Healthy VolunteersPhase 1NCT03381144
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Multiple Ascending Doses of GDC-0334 and the Effect of Food on the Pharmacokinetics of GDC-0334 in Healthy Adult Participants
A Phase 1 study testing GDC-0334 in people with Healthy Volunteers, run by Genentech, Inc. at 1 site in United Kingdom.
Trial summary
This is a randomized, double-blind, placebo-controlled, single-center, three-part study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single and multiple ascending doses of GDC-0334 and the effect of food on the pharmacokinetics of GDC-0334 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GDC-0334
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Dec 2017to 29 Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy males or non-pregnant, non-lactating healthy females. Females may be of non-childbearing potential or childbearing potential. Healthy females of childbearing potential must agree to use a highly effective method of contraception.
- Healthy males must agree to use an adequate method of contraception
- Body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m^2) or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study
Who cannot join
- Participants who have received any investigational medicinal product in a clinical research study within the previous 3 months
- Participants who are study site employees, or immediate family members of a study site or sponsor employee
- Participants who have previously been enrolled in this study. Participants who have enrolled in Part 1 are not permitted to enrol in Parts 2 or 3, and participants who have enrolled in Part 2 are not permitted to enroll in Part 3
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >14 units per week (1 unit = ½ pint beer, 25 milliliters (mL) of 40% spirit or a 125-mL glass of wine)
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 6 parts per million (ppm) at screening or admission
Show all 27Show fewer
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator
- Positive drugs-of-abuse test result at screening or admission
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) results
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <70 milliliters per minute (mL/min) using the Cockcroft-Gault equation
- History of seizure
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder, as judged by the investigator
- Participants with a history of cholecystectomy or gall stones (applies to any regimen where food effect is being explored)
- History of serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of active allergy requiring treatment, as judged by the investigator. History of hayfever is allowed unless it is active.
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days or 5 half-lives, whichever is longer, before investigational medicinal product administration. Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as agreed by the principal investigator and sponsor's medical monitor.
- History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction, at screening or admission
- QT interval corrected using Fridericia's formula (QTcF) > 450 milliseconds (msec) demonstrated by at least two ECGs >30 minutes apart
- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease, coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome
- Current treatment with medications that are well known to prolong the QT interval
- History of dermatographism
- Presence or history of clinically significant skin disorders, as judged by the investigator (Parts 1 and 3 only)
- History of trauma or surgery (laceration repair is not excluded) to the arm but not including wrist or hand injury/surgery (Parts 1 and 3 only)
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical Ltd, Clinical Research Unit
Nottingham, NG11 6JS
About this study
Official title: A Phase I, Randomised, Double-Blind, Placebo-Controlled, Single Centre, 3-Part, Study Designed to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Multiple Ascending Doses of GDC-0334 and the Effect of Food on the Pharmacokinetics of GDC-0334 in Healthy Adult Subjects
This is a randomized, double-blind, placebo-controlled, single-center, three-part study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single and multiple ascending doses of GDC-0334 and the effect of food on the pharmacokinetics of GDC-0334 in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- GDC-0334, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0334Drug
Part 1: GDC-0334 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Parts 2 and 3: doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration in Part 3 is planned to be at least 14 days, but no longer than 28 days.
