A study to evaluate safety and pharmacokinetics (processing by the body) of single ascending doses of GDC-5780 in healthy participants

Phase 1

• Conditions: Safety and pharmacokinetics?of single doses of GDC-5780 in healthy participants; Not Applicable

• Registration Number: ISRCTN16073754
• Lead Sponsor: Roche (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-09
• Last Update Posted: 21 February 2022
• Study Completion: 2022-08-05

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 56

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified