Multiple Ascending Dose Study of ALZ-801

NCT04157712 | Completed Phase 1 FDA Drug

• 1 other identifier: ALZ-801-103
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I, single-center, double-blind, randomized, placebo-controlled, parallel-group study of the safety, tolerability, and pharmacokinetics (PK) in plasma and urine, of multiple ascending doses of ALZ-801 (capsule, Part 1; prototype tablet Part 2) and the primary metabolite in healthy male or female subjects.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (6)

• Number of participants with adverse events as a measure of safety and tolerability

  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

  Duration of dosing: 14 days for Part 1; 7 days for Part 2

• Cmax for ALZ-801 and tramiprosate

  Maximum concentration after dosing \[Cmax\] measured as ng/ml

  Days 1, 7 and 14

• Tmax for ALZ-801 and tramiprosate

  Time to reach Cmax \[Tmax\] measured in hours (h) after dosing

  Days 1, 7 and 14

• AUC for ALZ-801 and tramiprosate

  AUC from time zero to time t (AUCt)

  Days 1, 7 and 14

• t1/2 for ALZ-801 and tramiprosate

  Elimination half-life (t1/2) measured in hours after dosing

  Days 1, 7, 14

• Renal clearance of ALZ-801 and tramiprosate

  Clearance (CLr) measured in mL/min

  Days 1, 7 and 14

Study Arms (4)

Cohort A Capsule - Fasted

EXPERIMENTAL

ALZ-801 171 mg or matching placebo once daily Day 1, ALZ-801 171 mg or matching placebo twice daily Days 2-7, ALZ-801 256.5 mg or matching placebo once daily Days 8-14

Drug: ALZ-801 or matching placebo

Cohort B Capsule - Fasted

EXPERIMENTAL

ALZ-801 256.5 mg or matching placebo once daily Day 1, ALZ-801 256.5 or matching placebo mg twice daily Days 2-7, ALZ-801 340 mg or matching placebo once daily Days 8-14

Drug: ALZ-801 or matching placebo

Cohort C Capsule - Fed

EXPERIMENTAL

ALZ-801 256.5 mg or matching placebo once daily Day 1, ALZ-801 256.5 mg or matching placebo twice daily Days 2-7, ALZ-801 340 mg or matching placebo twice daily Days 8-13, ALZ-801 340 mg or matching placebo once daily Day 14

Drug: ALZ-801 or matching placebo

Cohort D Tablet - Fed

EXPERIMENTAL

ALZ-801 265 mg or matching placebo once daily Day 1, ALZ-801 265 mg or matching placebo twice daily Days 2-6, ALZ-801 265 mg or matching placebo once daily Day 7

Drug: ALZ-801 or matching placebo

Interventions

ALZ-801 or matching placebo DRUG

Cohort A Capsule - Fasted; Cohort B Capsule - Fasted; Cohort C Capsule - Fed; Cohort D Tablet - Fed

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males, and females
• Age: 50-75 years, Part 1; 60-75 years Part 2
• Females must be of non-childbearing potential
• Body Mass Index 18-35 kg/m squared;
• Vital signs normal for age: BP 90-160/40-90 mmHg; HR 50 to 90 bpm)
• No clinically significant electrocardiogram readings

You may not qualify if:

• Body weight \< 50 kg
• 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 clinically significant cardiovascular, pulmonary, chronic respiratory, renal, hepatic, GI, immunologic, endocrine, neurologic, psychiatric or thromboembolic disease
• History of metabolic disturbances;

Sponsors & Collaborators

• Alzheon Inc.: lead
• Quotient Clinical: collaborator

Study Sites (1)

Quotient Clinical

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

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

MeSH Terms

Conditions

Alzheimer Disease

Interventions

ALZ-801

Condition Hierarchy (Ancestors)

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

Study Officials

• Pui Leung, MD

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind, placebo controlled, matching placebo
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double blind, placebo controlled, matching placebo

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 8, 2019
• Study Start: September 26, 2015
• Primary Completion: July 4, 2016
• Study Completion: July 4, 2016
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)