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

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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.


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
We found this trial at
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Salt Lake City, Utah 84106
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Salt Lake City, UT
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