Healthy VolunteersPhase 1NCT04932655

Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers

A Phase 1 study testing simufilam in people with Healthy Volunteers, run by Cassava Sciences, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will compare the pharmacokinetics of the Phase 3 simufilam 100 mg oral tablet when taken fasted versus following a high-fat or low-fat meal. Additionally, the Phase 3 oral tablet will be compared to the Phase 2 oral tablet for bioequivalence under fasted conditions. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: simufilam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 4 May 2021to 11 May 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female subjects, Ages ≥ 18 and ≤ 45 years
BMI of 18 - 30 Kg/m²
Informed consent form (ICF) signed by the subject
General health status acceptable for participation in the study as determined by medical history, review of current medication, physical examination, and laboratory results
Fluency (oral and written) in English
The patient must agree to comply with the drawing of blood samples for the PK assessments, laboratory assessments and plasma biomarkers
The subject is willing and able to remain at the study site for the duration of the study

Who cannot join

The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
The subject has had a clinically significant illness within 30 days of this study.
The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
Subject is taking prescription CNS medication.
The subject has used alcohol, grapefruit, grapefruit juice, caffeine or xanthinecontaining products 48 h before dosing or intends to use any of these products during the study.
The subject has a history of substance abuse or a current positive ethanol breath test or positive urine drug screen.

Show all 13Show fewer

The subject has a positive serum hepatitis B surface antigen or positive HCV antibody test.
The subject has a positive HIV test.
The subject has a current positive urine cotinine test.
The subject has participated in another drug study in the past 30 days.
The subject has donated or lost a significant volume of blood (>450 mL) within 4 weeks of the study.
The subject is unwilling to reside in the study unit for the duration of the study or to cooperate fully with the investigator or site personnel.
Covid-19 infection within the past 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Worldwide Clinical Trials Phase I Unit
San Antonio, Texas, 78217

Other trials in United States

About this study

Official title: A Four-way Crossover Food Effect and Bioequivalence Pharmacokinetic Study of Simufilam in Healthy Volunteers

Read the detailed description

This is a single-center, randomized, four-treatment, four-sequence crossover study in healthy volunteers to estimate the effect of food on the pharmacokinetics of simufilam following oral 100 mg Phase 3 oral tablets. Additionally, the relative bioavailability of the Phase 3 100 mg tablet will be compared to the earlier Phase 2 100 mg tablet in the fasted state. A total of twenty four (24) healthy volunteers (12 male and 12 female) will be enrolled into this study. Subjects will be randomly assigned to one of four treatment sequences (6 subjects/sequence).

Conditions: Healthy Volunteers
Being tested: simufilam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

simufilamDrug
Also called PTI-125
Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.

Study groups in NCT04932655
Study group	Role	What they receive
Sequence A	Other	This arm received Phase 2 tablet fasted (Period 1), Phase 3 tablet fasted (Period 2), Phase 3 tablet after a high-fat meal (Period 3), and Phase 3 tablet after a low-fat meal (Period 4). Receives: Drug: simufilam
Sequence B	Other	This arm received Phase 3 tablet after a low-fat meal (Period 1), Phase 2 tablet fasted (Period 2), Phase 3 tablet fasted (Period 3), and Phase 3 tablet after a high-fat meal (Period 4). Receives: Drug: simufilam
Sequence C	Other	This arm received Phase 3 tablet fasted (Period 1), Phase 3 tablet after a high-fat meal (Period 2), Phase 3 tablet after a low-fat meal (Period 3), and Phase 2 tablet fasted (Period 4). Receives: Drug: simufilam
Sequence D	Other	This arm received Phase 3 tablet after a high-fat meal (Period 1), Phase 3 tablet after a low-fat meal (Period 2), Phase 2 tablet fasted (Period 3), and Phase 3 tablet fasted (Period 4). Receives: Drug: simufilam

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
The maximum concentration determined directly from individual concentration-time data
Measured: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours
AUClast
Area under the curve to the time of the last quantifiable concentration, calculated using the linear trapezoidal method
Measured: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours
AUCinf
Area under the curve extrapolated to infinity; calculated as: AUCinf = AUClast + Clast/λz
Measured: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 May 202111 May 2021

First posted21 Jun 2021
Study start4 May 2021
Primary completion11 May 2021
Study completion11 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Four-way crossover of Phase 3 tablets under fasted or high-fat or low-fat conditions and the Phase 2 tablet under fasted conditions. Subjects are randomized to a sequence.
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04932655
Sponsor's protocol ID: PTI-125-05
Status last verified: Oct 2022
First submitted: 19 May 2021
Last updated: 22 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Four-way Crossover Food Effect and Bioequivalence Pharmacokinetic Study of Simufilam in Healthy Volunteers
ClinicalTrials.gov ID: NCT04932655
Acronym / sponsor ID: PTI-125-05
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Cassava Sciences, Inc.Industry (pharma, biotech, devices)
Collaborators: Worldwide Clinical Trials
Study start: 4 May 2021 (actual)
Primary completion: 11 May 2021 (actual)
Study completion: 11 May 2021 (actual)
First posted: 21 Jun 2021 (actual)
Results: Posted 22 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model description: Four-way crossover of Phase 3 tablets under fasted or high-fat or low-fat conditions and the Phase 2 tablet under fasted conditions. Subjects are randomized to a sequence.

