Healthy VolunteerPhase 1NCT02300025

A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage

A Phase 1 study testing cobimetinib in people with Healthy Volunteer, run by Genentech, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 74 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: 3 sitesUnited States
Study dates: Aug 2014to Jan 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 74 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female subjects between 18 and 74 years of age, inclusive
Body weight >/=45 kg and body mass index between 17 and 41 kg/m2, inclusive
Subjects with hepatic impairment must have a Child-Pugh score of 5 to 6 (mild), 7 to 9 (moderate), or 10 to 15 (severe) and have stable hepatic insufficiency within 1 month prior to Screening and a stable medication regimen for at least 1 month prior to Check-in
Agreement to use highly effective contraceptive methods as defined in the protocol

Who cannot join

Significant illness, including infections, or hospitalization within the 2 weeks prior to dosing, except for subjects with hepatic impairment who due to their liver disease may be affected by significant medical problems which require frequent hospitalizations. Invasive systemic fungal infections need to be fully treated prior to study entry
Significant history or clinical manifestations of any cardiac event that would put the subject at risk in the opinion of the Investigator
Use of drugs of abuse within 1 month of Screening or during the entire study
Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Study site
Anaheim, California, 92801
Study site
Miami, Florida, 330014
Study site
Orlando, Florida, 32809

Other trials in United States

About this study

This study is an open-label, multi-center, single-dose, parallel group study to determine the pharmacokinetics, safety, and tolerability of cobimetinib administered at 10 mg to fasted male and female adult subjects with varying degrees of hepatic function. The study will be conducted based on the Child-Pugh classification of hepatic impairment. The anticipated duration of the study is 7.5 weeks. The target sample sizes are: 18 volunteers with varying degrees of hepatic function and up to 12 healthy control volunteers.

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
single oral 10-mg dose of cobimetinib

Study groups in NCT02300025
Study group	Role	What they receive
Cohort 1: Normal function	Experimental	Not described Receives: Drug: cobimetinib
Cohort 2: Mild Hepatic Impairment	Experimental	Not described Receives: Drug: cobimetinib
Cohort 3: Moderate Hepatic Impairment	Experimental	Not described Receives: Drug: cobimetinib
Cohort 4: Severe Hepatic Impairment	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 Plasma Concentration (Cmax)
Measured: Pre-dose (0 hours [hrs]), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
AUC (0-t) was defined as area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).
Measured: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
AUC (0 - ∞) was defined as AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t- ∞).
Measured: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)
AUC% extrapolated was defined as the percentage of AUC [0-∞] obtained by forward extrapolation. It is calculated as [AUC (0-∞) minus AUC(0-t]*100/ AUC (0-∞), where AUC [0-∞] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-t) is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.
Measured: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Apparent Terminal Elimination Rate Constant (λZ)
λZ was defined as the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase.
Measured: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration of cobimetinib to decrease by one half.
Measured: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Apparent Volume of Distribution (Vz/F)
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F after the oral dose is influenced by the fraction absorbed.
Measured: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Jan 2015

First posted24 Nov 2014 (estimated)
Study startAug 2014
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02300025
Sponsor's protocol ID: GP29342
Status last verified: Jan 2016
First submitted: 20 Nov 2014
Last updated: 19 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage
ClinicalTrials.gov ID: NCT02300025
Acronym / sponsor ID: GP29342
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: Aug 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 24 Nov 2014 (estimated)
Results: Posted 19 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cohort 1: Normal function	Experimental	Drug: cobimetinib
Cohort 2: Mild Hepatic Impairment	Experimental	Drug: cobimetinib
Cohort 3: Moderate Hepatic Impairment	Experimental	Drug: cobimetinib
Cohort 4: Severe Hepatic Impairment	Experimental	Drug: cobimetinib

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male and female subjects between 18 and 74 years of age, inclusive
Body weight >/=45 kg and body mass index between 17 and 41 kg/m2, inclusive
Subjects with hepatic impairment must have a Child-Pugh score of 5 to 6 (mild), 7 to 9 (moderate), or 10 to 15 (severe) and have stable hepatic insufficiency within 1 month prior to Screening and a stable medication regimen for at least 1 month prior to Check-in
Agreement to use highly effective contraceptive methods as defined in the protocol

Key exclusion criteria (4 listed)

Significant illness, including infections, or hospitalization within the 2 weeks prior to dosing, except for subjects with hepatic impairment who due to their liver disease may be affected by significant medical problems which require frequent hospitalizations. Invasive systemic fungal infections need to be fully treated prior to study entry
Significant history or clinical manifestations of any cardiac event that would put the subject at risk in the opinion of the Investigator
Use of drugs of abuse within 1 month of Screening or during the entire study
Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study

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
cobimetinibsingle oral 10-mg dose of cobimetinib	Drug	Cohort 1: Normal function, Cohort 2: Mild Hepatic Impairment, Cohort 3: Moderate Hepatic Impairment, Cohort 4: Severe Hepatic Impairment

