A Study to Determine the Safety, Tolerability, and Pharma... | NCT02742779

NCT02742779

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-Fat Meal SD Cohort: PIC (Part 1)	Experimental	Participants will receive GDC-0310 single ascending dose based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a high-fat meal after a 8-hour/overnight fast using PIC on Day 1 of the treatment period (5 days) in an additional cohort of Part 1.	Drug: GDC-0310
High-Fat Meal SD Cohort: Solution Formulation (Part 3)	Experimental	Participants will receive GDC-0310 single ascending dose based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a high-fat meal after a 8-hour/overnight fast using solution on Day 1 of the treatment period (5 days) in an additional cohort of Part 3.	Drug: GDC-0310
Low-Fat Meal SD Cohort: PIC (Part 1)	Experimental	Participants will receive GDC-0310 single ascending dose given orally using PIC based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a low-fat meal after an 8-hour/overnight fast using PIC on Day 1 of the treatment period (5 days) in an additional cohort of Part 1.	Drug: GDC-0310
Low-Fat Meal SD Cohort: Solution Formulation (Part 3)	Experimental	Participants will receive GDC-0310 single ascending dose given orally using PIC based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a low-fat meal after an 8-hour/overnight fast using solution on Day 1 of the treatment period (5 days) in an additional cohort of Part 1.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GDC-0310	Drug	Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.	High-Fat Meal SD Cohort: PIC (Part 1) High-Fat Meal SD Cohort: Solution Formulation (Part 3)

Outcomes Module

Measure	Description	Time Frame
Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)		Baseline up to Month 9

Secondary Outcomes

Measure	Description	Time Frame
Maximum Plasma Concentration (Cmax) of GDC-0310	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	Pre dose up to Day 15 (detailed timeframe has been reported in the description)

Eligibility Module

Eligibility Criteria

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