Renal cell carcinoma cancer Renal cell carcinoma
Conditions
Interventions
Part 1:
The volunteer will be given AB521 or placebo as oral capsules with 240
milliliters (mL) of (tap) water.
Part 2:
If the volunteer participates in group 1 it will receive on day 1 to 7 AB521
Sponsors
Arcus Biosciences, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Participant must be at least 18 to 55 years of age inclusive, at the time of signing the informed consent. 3. Participants who are healthy volunteers (in the opinion of the investigator) as determined by pre-study medical history, physical examination, vital signs, and 12-lead ECG. 4. Participants must have clinical laboratory tests within the reference range for age and gender at screening and baseline. 5. Screening and randomization hemoglobin for males and females is as follows: a) SAD: male and female hemoglobin level >= 12.5 g/dL (7.7 mmol/L) b) MAD and DDI: male hemoglobin level >= 14.2 g/dL (8.8 mmol/L) and female hemoglobin level >= 12.5 g/dL (7.7 mmol/L). Further criteria apply
Exclusion criteria
Exclusion criteria: 1. Has any (acute or chronic [including SARS-CoV-2 infection]) medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant*s ability to participate in this study. 2. Has history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, cerebrovascular, neurological, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of IMP; constituting a risk when taking the study intervention; or interfering with the interpretation of data in the opinion of the investigator. 3. Abnormal blood pressure (BP) or pulse measurements at the Screening Visit or Day -2/-1 (Admission) in a supine position after 5 minutes of rest as follows: mean systolic BP >= 139 mm Hg or mean diastolic BP >= 89 mm Hg; mean pulse 100 bpm. Study participants with a BP within normal range but who, in the opinion of the investigator, have a high risk for cardiovascular accident based on, eg, family history, smoking, BMI, or lipid spectrum can be excluded. Results that are outside the specified ranges and are deemed clinically non-significant will be allowed at the discretion of the investigator, after discussion with the Sponsor Medical Monitor (or designee). If a study participant has a test result outside the normal range that is deemed potentially clinically significant, repeat of the investigation may be allowed once at the discretion of the investigator, after discussion with the Sponsor Medical Monitor (or designee). 4. The following liver enzyme test results: a) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, or alkaline phosphatase (ALP) >1.0× upper limit of normal (ULN). • Tests that result in ALT, AST, bilirubin, or ALP up to 25% above the exclusion limit may be repeated once for confirmation. b) Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones). 5. Has 12-lead ECG with changes considered to be clinically significant (eg, QTcF > 450 msec for males and > 470 msec for females, left bundle branch block, or evidence of myocardial ischemia) at the Screening Visit or Day -2/-1 (Admission). Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To assess the safety and tolerability of AB521 after single- and multiple oral doses. - To characterize the PK profile of AB521 after single- and multiple oral doses. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate the effect of multiple oral doses of AB521 on the PK of midazolam when midazolam is administered as a single dose Exploratory: - To assess the potential PD effects of AB521 - To characterize AB521 excretion in urine - To characterize potential metabolite(s) of AB521 in plasma and urine | — |
Countries
Netherlands
Outcome results
None listed