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose (0 hours [hrs]), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time frame: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
AUC (0-t) was defined as area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time frame: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
AUC (0 - ∞) was defined as AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t- ∞).
Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)
Time frame: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
AUC% extrapolated was defined as the percentage of AUC [0-∞] obtained by forward extrapolation. It is calculated as [AUC (0-∞) minus AUC(0-t]*100/ AUC (0-∞), where AUC [0-∞] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-t) is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.
Apparent Terminal Elimination Rate Constant (λZ)
Time frame: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
λZ was defined as the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase.
Plasma Decay Half-Life (t1/2)
Time frame: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Plasma decay half-life is the time measured for the plasma concentration of cobimetinib to decrease by one half.
Apparent Oral Clearance (CL/F)
Time frame: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Apparent Volume of Distribution (Vz/F)
Time frame: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F after the oral dose is influenced by the fraction absorbed.

Results and safety

Results posted to the registry on 19 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Normal Hepatic Function	10	10
Cohort 2: Mild Hepatic Impairment	6	6
Cohort 3: Moderate Hepatic Impairment	6	6
Cohort 4: Severe Hepatic Impairment	6	6

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: Pre-dose (0 hours [hrs]), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose. Mean (Standard Deviation). Unit: nanograms per milliliter (ng/mL)

Measure	Cohort 1: Normal Hepatic Function n = 10	Cohort 2: Mild Hepatic Impairment n = 6	Cohort 3: Moderate Hepatic Impairment n = 6	Cohort 4: Severe Hepatic Impairment n = 6
Value	10.7 (7.41)	9.00 (4.09)	8.03 (2.49)	3.97 (1.77)

Cohort 1: Normal Hepatic Function vs Cohort 2: Mild Hepatic Impairment: LS means ratio: 92.2 (90% CI 59.2 to 143.4)
Cohort 1: Normal Hepatic Function vs Cohort 3: Moderate Hepatic Impairment: LS means ratio: 84.9 (90% CI 54.6 to 132.1)
Cohort 1: Normal Hepatic Function vs Cohort 4: Severe Hepatic Impairment: LS means ratio: 39.0 (90% CI 25.1 to 60.7)

Population analysed: Pharmacokinetic (PK) population included all participants who received at least one dose of cobimetinib and had evaluable PK data.

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose. Median (Full Range). Unit: hrs

Measure	Cohort 1: Normal Hepatic Function n = 10	Cohort 2: Mild Hepatic Impairment n = 6	Cohort 3: Moderate Hepatic Impairment n = 6	Cohort 4: Severe Hepatic Impairment n = 6
Value	2 (1 to 6)	6 (2 to 6)	4 (2 to 6)	2 (1 to 4)

Population analysed: PK population.

Primary outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

Time frame: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Cohort 1: Normal Hepatic Function n = 10	Cohort 2: Mild Hepatic Impairment n = 6	Cohort 3: Moderate Hepatic Impairment n = 6	Cohort 4: Severe Hepatic Impairment n = 6
Value	604 (606)	498 (200)	539 (296)	268 (181)

Cohort 1: Normal Hepatic Function vs Cohort 2: Mild Hepatic Impairment: LS means ratio: 98.4 (90% CI 52.0 to 186.0)
Cohort 1: Normal Hepatic Function vs Cohort 3: Moderate Hepatic Impairment: LS means ratio: 102.2 (90% CI 54.0 to 193.2)
Cohort 1: Normal Hepatic Function vs Cohort 4: Severe Hepatic Impairment: LS means ratio: 42.5 (90% CI 22.5 to 80.5)

Population analysed: PK Population.

Primary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

Time frame: Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Cohort 1: Normal Hepatic Function n = 10	Cohort 2: Mild Hepatic Impairment n = 6	Cohort 3: Moderate Hepatic Impairment n = 6	Cohort 4: Severe Hepatic Impairment n = 5
Value	637 (606)	530 (206)	579 (301)	370 (163)

Cohort 1: Normal Hepatic Function vs Cohort 2: Mild Hepatic Impairment: LS means ratio: 97.6 (90% CI 59.3 to 160.6)
Cohort 1: Normal Hepatic Function vs Cohort 3: Moderate Hepatic Impairment: LS means ratio: 103.0 (90% CI 62.6 to 169.6)
Cohort 1: Normal Hepatic Function vs Cohort 4: Severe Hepatic Impairment: LS means ratio: 68.5 (90% CI 40.4 to 116.2)

Population analysed: PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.

Adverse events

Time frame: Up to 30 days after the last dose of study drug (up to approximately 2 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Normal Hepatic Function	0 of 10 (0%)	3 of 10 (30%)	Not reported
Cohort 2: Mild Hepatic Impairment	0 of 6 (0%)	3 of 6 (50%)	Not reported
Cohort 3: Moderate Hepatic Impairment	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Cohort 4: Severe Hepatic Impairment	0 of 6 (0%)	1 of 6 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

3 sites 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 3 sites 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 4 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 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 19 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Plasma Concentration (Cmax) (time frame: Pre-dose (0 hours [hrs]), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose). 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?

On the ClinicalTrials.gov record for NCT02300025.

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 19 Feb 2016.