Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Simufilam Following a Single Oral Dose in Healthy Male Subjects
NCT06195319 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2025-03-20
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
Interventions
- DRUG
-
Simufilam
100 mg of \[14C\]-simufilam
Sponsors & Collaborators
-
Cassava Sciences, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-02-07
- Primary Completion
- 2024-03-27
- Completion
- 2024-03-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male Subjects
NCT05657834 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers
NCT03795519 ·Status: COMPLETED ·Phase: PHASE1
-
A Metabolite Identification, Mass Balance, and PK Study of [14C]-Asimadoline to Healthy Adult Male Volunteers
NCT01380561 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled Risdiplam (RO7034067) in Healthy Male Participants
NCT03036501 ·Status: COMPLETED ·Phase: PHASE1
-
Absorption, Metabolism and Excretion of [14C]-Lasmiditan - Single Oral Dose Administration
NCT03040362 ·Status: COMPLETED ·Phase: PHASE1
-
Absorption, Distribution, Metabolism and Excretion of [14C] Labelled BIA 5-1058
NCT04069130 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of (14C) Radiolabeled JNJ-56136379 in Healthy Male Participants
NCT03864601 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Drug Levels of [14C]CC-99677 in Healthy Male Participants
NCT05284890 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
NCT05578859 ·Status: COMPLETED ·Phase: PHASE1
-
Metabolism and Excretion of [14C]CC-90001 in Healthy Male Subjects
NCT04655898 ·Status: COMPLETED ·Phase: PHASE1
-
The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers
NCT04810533 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6
NCT06325930 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Look at How a Single Oral Dose of Carbon-14-Labelled [14C] BIIB091 Moves Through and is Processed by the Body in Healthy Male Participants
NCT06311786 ·Status: COMPLETED ·Phase: PHASE1
-
14-C ADME (Absorption, Disposition, Metabolism and Excretion) Study in Man
NCT01176201 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Metabolism and Excretion of BMS-986369 in Healthy Male Participants
NCT05567510 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Determine the Absorption, Metabolism, and Excretion of [14C]LX4211 in Healthy Male Subjects
NCT01818232 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants
NCT05981963 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB086550
NCT05101369 ·Status: COMPLETED ·Phase: PHASE1
-
Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects
NCT04415645 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose
NCT02571192 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293
NCT02126514 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants
NCT06309394 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants
NCT06301971 ·Status: COMPLETED ·Phase: PHASE1
-
CC100: Safety and Tolerability of Single Doses
NCT02050334 ·Status: COMPLETED ·Phase: PHASE1
-
Mass Balance Study of [14C]-NT-814 Oral Suspension in Healthy Male Subjects
NCT04654897 ·Status: COMPLETED ·Phase: PHASE1