Healthy VolunteerPhase 1NCT02136524
A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation
A Phase 1 study testing cobimetinib in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in United States.
Trial summary
This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence crossover study to determine the relative bioavailability of cobimetinib administered as a single dose of the tablet formulation relative to a single dose of the capsule formulation to healthy male and female 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 Volunteer
- What is being tested?
- cobimetinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2014
- 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 male and female volunteers between 18 and 55 years of age, inclusive
- Body mass index between 18.5 to 32.0 kg/m2, inclusive;
- Adequate renal, liver, and hematologic function
- Participants who are in good health as determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE, RANDOMIZED, 2-PERIOD, 2-TREATMENT SEQUENCE CROSS-OVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY OF COBIMETINIB ADMINISTERED AS A TABLET FORMULATION COMPARED TO A CAPSULE FORMULATION IN HEALTHY SUBJECTS
This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence crossover study to determine the relative bioavailability of cobimetinib administered as a single dose of the tablet formulation relative to a single dose of the capsule formulation to healthy male and female participants. A minimum of 24 participants (12 participants per sequence) will complete the study. Participants will be randomly assigned to 2 possible sequences (i.e., I: A/B, II: B/A) where the treatments are as follows: Treatment A: One cobimetinib tablet administered as a single oral dose after at least an 8-hour fast; Treatment B: Four cobimetinib capsules administered as a single oral dose after at least an 8-hour fast. The study is expected to last approximately 7 weeks.
- Conditions
- Healthy Volunteer
- Being tested
- cobimetinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cobimetinibDrug
Also called GDC-0973, XL-518
Single, oral dose given as a tablet on Day 1 after a minimum 8 h fast
cobimetinibDrug
Also called GDC-0973, XL-518
Single, oral dose given as 4 capsules on Day 1 after a minimum 8 h fast
| Study group | Role | What they receive |
|---|---|---|
| Capsule formulation | Experimental | Not described Receives: Drug: cobimetinib |
| Tablet formulation | Experimental | Not described Receives: Drug: cobimetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Time to maximum concentration (tmax)
Measured: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Area under the concentration-time curve (AUC)
Measured: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Apparent terminal elimination rate constant
Measured: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Half-life (t1/2)
Measured: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Apparent clearance (CL/F)
Measured: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Apparent volume of distribution (Vz/F)
Measured: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Relative bioavailability (Frel)
Measured: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Secondary outcomes (1)
Incidence of adverse events
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionMay 2014
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT02136524
- Sponsor's protocol ID
- GP28370
- Status last verified
- Nov 2016
- First submitted
- 9 May 2014
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, SINGLE-DOSE, RANDOMIZED, 2-PERIOD, 2-TREATMENT SEQUENCE CROSS-OVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY OF COBIMETINIB ADMINISTERED AS A TABLET FORMULATION COMPARED TO A CAPSULE FORMULATION IN HEALTHY SUBJECTS
- ClinicalTrials.gov ID
- NCT02136524
- Acronym / sponsor ID
- GP28370
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 May 2014 (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 study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence crossover study to determine the relative bioavailability of cobimetinib administered as a single dose of the tablet formulation relative to a single dose of the capsule formulation to healthy male and female participants. A minimum of 24 participants (12 participants per sequence) will complete the study. Participants will be randomly assigned to 2 possible sequences (i.e., I: A/B, II: B/A) where the treatments are as follows: Treatment A: One cobimetinib tablet administered as a single oral dose after at least an 8-hour fast; Treatment B: Four cobimetinib capsules administered as a single oral dose after at least an 8-hour fast. The study is expected to last approximately 7 weeks.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsule formulation | Experimental | Drug: cobimetinib |
| Tablet formulation | Experimental | Drug: cobimetinib |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female volunteers between 18 and 55 years of age, inclusive
- Body mass index between 18.5 to 32.0 kg/m2, inclusive;
- Adequate renal, liver, and hematologic function
- Participants who are in good health as determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations
Key exclusion criteria (1 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator)
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 |
|---|---|---|
| cobimetinibAlso: GDC-0973, XL-518Single, oral dose given as a tablet on Day 1 after a minimum 8 h fast | Drug | Tablet formulation |
| cobimetinibAlso: GDC-0973, XL-518Single, oral dose given as 4 capsules on Day 1 after a minimum 8 h fast | Drug | Capsule formulation |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Time to maximum concentration (tmax)
Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Area under the concentration-time curve (AUC)
Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Apparent terminal elimination rate constant
Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Half-life (t1/2)
Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Apparent clearance (CL/F)
Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Apparent volume of distribution (Vz/F)
Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Relative bioavailability (Frel)
Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
1 secondary outcome
Incidence of adverse events
Time frame: Up to 4 weeks
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 2 Nov 2016.
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Healthy Participants
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 cobimetinib in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in United States.
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 1 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 2 Nov 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 States. 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. 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?
Maximum observed concentration (Cmax) (time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)). The study lists 8 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 2 Nov 2016.