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

NCT06195319 | Completed Phase 1 FDA Drug

• 1 other identifier: PTI-125-12
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Absorption; Metabolism; Excretion

Outcome Measures

Primary Outcomes (5)

• 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.

  10 days

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

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

  10 Days

• 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.

  10 Days

• 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.

  10 Days

• 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.

  10 Days

Secondary Outcomes (3)

• Percentage of total radioactivity recovered versus time.

  10 days

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

  10 Days

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

  10 Days

Interventions

Simufilam DRUG

100 mg of \[14C\]-simufilam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).
• 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.

Sponsors & Collaborators

• Cassava Sciences, Inc.: lead

Study Sites (1)

Fortrea

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

Simufilam

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: February 7, 2024
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

US (1)