Healthy VolunteerPhase 1NCT03188783
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Participants
A Phase 1 study testing GDC-0853 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- GDC-0853
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2017to 9 Aug 2017
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trials
Cypress, California, 90630
About this study
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
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.
Read the detailed 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.
- Conditions
- Healthy Volunteer
- Being tested
- GDC-0853, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0853Drug
GDC-0853 tablets orally, either a single dose or twice-daily.
PlaceboDrug
GDC-0853 matching placebo tablets orally, either a single dose or twice-daily.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: GDC-0853 Low Dose | Experimental | Japanese subjects will receive a single low dose of GDC-0853 or matching placebo by mouth. Receives: Drug: GDC-0853; Drug: Placebo |
| Cohort 2: GDC-0853 Intermediate Dose | Experimental | Japanese subjects will receive a single intermediate dose of GDC-0853 or matching placebo by mouth. Subsequently, participants will receive twice-daily intermediate doses of GDC-0853 or matching placebo by mouth for 4 days followed by a single intermediate dose of GDC-0853 or matching placebo by mouth. Receives: Drug: GDC-0853; Drug: Placebo |
| Cohort 3: GDC-0853 Intermediate Dose | Experimental | Caucasian subjects will receive a single intermediate dose of GDC-0853 or matching placebo by mouth. Subsequently, participants will receive twice-daily intermediate doses of GDC-0853 or matching placebo by mouth for 4 days followed by a single intermediate dose of GDC-0853 or matching placebo by mouth. Receives: Drug: GDC-0853; Drug: Placebo |
| Cohort 4: GDC-0853 Low Dose | Experimental | Japanese subjects will receive a single high dose of GDC-0853 or matching placebo by mouth. Receives: Drug: GDC-0853; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Cohorts 1 and 4: up to Day 29; Cohorts 2 and 3: up to Day 36
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.
Measured: Cohorts 1 and 4: up to Day 29; Cohorts 2 and 3: up to Day 36
Secondary outcomes (3)
Maximum Observed Plasma Concentration (Cmax) of GDC-0853
Cmax is the maximum observed plasma concentration.
Measured: Predose and up to 72 hours postdose
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.
Measured: Predose and up to 72 hours postdose
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.
Measured: Predose and up to 72 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start24 Jan 2017
- Primary completion9 Aug 2017
- Study completion9 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188783
- Sponsor's protocol ID
- GP39851
- Status last verified
- Aug 2019
- First submitted
- 14 Jun 2017
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No