A Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 2/24/2019 |
Start Date: | September 15, 2015 |
End Date: | June 7, 2017 |
A Phase I, Randomized, Single and Multiple Ascending Dose, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers
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.
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.
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
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