Safety and pharmacokinetics?of single doses of GDC-5780 in healthy participants Not Applicable
Conditions
Interventions
1. GDC-5780 – Single Ascending Dose: Participants will receive a single dose of GDC-5780 as intravenous (IV) infusion over 2 hours on Day 1 in the first cohort. The dose will be escalated in subsequen
Sponsors
Roche (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Body mass index? =18.5 and <30 kg/m² 2. Body temperature of 35°C-37.6°C at screening 3. Systolic blood pressure of 90-139 mmHg and diastolic blood pressure of? 45-89 mmHg at screening 4. Agree to abstain from consumption of grapefruit, grapefruit hybrids, oranges, orange hybrids, pomelos, exotic citrus fruits, and all orange and grapefruit-type fruit juices from 48 hours prior to check-in until clinic check-out (i.e., end of residential stay) 5. Agree to abstain from consumption of alcohol from 48 hours prior to clinic?check-in until clinic check-out 6. Agreement to abstain from consumption of caffeine-containing foods and beverages?(e.g., coffee, tea, chocolate, energy drinks, soda) from 48 hours prior to clinic check-in until clinic check-out
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 14 days after the dose of study drug 2. Planned procedure or surgery during the study 3. Clinical laboratory values outside the normal reference range for the test laboratory at screening, Day?-2, or Day?-1. Participants with an estimated glomerular filtration rate <90 mL/min/1.73 m² at screening, Day?-2, or Day?-1, as calculated using the Chronic Kidney Disease Epidemiology Collaboration equation, must be excluded from the study 4. Positive HIV test at screening 5. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis B virus (HBV) DNA test at screening, hepatitis C virus (HCV) 6. Urine sample positive for drugs of abuse at screening or Day?-2 7. Treatment with investigational biologic therapy within 90 days?or 5 drug elimination?half-lives (if known), whichever is longer, prior to initiation of study drug 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. Percentage of participants with?adverse events (AEs) measured from Day 1?until 14? days after the dose of study drug 2. Percentage of participants with?adverse events based on?severity per Division of AIDS (DAIDS) Toxicity Grading Scale from Day 1?until?14 days after the?dose of study drug 3. Percentage of participants with clinically significant change in vital signs measured using body temperature, respiratory rate, pulse rate, and blood pressure from?Day 1 until 14 days after the?dose of study drug 4. Percentage of participants with clinically significant laboratory test abnormalities measured using blood and urine samples from?Day 1?until?14 days after the dose of study drug 5. Percentage of participants with clinically significant?electrocardiogram (ECG) abnormalities measured using single 12-lead ECG or Holter ECG recordings from Day 1?until?14 days after the?dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maximum observed plasma concentration (Cmax) of GDC-5780 measured from blood samples taken at multiple timepoints over Days 1, 2, 3, and 4 2. Time to reach maximum plasma concentration (Tmax) of GDC-5780, measured from blood samples taken at multiple timepoints over Days 1, 2, 3, and 4 3. Terminal half-life (t1/2) of GDC-5780 measured from blood samples taken at multiple timepoints over Days 1, 2, 3, and 4 4. Area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC (0-24)) with GDC-5780 measured from blood samples taken at multiple timepoints over Days 1, 2, 3, and 4 5. Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUC (0-last)) of GDC-5780 measured from blood samples taken at multiple timepoints over Days 1, 2, 3, and 4 6. Area under the plasma concentration-time curve from time zero to infinity (AUC (0-infinity)) of GDC-5780 measured from blood samples taken at multiple timepoints over Days 1, 2, 3, and 4 7. Renal clearance (CLr) measured from multiple pooled urine samples taken at multiple timepoints from Day 1 to Day 4 8. Fractional excretion of GDC-5780 measured from multiple pooled urine samples taken at multiple timepoints from Day 1 to Day 4 | — |
Countries
United States of America
Contacts
Public ContactClinical Trials?
Outcome results
None listed