Alzheimer DiseasePhase 1NCT04585347
Single Dose Study of ALZ-801 Prototype Tablets
A Phase 1 study testing ALZ-801 170 mg Fasting, ALZ-801 205 mg Fasting and ALZ-801 205 mg After Food in people with Alzheimer Disease, run by Alzheon Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- ALZ-801 170 mg Fasting, ALZ-801 205 mg Fasting and ALZ-801 205 mg After Food
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2015to 13 Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females
- Females must be of non-childbearing potential
- Body mass index (BMI) of 18.0 to 35.0 kg/m2
Who cannot join
- 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
About this study
Official 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
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.
Read the detailed description
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).
- Conditions
- Alzheimer Disease
- Being tested
- ALZ-801 170 mg Fasting, ALZ-801 205 mg Fasting, ALZ-801 205 mg After Food, ALZ-801 342 mg Fasting
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALZ-801 170 mg FastingDrug
ALZ-801 205 mg FastingDrug
ALZ-801 205 mg After FoodDrug
ALZ-801 342 mg FastingDrug
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | ALZ-801 171 mg tablet, fasting, once Receives: Drug: ALZ-801 170 mg Fasting |
| Regimen B | Experimental | ALZ-801 205 mg tablet, fasting, once Receives: Drug: ALZ-801 205 mg Fasting |
| Regimen C | Experimental | ALZ-801 205 mg tablet, after food once Receives: 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 Receives: Drug: ALZ-801 342 mg Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax for ALZ-801, tramiprosate, and NRM5074
Maximum observed concentration
Measured: 72 hours after dosing
Tmax for ALZ-801, tramiprosate, and NRM5074
Time from dosing at which Cmax was apparent
Measured: 72 hours after dosing
AUC for ALZ-801, tramiprosate, and NRM5074
Area under the curve from time zero to the last measurable concentration
Measured: 72 hours after dosing
T1/2 for ALZ-801, tramiprosate, and NRM5074
The apparent elimination half-lifee
Measured: 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
Measured: 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
Measured: 72 hours after dosing
Secondary outcomes (1)
Number of participants with adverse events
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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start16 Sep 2015
- Primary completion13 Nov 2015
- Study completion13 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alzheon Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Responsible party
- Sponsor
- Investigators
- Ann Church, PhD, Study director, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585347
- Sponsor's protocol ID
- ALZ-801-104
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29063518
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04585347
- Acronym / sponsor ID
- ALZ-801-104
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Alzheon Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- 13 Nov 2015 (actual)
- Study completion
- 13 Nov 2015 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: ALZ-801 170 mg FastingALZ-801 171 mg tablet, fasting, once |
| Regimen B | Experimental | Drug: ALZ-801 205 mg FastingALZ-801 205 mg tablet, fasting, once |
| Regimen C | Experimental | Drug: ALZ-801 205 mg After FoodALZ-801 205 mg tablet, after food once |
| Regimen D | Experimental | Drug: ALZ-801 342 mg FastingALZ-801 342 mg (administered as 2 x 171 mg tablets of ALZ-801), after food, once |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males and females
- Females must be of non-childbearing potential
- Body mass index (BMI) of 18.0 to 35.0 kg/m2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Cmax for ALZ-801, tramiprosate, and NRM5074
Time frame: 72 hours after dosing
Maximum observed concentration
Tmax for ALZ-801, tramiprosate, and NRM5074
Time frame: 72 hours after dosing
Time from dosing at which Cmax was apparent
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
T1/2 for ALZ-801, tramiprosate, and NRM5074
Time frame: 72 hours after dosing
The apparent elimination half-lifee
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
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
1 secondary outcome
Number of participants with adverse events
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Results publication: PubMed 29063518Hey 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.
- Clinical Pharmacokinetics and Safety of ALZ-801Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Church, PhD study director
Quotient Clinical
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALZ-801 170 mg Fasting, ALZ-801 205 mg Fasting and ALZ-801 205 mg After Food in people with Alzheimer Disease, run by Alzheon Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax for ALZ-801, tramiprosate, and NRM5074 (time frame: 72 hours after dosing). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.