Healthy Volunteer
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of single and multiple orally ascending doses of GDC-0310 administered in healthy participants as 4 parts including Part 1- a single dose (SD) part using a powder-in-capsule (PIC) formulation, Part 2- a multiple dose (MD) part using a PIC formulation, Part 3- a SD part using a solution formulation, and Part 4- a MD part using a solution formulation. Effects of food on pharmacokinetics (PK) will also be explored.
Interventions
DRUGGDC-0310
Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.
DRUGPlacebo
Participants will receive placebo matched to GDC-0310 as single or multiple oral dose in fasted or fed state.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female participants of non-childbearing potential must meet the criteria defined in the protocol * Body mass index within the range of 18.0 to 30.0 kilograms per meter square (kg/m\^2), inclusive, and a minimum weight of 50.0 kg
Exclusion criteria
* Have a clinically significant medical condition (e.g., hypertension; diabetes; impaired cardiac, renal or hepatic function; hyperthyroidism or hypothyroidism; neurological disorder; pain condition; hematologic disorder; psychiatric disorders requiring chronic medication) including any medical condition requiring treatment with medication (other than study drugs and medications specifically allowed by this protocol) during participation in the study * Evidence of any hepatic impairment including any abnormal levels (i.e., greater than \[\>\] 1 × the upper limit of normal) of alkaline phosphatase, gamma glutamyl transpeptidase, alanine transaminase, aspartate aminotransferase or bilirubin * Evidence of clinically significant renal impairment defined as \>1.3 × upper limit of normal creatinine * History or presence of alcoholism or alcohol or substance abuse (not including nicotine or caffeine) within the previous 2 years or routinely consume 2 or more alcohol-containing beverages per day or more than 10 units of alcohol per week (1 unit =150 milliliter (mL) of wine, 360 mL of beer, or 45 mL of 40 percent (%) alcohol) * Have a positive urine drug test at screening or check-in or any other point during the study * Are habituated to analgesic drugs (i.e., routine use of oral analgesics 5 or more times per week) or have a history of chronic pain requiring opiate use * Have used tobacco or nicotine-containing products within 3 months before study drug administration * Have clinically significant abnormal laboratory values as determined by the principal investigator * Have used any prescription or over-the-counter medication or supplement within 14 days or 5 times the elimination half-life (whichever is longer) before administration of study drug and until the end of their participation in the study * History of seizures, including in first degree relatives * History of heritable myopathy, weakness, or paralysis, including in first degree relatives indicative of familial periodic paralysis * Current treatment with medications that are well known to prolong the QT interval
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) | Baseline up to Month 9 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Plasma Concentration (Cmin) of GDC-0310 | Pre dose up to Day 15 (detailed timeframe has been reported in the description) | SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15 |
| Time to Maximum Plasma Concentration (tmax) of GDC-0310 | Pre dose up to Day 15 (detailed timeframe has been reported in the description) | SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15 |
| Area Under the Concentration-Time Curve (AUC) of GDC-0310 | Pre dose up to Day 15 (detailed timeframe has been reported in the description) | SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15 |
| Apparent Clearance (CL/F) of GDC-0310 | Pre dose up to Day 15 (detailed timeframe has been reported in the description) | SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15 |
| Apparent Terminal Volume of Distribution (Vz/F) of GDC-0310 | Pre dose up to Day 15 (detailed timeframe has been reported in the description) | SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15 |
| Maximum Plasma Concentration (Cmax) of GDC-0310 | Pre dose up to Day 15 (detailed timeframe has been reported in the description) | SD Cohort: Pre-dose (PD) (Hour\[H\] 0),5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H post-dose(PoD); MD Cohort:PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14;Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15 |
| Apparent Terminal Half-Life (t1/2) of GDC-0310 | Pre dose up to Day 15 (detailed timeframe has been reported in the description) | SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15 |
| Pharmacokinetics (PK) Dose Proportionality as Assessed With Cmax of GDC-0310 | Pre dose up to Day 15 (detailed timeframe has been reported in the description) | SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15 |
| PK Dose Proportionality as Assessed With AUC of GDC-0310 | Pre dose up to Day 15 (detailed timeframe has been reported in the description) | SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15 |
| Accumulation Ratio for MD Cohort | Pre dose up to Day 15 (detailed timeframe has been reported in the description) | PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15 |
| Apparent Terminal Elimination Rate Constant (ke) of GDC-0310 | Pre dose up to Day 15 (detailed timeframe has been reported in the description) | SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15 |
Countries
United States
Outcome results
None listed