PlaceboDrug
Participants will receive GDC-0334-matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: GDC-0334 | Experimental | Participants in up to 7 cohorts will receive single, ascending doses of GDC-0334 under fasting conditions. Receives: Drug: GDC-0334 |
| Part 1: Placebo | Placebo comparator | Participants in up to 7 cohorts will receive single doses of placebo under fasting conditions. Receives: Drug: Placebo |
| Part 2: GDC-0334 | Experimental | Participants in up to 3 cohorts will receive single doses of GDC-0334 under fasting or fed conditions. Receives: Drug: GDC-0334 |
| Part 2: Placebo | Placebo comparator | Participants in up to 3 cohorts will receive single doses of placebo under fasting or fed conditions. Receives: Drug: Placebo |
| Part 3: GDC-0334 | Experimental | Participants in up to 4 cohorts will receive multiple, ascending doses of GDC-0334 under fasting or fed conditions. Receives: Drug: GDC-0334 |
| Part 3: Placebo | Placebo comparator | Participants in up to 4 cohorts will receive multiple doses of placebo under fasting or fed conditions. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events
Measured: From signing of informed consent until 30 days after the last dose of study drug (Up to approximately 42 days)
Severity of Adverse Events, as Graded per the World Health Organization (WHO) Toxicity Grading Scale
Measured: From signing of informed consent until 30 days after the last dose of study drug (Up to approximately 42 days)
Change from Baseline in Blood Pressure
Measured: Up to approximately 42 days
Change from Baseline in Heart Rate
Measured: Up to approximately 42 days
Incidence of Electrocardiogram (ECG) Abnormalities
Measured: Up to approximately 42 days
Incidence of Clinical Laboratory Abnormalities
Measured: Up to approximately 30 days
Incidence of Physical Examination Abnormalities
Measured: Up to approximately 42 days
Incidence of Neurological Examination Abnormalities
Measured: Up to approximately 31 days
Columbia-Suicide Severity Rating Scale (C-SSRS) - Part 3 Only
Measured: Up to approximately 42 days
Secondary outcomes (9)
Elapsed Time from Dosing at Which GDC-0334 is First Quantifiable in a Concentration versus Time profile (Tlag )
Measured: Up to approximately 35 days
Time to Maximum Plasma Concentration (Tmax) for GDC-0334
Measured: Up to approximately 35 days
Maximum Observed Plasma Concentration (Cmax) for GDC-0334
Measured: Up to approximately 35 days
Concentration at 24 hours Post-dose (C24) for GDC-0334
Measured: Up to approximately 35 days
Concentration at 12 hours Post-dose (C12) for GDC-0334
Measured: Up to approximately 35 days
Area Under the Plasma Concentration Curve from Time Zero to the Last Measurable Concentration (AUC0-t) for GDC-0334
Measured: Up to approximately 35 days
Area Under the Plasma Concentration Curve from Time Zero Extrapolated to Infinity (AUC0-inf) for GDC-0334
Measured: Up to approximately 35 days
Percentage of AUC0-inf Accounted for by Extrapolation to Infinity (AUC%extrap) for GDC-0334
Measured: Up to approximately 35 days
Apparent Terminal Elimination Half-Life (t1/2) for GDC-0334
Measured: Up to approximately 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start8 Dec 2017
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
Why it stopped: Molecule development was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381144
- Sponsor's protocol ID
- GB40223
- Other IDs
- 2017-003498-33, 2017
- Status last verified
- Oct 2019
- First submitted
- 18 Dec 2017
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-Blind, Placebo-Controlled, Single Centre, 3-Part, Study Designed to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Multiple Ascending Doses of GDC-0334 and the Effect of Food on the Pharmacokinetics of GDC-0334 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03381144
- Acronym / sponsor ID
- GB40223
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Molecule development was terminated
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, single-center, three-part study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single and multiple ascending doses of GDC-0334 and the effect of food on the pharmacokinetics of GDC-0334 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: GDC-0334 | Experimental | Drug: GDC-0334Participants in up to 7 cohorts will receive single, ascending doses of GDC-0334 under fasting conditions. |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboParticipants in up to 7 cohorts will receive single doses of placebo under fasting conditions. |
| Part 2: GDC-0334 | Experimental | Drug: GDC-0334Participants in up to 3 cohorts will receive single doses of GDC-0334 under fasting or fed conditions. |
| Part 2: Placebo | Placebo comparator | Drug: PlaceboParticipants in up to 3 cohorts will receive single doses of placebo under fasting or fed conditions. |
| Part 3: GDC-0334 | Experimental | Drug: GDC-0334Participants in up to 4 cohorts will receive multiple, ascending doses of GDC-0334 under fasting or fed conditions. |
| Part 3: Placebo | Placebo comparator | Drug: PlaceboParticipants in up to 4 cohorts will receive multiple doses of placebo under fasting or fed conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males or non-pregnant, non-lactating healthy females. Females may be of non-childbearing potential or childbearing potential. Healthy females of childbearing potential must agree to use a highly effective method of contraception.