Arm	Type	Receives
Sequence A	Other	Drug: simufilamThis arm received Phase 2 tablet fasted (Period 1), Phase 3 tablet fasted (Period 2), Phase 3 tablet after a high-fat meal (Period 3), and Phase 3 tablet after a low-fat meal (Period 4).
Sequence B	Other	Drug: simufilamThis arm received Phase 3 tablet after a low-fat meal (Period 1), Phase 2 tablet fasted (Period 2), Phase 3 tablet fasted (Period 3), and Phase 3 tablet after a high-fat meal (Period 4).
Sequence C	Other	Drug: simufilamThis arm received Phase 3 tablet fasted (Period 1), Phase 3 tablet after a high-fat meal (Period 2), Phase 3 tablet after a low-fat meal (Period 3), and Phase 2 tablet fasted (Period 4).
Sequence D	Other	Drug: simufilamThis arm received Phase 3 tablet after a high-fat meal (Period 1), Phase 3 tablet after a low-fat meal (Period 2), Phase 2 tablet fasted (Period 3), and Phase 3 tablet fasted (Period 4).

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Male or female subjects, Ages ≥ 18 and ≤ 45 years
BMI of 18 - 30 Kg/m²
Informed consent form (ICF) signed by the subject
General health status acceptable for participation in the study as determined by medical history, review of current medication, physical examination, and laboratory results
Fluency (oral and written) in English

Key exclusion criteria (13 listed)

The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
The subject has had a clinically significant illness within 30 days of this study.
The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
Subject is taking prescription CNS medication.
The subject has used alcohol, grapefruit, grapefruit juice, caffeine or xanthinecontaining products 48 h before dosing or intends to use any of these products during the study.

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
simufilamAlso: PTI-125Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.	Drug	Sequence A, Sequence B, Sequence C, Sequence D

Primary outcome

Cmax
Time frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours
The maximum concentration determined directly from individual concentration-time data
AUClast
Time frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours
Area under the curve to the time of the last quantifiable concentration, calculated using the linear trapezoidal method
AUCinf
Time frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours
Area under the curve extrapolated to infinity; calculated as: AUCinf = AUClast + Clast/λz

Results and safety

Results posted to the registry on 22 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence A	6	6
Sequence B	6	6
Sequence C	6	6
Sequence D	6	6

Primary outcome: Cmax

Time frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	Fasted Phase 3 Simufilam n = 24	Phase 3 High-fat Fed Simufilam n = 24	Phase 3 Low-fat Fed Simufilam n = 24	Fasted Phase 2 Simufilam n = 24
Value	698 (190)	715 (156)	755 (149)	680 (193)

Fasted Phase 3 Simufilam vs Phase 3 High-fat Fed Simufilam: Test/Reference Ratio of Geometric Means: 103.22 (90% CI 96.88 to 109.98)
Fasted Phase 3 Simufilam vs Phase 3 Low-fat Fed Simufilam: Test/Reference Ratio of Geometric Means: 109.64 (90% CI 102.9 to 116.82)
Fasted Phase 3 Simufilam vs Fasted Phase 2 Simufilam: Test/Reference Ratio of Geometric Means: 102.90 (90% CI 96.57 to 109.64)

Primary outcome: AUClast

Time frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Fasted Phase 3 Simufilam n = 24	Phase 3 High-fat Fed Simufilam n = 24	Phase 3 Low-fat Fed Simufilam n = 24	Fasted Phase 2 Simufilam n = 24
Value	3890 (1050)	3810 (951)	3830 (971)	3860 (978)

Fasted Phase 3 Simufilam vs Phase 3 High-fat Fed Simufilam: Test/Reference Ratio of Geometric Means: 98.47 (90% CI 96.33 to 100.65)
Fasted Phase 3 Simufilam vs Phase 3 Low-fat Fed Simufilam: Test/Reference Ratio of Geometric Means: 98.88 (90% CI 96.74 to 101.07)
Fasted Phase 3 Simufilam vs Fasted Phase 2 Simufilam: Test/Reference Ratio of Geometric Means: 100.32 (90% CI 98.15 to 102.54)

Primary outcome: AUCinf

Time frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Fasted Phase 3 Simufilam n = 24	Phase 3 High-fat Fed Simufilam n = 24	Phase 3 Low-fat Fed Simufilam n = 24	Fasted Phase 2 Simufilam n = 24
Value	3980 (1130)	3900 (1030)	3930 (1050)	3960 (1060)

Fasted Phase 3 Simufilam vs Phase 3 High-fat Fed Simufilam: Test/Reference Ratio of Geometric Means: 98.50 (90% CI 96.33 to 100.71)
Fasted Phase 3 Simufilam vs Phase 3 Low-fat Fed Simufilam: Test/Reference Ratio of Geometric Means: 99.03 (90% CI 96.85 to 101.26)
Fasted Phase 3 Simufilam vs Fasted Phase 2 Simufilam: Test/Reference Ratio of Geometric Means: 100.25 (90% CI 98.05 to 102.50)

Adverse events

Time frame: 8 days. Other adverse events reported at 4.17% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fasted Phase 3 Simufilam	0 of 24 (0%)	4 of 24 (16.7%)	0 of 24
Phase 3 High-fat Fed Simufilam	0 of 24 (0%)	4 of 24 (16.7%)	0 of 24
Phase 3 Low-fat Fed Simufilam	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24
Fasted Phase 2 Simufilam	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Healthy Volunteers

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

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.

Robert G Bass, MD principal investigator

Worldwide Clinical Trials

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing simufilam in people with Healthy Volunteers, run by Cassava Sciences, Inc. at 1 site in United States.

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 7 inclusion and 13 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 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 22 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours). The study lists 3 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 NCT04932655.

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 22 Aug 2023.