Healthy volunteers Not Applicable
Conditions
Interventions
Randomization
A Block randomization method is used to generate a master randomization list. The sentinel subjects and remainder subjects are randomized separately, where the sentinel subjects have a 2
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 - 65 years at time of signing informed consent form (ICF) 2. Body mass index (BMI) of = 18.5 and < 30 kilograms per metre squared (kg/m^2) at screening 3. Ability to comply with study protocol
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of study drug 2. Planned procedure or surgery during the study 3. Positive human immunodeficiency virus (HIV) test at screening 4. Positive hepatitis B surface antigen (HBsAg) test at screening 5. Positive hepatitis C virus (HCV) antibody test at screening 6. Any serious medical condition or abnormality in clinical laboratory tests 7. History of malignancy within 5 years prior to screening 8. Acute illness within 14 days prior to screening 9. Vaccination within 14 days prior to initiation of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence and severity of adverse events (AEs), with severity determined according to the Division of AIDS (DAIDS) toxicity grading scale and a modified Common Terminology Criteria for Adverse Events (CTCAE) grading scale for infusion related reactions, measured using data from electronic Case Report Forms (eCRFs) from initiation of the study up to Day 38 2. Incidence and severity of vital sign, laboratory test, and electrocardiogram (ECG) abnormalities measured using data from vital signs recorded (respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature), laboratory test results (serum/plasma/urine samples), and ECG readings (single 12-lead ECG recordings) from initiation of study to 28 days after the last dose (up to Day 38). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maximum plasma concentration (Cmax) of GDC-5780 measured using plasma samples collected at multiple timepoints post-dose on Day 1 2. Maximum plasma concentration at steady state (Cmax,ss) of GDC-5780 measured using plasma samples collected at multiple timepoints post-dose on Day 10 3. Time to maximum observed concentration (tmax) of GDC-5780 measured using plasma samples collected at multiple timepoints post-dose on Day 1 4. Area under the concentration-time curve from time 0 to t (AUC0- t) of GDC-5780 measured using plasma samples collected at multiple timepoints post-dose on Day 1 5. Area under the concentration-time curve at steady state (AUC0- t,ss) of GDC-5780 measured using plasma samples collected at multiple timepoints post-dose on Day 10 6. Lowest plasma concentration prior to next dose (Ctrough) of GDC-5780 measured using plasma samples collected prior to first infusion on Days 2-9 7. Terminal half-life (t1/2) of GDC-5780 measured using plasma samples collected at multiple timepoints post-dose from Day 10 up to Day 24 8. Fractional excretion (Fe) of GDC-5780 measured using pooled urine samples collected at post-dose timepoints on Day 10 9. Renal clearance (CLr) of GDC-5780 measured using pooled urine samples collected at post-dose timepoints on Day 10 | — |
Countries
United States of America
Contacts
Public ContactClinical Trials
Outcome results
None listed