Healthy Participants
Conditions
Keywords
AB680, Quemliclustat, Pharmacokinetics
Brief summary
The purpose of the study is to investigate the routes of elimination and overall mass balance of 100 mg quemliclustat containing 75 μCi \[14C\] following a single IV infusion of \[14C\]-quemliclustat in healthy adult male participants, and to quantify total radioactivity (TRA) in plasma, whole blood, urine, and feces.
Interventions
DRUGQuemliclustat
Administered as specified in the treatment arm
Sponsors
Arcus Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, standard vital signs, and ECGs, as deemed by the PI or designee. * Participants must follow protocol-specified contraception guidance. * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the start of infusion based on participant self-reporting. * BMI ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit. * Understands the study procedures in the Informed Consent Form and is willing and able to comply with the protocol.
Exclusion criteria
* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. * History or presence of clinically significant medical, surgical, or psychiatric condition or disease in the opinion of the PI or designee. * History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study. * History or presence of alcohol or drug abuse within the past 2 years prior to the start of infusion. * History of presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of total radioactivity excreted in urine and feces | Up to 40 days |
| Total radioactivity in blood | Up to 40 days |
| Total radioactivity in plasma | Up to 40 days |
| Excretion of total radioactivity in urine | Up to 40 days |
| Excretion of total radioactivity in feces | Up to 40 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to 54 days |
| Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last]) for quemliclustat | Up to 40 days |
| Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf]) for quemliclustat | Up to 40 days |
| Maximum Observed Plasma Concentration (Cmax) for quemliclustat | Up to 40 days |
| Elimination Half-life (t1/2) for quemliclustat | Up to 40 days |
| Excretion of quemliclustat in urine | Up to 40 days |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Arcus Biosciences
Outcome results
None listed