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Single Dose Study of ALZ-801 Prototype Tablets

NCT04585347 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-10-14

No results posted yet for this study

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

Interventions

DRUG

ALZ-801 170 mg Fasting

DRUG

ALZ-801 205 mg Fasting

DRUG

ALZ-801 205 mg After Food

DRUG

ALZ-801 342 mg Fasting

Sponsors & Collaborators

  • Quotient Clinical

    collaborator OTHER

  • Alzheon Inc.

    lead INDUSTRY

Principal Investigators

  • Ann Church, PhD · Quotient Clinical

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-16
Primary Completion
2015-11-13
Completion
2015-11-13
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04585347 on ClinicalTrials.gov