A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants

Study Overview
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Brief Summary
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This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: GDC-3280
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is male or female, using highly effective contraception Has a body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive Is in good general health Having signed informed consent, is willing and able to comply with requirements of the study Exclusion Criteria: Does not satisfy all screening criteria per protocol Is employed by or related to any personnel involved in the trial Has any history or condition that per protocol or in the opinion of the investigator could compromise the participant's safety or analysis of results

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: GDC-3280<br>Participants in multiple cohorts and treatment periods will receive single doses of GDC-3280 under fed/fasting conditions. | Drug: GDC-3280<br>* GDC-3280 at various doses, depending on the cohort and treatment period<br>|
| Placebo Comparator: Part A: Placebo<br>Participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions. | Drug: Placebo<br>* Placebo at various doses, depending on the cohort and treatment period<br>|
| Experimental: Part B: GCD-3280<br>Participants in different cohorts will receive GDC-3280 in multiple ascending doses under fed/fasting conditions.\n | Drug: GDC-3280<br>* GDC-3280 at various doses, depending on the cohort and treatment period<br>|
| Placebo Comparator: Part B: Placebo<br>Participants in different cohorts will receive placebo in multiple ascending doses under fed/fasting conditions.\n | Drug: Placebo<br>* Placebo at various doses, depending on the cohort and treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing an adverse event |  | Up to approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) for GDC-3280 |  | Up to 4 days | 
| Time to Cmax (Tmax) for GDC-3280 |  | Up to 4 days | 
| Total serum clearance for GDC-3280 |  | Up to 4 days | 
| Volume of distribution for GDC-3280 |  | Up to 4 days | 
| Elimination half-life for GDC-3280 |  | Up to 4 days | 
| Serum GDC-3280 concentration-time data by dosing group |  | Up to 4 days |