Healthy VolunteerPhase 1NCT02471859
A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants
A Phase 1 study testing GDC-3280 in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in United Kingdom.
Trial summary
This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- GDC-3280
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Dec 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is male or female, using highly effective contraception
- Has a body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive
- Is in good general health
- Having signed informed consent, is willing and able to comply with requirements of the study
Who cannot join
- Does not satisfy all screening criteria per protocol
- Is employed by or related to any personnel involved in the trial
- Has any history or condition that per protocol or in the opinion of the investigator could compromise the participant's safety or analysis of results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects
This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.
- Conditions
- Healthy Volunteer
- Being tested
- GDC-3280, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-3280Drug
GDC-3280 at various doses, depending on the cohort and treatment period
PlaceboDrug
Placebo at various doses, depending on the cohort and treatment period
| Study group | Role | What they receive |
|---|---|---|
| Part A: GDC-3280 | Experimental | Participants in multiple cohorts and treatment periods will receive single doses of GDC-3280 under fed/fasting conditions. Receives: Drug: GDC-3280 |
| Part A: Placebo | Placebo comparator | Participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions. Receives: Drug: Placebo |
| Part B: GCD-3280 | Experimental | Participants in different cohorts will receive GDC-3280 in multiple ascending doses under fed/fasting conditions.\n Receives: Drug: GDC-3280 |
| Part B: Placebo | Placebo comparator | Participants in different cohorts will receive placebo in multiple ascending doses under fed/fasting conditions.\n Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing an adverse event
Measured: Up to approximately 6 months
Secondary outcomes (6)
Maximum concentration (Cmax) for GDC-3280
Measured: Up to 4 days
Time to Cmax (Tmax) for GDC-3280
Measured: Up to 4 days
Total serum clearance for GDC-3280
Measured: Up to 4 days
Volume of distribution for GDC-3280
Measured: Up to 4 days
Elimination half-life for GDC-3280
Measured: Up to 4 days
Serum GDC-3280 concentration-time data by dosing group
Measured: Up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471859
- Sponsor's protocol ID
- GB29751
- Other IDs
- 2015-000560-33, 2015
- Status last verified
- Mar 2016
- First submitted
- 11 Jun 2015
- Last updated
- 17 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02471859
- Acronym / sponsor ID
- GB29751
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jun 2015 (estimated)
- 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 Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: GDC-3280 | Experimental | Drug: GDC-3280Participants in multiple cohorts and treatment periods will receive single doses of GDC-3280 under fed/fasting conditions. |
| Part A: Placebo | Placebo comparator | Drug: PlaceboParticipants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions. |
| Part B: GCD-3280 | Experimental | Drug: GDC-3280Participants in different cohorts will receive GDC-3280 in multiple ascending doses under fed/fasting conditions.\n |
| Part B: Placebo | Placebo comparator | Drug: PlaceboParticipants in different cohorts will receive placebo in multiple ascending doses under fed/fasting conditions.\n |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is male or female, using highly effective contraception
- Has a body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive
- Is in good general health
- Having signed informed consent, is willing and able to comply with requirements of the study
Key exclusion criteria (3 listed)
- Does not satisfy all screening criteria per protocol
- Is employed by or related to any personnel involved in the trial
- Has any history or condition that per protocol or in the opinion of the investigator could compromise the participant's safety or analysis of results
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-3280GDC-3280 at various doses, depending on the cohort and treatment period | Drug | Part A: GDC-3280, Part B: GCD-3280 |
| PlaceboPlacebo at various doses, depending on the cohort and treatment period | Drug | Part A: Placebo, Part B: Placebo |
Primary outcome
Number of participants experiencing an adverse event
Time frame: Up to approximately 6 months
6 secondary outcomes
Maximum concentration (Cmax) for GDC-3280
Time frame: Up to 4 days
Time to Cmax (Tmax) for GDC-3280
Time frame: Up to 4 days
Total serum clearance for GDC-3280
Time frame: Up to 4 days
Volume of distribution for GDC-3280
Time frame: Up to 4 days
Elimination half-life for GDC-3280
Time frame: Up to 4 days
Serum GDC-3280 concentration-time data by dosing group
Time frame: Up to 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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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
Hoffmann-La Roche
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-3280 in people with Healthy Volunteer, 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 3 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: finished, as of the sponsor's last update on 17 Mar 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants experiencing an adverse event (time frame: Up to approximately 6 months). 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 17 Mar 2016.