablets of ALZ-801), after food, once

Drug: ALZ-801 342 mg Fasting

Interventions

ALZ-801 170 mg Fasting DRUG

Regimen A

ALZ-801 205 mg Fasting DRUG

Regimen B

ALZ-801 205 mg After Food DRUG

Regimen C

ALZ-801 342 mg Fasting DRUG

Regimen D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and females
• Females must be of non-childbearing potential
• Body mass index (BMI) of 18.0 to 35.0 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Alzheon Inc.: lead
• Quotient Clinical: collaborator

Related Publications (1)

• Hey JA, Yu JY, Versavel M, Abushakra S, Kocis P, Power A, Kaplan PL, Amedio J, Tolar M. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer's Disease. Clin Pharmacokinet. 2018 Mar;57(3):315-333. doi: 10.1007/s40262-017-0608-3.

  PMID: 29063518 RESULT

Related Links

• Clinical Pharmacokinetics and Safety of ALZ-801

MeSH Terms

Conditions

Alzheimer Disease

Interventions

ALZ-801; Postprandial Period

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Ann Church, PhD

  Quotient Clinical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects were 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.

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 14, 2020
• Study Start: September 16, 2015
• Primary Completion: November 13, 2015
• Study Completion: November 13, 2015
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share