A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Participants

Healthy Volunteer Clinical Trial

Official title:

A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188783
• Other study ID #: GP39851
• Status: Completed
• Phase: Phase 1
• Start date: January 24, 2017
• Est. completion date: August 9, 2017

Study information

• Verified date: August 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of GDC-0853 in healthy Japanese and Caucasian subjects.

Description:

This study will be a randomized, placebo-controlled, double-blind, single and multiple dose study. Approximately 32 healthy subjects will be enrolled in 4 discrete cohorts with 8 subjects per cohort.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 9, 2017
• Est. primary completion date: August 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Japanese subjects must have both Japanese parents and all grandparents who were born in a Japanese country of origin

• Caucasian subjects must have 4 Caucasian grandparents (Hispanics of white race can be considered Caucasians)

• Within body mass index range of 18 to 31 kilograms per square meter, inclusive

• Females will be non-pregnant, non-lactating, and either postmenopausal or surgically sterile

• Males will either be sterile or agree to use an approved method of contraception

Exclusion Criteria:

• Significant history or clinical manifestation of any significant metabolic, allergic/immunologic/immunodeficiency, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the investigator)

• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator

• Participation in any other investigational study drug trial in which receipt of any investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check in

• History of malignancy, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma with 3-year disease-free follow up

• Any acute or chronic condition or any other reason that, in the opinion of the investigator, would limit the participant's ability to complete and/or participate in this clinical study

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• GDC-0853
GDC-0853 tablets orally, either a single dose or twice-daily.
• Placebo
GDC-0853 matching placebo tablets orally, either a single dose or twice-daily.

Locations

Country	Name	City	State
United States	West Coast Clinical Trials	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as adverse events. A SAE is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe.	Cohorts 1 and 4: up to Day 29; Cohorts 2 and 3: up to Day 36
Primary	Number of Participants with Clinical Significant Change in Vital Sign, Physical Examination Findings, Clinical Laboratory Results and Electrocardiograms (ECGs)	Number of participants with clinical significant change in vital sign, physical examination findings, clinical laboratory results and electrocardiograms (ECGs) will be reported.	Cohorts 1 and 4: up to Day 29; Cohorts 2 and 3: up to Day 36
Secondary	Maximum Observed Plasma Concentration (Cmax) of GDC-0853	Cmax is the maximum observed plasma concentration.	Predose and up to 72 hours postdose
Secondary	Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Post-dose (AUC0-48) of GDC-0853	Area under the concentration-time curve from Hour 0 to 48 hours postdose, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations.	Predose and up to 72 hours postdose
Secondary	Area under the plasma concentration-time curve from time zero to time tau over the dosing interval (AUC0-tau)	Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.	Predose and up to 72 hours postdose