- Healthy males must agree to use an adequate method of contraception
- Body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m^2) or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study
Key exclusion criteria (27 listed)
- Participants who have received any investigational medicinal product in a clinical research study within the previous 3 months
- Participants who are study site employees, or immediate family members of a study site or sponsor employee
- Participants who have previously been enrolled in this study. Participants who have enrolled in Part 1 are not permitted to enrol in Parts 2 or 3, and participants who have enrolled in Part 2 are not permitted to enroll in Part 3
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >14 units per week (1 unit = ½ pint beer, 25 milliliters (mL) of 40% spirit or a 125-mL glass of wine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDC-0334Part 1: GDC-0334 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Parts 2 and 3: doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration in Part 3 is planned to be at least 14 days, but no longer than 28 days. | Drug | Part 1: GDC-0334, Part 2: GDC-0334, Part 3: GDC-0334 |
| PlaceboParticipants will receive GDC-0334-matching placebo. | Drug | Part 1: Placebo, Part 2: Placebo, Part 3: Placebo |
Primary outcome
Percentage of Participants with Adverse Events
Time frame: From signing of informed consent until 30 days after the last dose of study drug (Up to approximately 42 days)
Severity of Adverse Events, as Graded per the World Health Organization (WHO) Toxicity Grading Scale
Time frame: From signing of informed consent until 30 days after the last dose of study drug (Up to approximately 42 days)
Change from Baseline in Blood Pressure
Time frame: Up to approximately 42 days
Change from Baseline in Heart Rate
Time frame: Up to approximately 42 days
Incidence of Electrocardiogram (ECG) Abnormalities
Time frame: Up to approximately 42 days
Incidence of Clinical Laboratory Abnormalities
Time frame: Up to approximately 30 days
Incidence of Physical Examination Abnormalities
Time frame: Up to approximately 42 days
Incidence of Neurological Examination Abnormalities
Time frame: Up to approximately 31 days
Columbia-Suicide Severity Rating Scale (C-SSRS) - Part 3 Only
Time frame: Up to approximately 42 days
9 secondary outcomes
Elapsed Time from Dosing at Which GDC-0334 is First Quantifiable in a Concentration versus Time profile (Tlag )
Time frame: Up to approximately 35 days
Time to Maximum Plasma Concentration (Tmax) for GDC-0334
Time frame: Up to approximately 35 days
Maximum Observed Plasma Concentration (Cmax) for GDC-0334
Time frame: Up to approximately 35 days
Concentration at 24 hours Post-dose (C24) for GDC-0334
Time frame: Up to approximately 35 days
Concentration at 12 hours Post-dose (C12) for GDC-0334
Time frame: Up to approximately 35 days
Area Under the Plasma Concentration Curve from Time Zero to the Last Measurable Concentration (AUC0-t) for GDC-0334
Time frame: Up to approximately 35 days
Area Under the Plasma Concentration Curve from Time Zero Extrapolated to Infinity (AUC0-inf) for GDC-0334
Time frame: Up to approximately 35 days
Percentage of AUC0-inf Accounted for by Extrapolation to Infinity (AUC%extrap) for GDC-0334
Time frame: Up to approximately 35 days
Apparent Terminal Elimination Half-Life (t1/2) for GDC-0334
Time frame: Up to approximately 35 days
Results and safety
The study was stopped early (reason given: Molecule development was terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-0334 in people with Healthy Volunteers, run by Genentech, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Molecule development was terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (time frame: From signing of informed consent until 30 days after the last dose of study drug (Up to approximately 42 days)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.