A study to evaluate the safety and the processing of GDC-0829 by the body in healthy participants

A Phase I, randomized, double-blind, single ascending dose and multiple ascending dose study to evaluate the safety and pharmacokinetics of GDC-0829 in healthy subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18049481

Enrollment

104

Registered

2024-01-19

Start date

2024-04-12

Completion date

Unknown

Last updated

2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers Other

Interventions

Participants will be randomized according to a master randomization list generated by the study Biostatistician in the KLD system. Participants will be randomly assigned to GDC-0829 or placebo in a 3:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 - 65 years at the time of signing the Informed Consent Form 2. Body mass index (BMI) =18.5 and <30 kilograms per metre squared (kg/m^2) 3. Ability to comply with the 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. SAD: Number of participants with adverse events (AEs), with severity of AEs determined according to the Division of AIDS (DAIDS) toxicity grading scale, corrected version 2.1, July 2017 for most AEs and according to modified Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale from Screening up to 14 days after the final dose of study drug (up to approximately 15 days) 2. MAD: Number of participants with AEs, with severity of AEs determined according to the DAIDS toxicity grading scale, corrected version 2.1, July 2017 for most AEs and according to modified CTCAE version 5.0 grading scale from screening up to 28 days after the final dose of study drug (up to approximately 38 days)	—

Measure

Time frame

1. SAD: Number of participants with adverse events (AEs), with severity of AEs determined according to the Division of AIDS (DAIDS) toxicity grading scale, corrected version 2.1, July 2017 for most AEs and according to modified Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale from Screening up to 14 days after the final dose of study drug (up to approximately 15 days) 2. MAD: Number of participants with AEs, with severity of AEs determined according to the DAIDS toxicity grading scale, corrected version 2.1, July 2017 for most AEs and according to modified CTCAE version 5.0 grading scale from screening up to 28 days after the final dose of study drug (up to approximately 38 days)

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Secondary

Measure	Time frame
1. SAD: Plasma concentration of GDC-0829 measured using blood samples collected at pre-dose and multiple timepoints post-dose from Day 1 to Day 15 2. SAD: Urine concentration of GDC-0829 measured using urine samples collected at pre-dose and multiple timepoints post-dose from Day -1 to Day 3 3. MAD: Plasma concentration of GDC-0829 measured using blood samples collected at pre-dose and multiple timepoints post-dose from Day 1 to Day 38 4. MAD: Urine concentration of GDC-0829 measured using urine samples collected at multiple timepoints post-dose on Day 11	—

Measure

Time frame

1. SAD: Plasma concentration of GDC-0829 measured using blood samples collected at pre-dose and multiple timepoints post-dose from Day 1 to Day 15 2. SAD: Urine concentration of GDC-0829 measured using urine samples collected at pre-dose and multiple timepoints post-dose from Day -1 to Day 3 3. MAD: Plasma concentration of GDC-0829 measured using blood samples collected at pre-dose and multiple timepoints post-dose from Day 1 to Day 38 4. MAD: Urine concentration of GDC-0829 measured using urine samples collected at multiple timepoints post-dose on Day 11

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Countries

United States of America

Contacts

Public ContactClinical Trials

global-roche-genentech-trials@gene.com+1 (0)888 662 6728

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026