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AbsorptionPhase 1NCT06195319

Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Simufilam Following a Single Oral Dose in Healthy Male Subjects

A Phase 1 study testing Simufilam in people with Absorption and Metabolism, 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
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Trial summary

To evaluate the absorption, metabolism, and excretion of [14C]-simufilam in healthy male subjects following a single oral administration of 100 mg of (approximately 100 µCi) [14C]-simufilam. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Absorption, Metabolism, Excretion
What is being tested?
Simufilam
How many people
8 participants
Where
1 siteUnited States
Study dates
7 Feb 2024to 27 Mar 2024
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 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males of any race, between 18 and 55 years of age, inclusive.
  • The subject has a body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, and a total body weight between 50 and 110 kg, inclusive.
  • In good health, determined by no clinically significant findings from medical history, physical examination (at both screening and check-in), vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations (at both screening and check-in) as assessed by the Investigator (or designee).
  • The subject is able to speak, read, and understand English and is willing to provide written informed consent.
  • The subject is a non-smoker for the past 6 months.
  • Must agree to use contraception History of a minimum of 1 bowel movement per day.
  • The subject is willing and able to comply with all testing and requirements defined in the protocol.
  • The subject must have completed a coronavirus disease (COVID-19) vaccine primary series ("fully vaccinate") at least 4 weeks prior to inpatient treatment day 1 of the study OR have COVID-19 virus serology consistent with prior vaccination or exposure.

Who cannot join

  • The subject has had a clinically significant illness within 30 days prior to the Screening Visit.
  • The subject has a significant history or clinical manifestation of any allergic, cardiovascular, dermatological, endocrine, gastrointestinal, hepatic, metabolic, neurological, psychiatric, pulmonary, renal, respiratory, or psychiatric disorder, as determined by the Investigator (or designee).
  • The subject has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). A history of a cholecystectomy is exclusionary.
  • Confirmed (e.g., 2 consecutive measurements) systolic blood pressure > 140 or < 90 mmHg, diastolic blood pressure > 90 or < 50 mmHg, and pulse rate > 100 or < 40 beats per minute. Minor deviations from the normal range may be allowed if deemed by the Investigator (or designee) to have no clinical significance.
  • The subject has a clinically significant electrocardiogram (ECG) abnormality as evaluated by the Investigator (or designee).
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  • The subject has a clinically significant medical or laboratory abnormality or disease that, in the opinion of the investigator, should exclude the subject from the study, including:
  • a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or alkaline phosphatase (ALP) outside of the normal range at screening.
  • Evidence of renal impairment (GFR < 90 mL/min/1.73m2 using the National Kidney Foundation CKD-EPI 2021 Creatinine Equation [9].
  • Presence of congenital nonhemolytic hyperbilirubinemia (i.e., Gilbert's syndrome based on an assessment of total and direct bilirubin).
  • The subject has a positive serum hepatitis B surface antigen test at the Screening Visit.
  • The subject has or has had hepatitis C, as confirmed by a positive hepatitis C virus (HCV) antibody test at the Screening Visit.
  • The subject has a positive human immunodeficiency virus (HIV) test at the Screening Visit
  • The subject has been administered any vaccine in the 14-day period prior to dosing.
  • The subject has used or intends to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 28 days prior to dosing, unless deemed acceptable by the Investigator (or designee) and Medical Monitor, in consultation with the Sponsor.
  • The subject has used or intends to use any prescription medication within 14 days of dosing or over the counter (OTC) medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 48 hours of dosing and during the study unless deemed acceptable by both the Investigator (or designee) and Medical Monitor, in consultation with the Sponsor.
  • The subject has used or intends to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the Investigator (or designee).
  • The subject has received an investigational drug within 30 days prior to the Screening Visit.
  • The subject has previously received simufilam.
  • The subject has participated in ≥ 3 radiolabeled drug studies in the last 12 months (with most recent study to be at least 4 months prior to check-in to the study site where exposures are known to the investigator or 6 months prior to check-in to the study site for a radiolabeled drug study where exposures are not known to the investigator). The total 12-month exposure from this study and a maximum of 2 other previous radiolabeled studies within 4 to 12 months prior to this study will be within the Code of Federal Regulations (CFR) recommended levels considered safe, per United States (US) Title 21 CFR 361.1.
  • The subject has a history of substance abuse within 12 months of the Screening Visit or a current positive alcohol urine test or urine drug screen at the Screening Visit or at check-in.
  • The subject has a history of regular alcohol consumption defined as greater than 14 drinks per week within six months prior to the Screening Visit. One drink is equivalent to 12 g alcohol = 5 oz (150 mL) of wine or 12 oz (360 mL) of beer or 1.5 oz (45 mL) of 80 proof distilled spirits.
  • The subject has used tobacco- or nicotine-containing products within 6 months prior to dosing or has a positive cotinine test at the Screening Visit or at check-in.
  • The subject has consumed alcohol, caffeine, grapefruit, grapefruit juice, or xanthine-containing products within 72 hours before dosing or intends to use any of these products during the study.
  • The subject has received blood products within 2 months prior to check-in.
  • The subject has donated or lost a significant volume of blood (>500 mL) within a 90- day period prior to the Screening Visit or has donated plasma less than 2 weeks or platelets less than 6 weeks prior to the Screening Visit.
  • The subject is unwilling to reside in the study unit for the duration of the study or unwilling to cooperate fully with the Investigator or site personnel.
  • Subjects with poor peripheral venous access.
  • Subjects with exposure to significant diagnostic or therapeutic radiation (e.g., serial x-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
  • Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fortrea

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Simufilam Following a Single Oral Dose in Healthy Male Subjects

To evaluate the absorption, metabolism, and excretion of [14C]-simufilam in healthy male subjects following a single oral administration of 100 mg of (approximately 100 µCi) [14C]-simufilam.

Being tested
Simufilam

What participants receive

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

  • SimufilamDrug

    100 mg of [14C]-simufilam

What is being measured

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

  1. AUC of total radioactivity, parent drug and metabolite(s) in plasma.

    Area Under the Curve for each total radioactivity, parent drug and metabolite(s) in plasma.

    Measured: 10 days

  2. Cmax of total reactivity, parent drug and metabolite(s) in plasma.

    Maximum concentration for each total radioactivity, parent drug and metabolite(s) in plasma.

    Measured: 10 Days

  3. Tmax of total reactivity, parent drug and metabolite(s) in plasma.

    Time to maximum concentration for each total radioactivity, parent drug and metabolite(s) in plasma.

    Measured: 10 Days

  4. Half-life of total reactivity, parent drug and metabolite(s) in plasma.

    Half-life for each total reactivity, parent drug and metabolite(s) in plasma.

    Measured: 10 Days

  5. Elimination rate constant of total reactivity, parent drug and metabolite(s) in plasma.

    Elimination rate constant for each total reactivity, parent drug and metabolite(s) in plasma.

    Measured: 10 Days

Secondary outcomes (3)

  1. Percentage of total radioactivity recovered versus time.

    Cumulative percentage of the administered radioactive dose recovered in urine, feces, and total excreta (urine and feces combined) versus time profiles.

    Measured: 10 days

  2. Plasma and whole blood concentration of total radioactivity versus time.

    Plasma and whole blood concentration of total radioactivity versus time.

    Measured: 10 Days

  3. Plasma concentration of parent drug and metabolite(s) versus time.

    Plasma concentration of parent drug and metabolite(s) versus time.

    Measured: 10 Days

Timeline

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

  1. First posted8 Jan 2024
  2. Study start7 Feb 2024
  3. Primary completion27 Mar 2024
  4. Study completion27 Mar 2024

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06195319
Sponsor's protocol ID
PTI-125-12
Status last verified
Mar 2025
First submitted
22 Dec 2023
Last updated
20 Mar 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Simufilam in people with Absorption and Metabolism, 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 8 inclusion and 30 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 20 Mar 2025. 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?

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?

AUC of total radioactivity, parent drug and metabolite(s) in plasma. (time frame: 10 days). The study lists 5 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 NCT06195319.

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 20 Mar 2025.

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