Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage (NCT NCT02300025)
NCT ID: NCT02300025
Last Updated: 2016-02-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
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
Results posted on
2016-02-19
Participant Flow
Participant milestones
| Measure |
Cohort 1: Normal Hepatic Function
Participants with normal hepatic function received single oral dose of 10 milligrams (mg) cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 2: Mild Hepatic Impairment
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 3: Moderate Hepatic Impairment
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 4: Severe Hepatic Impairment
Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
10
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage
Baseline characteristics by cohort
| Measure |
Cohort 1: Normal Hepatic Function
n=10 Participants
Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 2: Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 3: Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 4: Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment (Child-Pugh Class c, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56 Years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
59 Years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
61 Years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
53 Years
STANDARD_DEVIATION 5.3 • n=4 Participants
|
57 Years
STANDARD_DEVIATION 5.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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-dosePopulation: Pharmacokinetic (PK) population included all participants who received at least one dose of cobimetinib and had evaluable PK data.
Outcome measures
| Measure |
Cohort 2: Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 3: Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 4: Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 1: Normal Hepatic Function
n=10 Participants
Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
9.00 nanograms per milliliter (ng/mL)
Standard Deviation 4.09
|
8.03 nanograms per milliliter (ng/mL)
Standard Deviation 2.49
|
3.97 nanograms per milliliter (ng/mL)
Standard Deviation 1.77
|
10.7 nanograms per milliliter (ng/mL)
Standard Deviation 7.41
|
PRIMARY outcome
Timeframe: 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-dosePopulation: PK population.
Outcome measures
| Measure |
Cohort 2: Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 3: Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 4: Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 1: Normal Hepatic Function
n=10 Participants
Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
6 hrs
Interval 2.0 to 6.0
|
4 hrs
Interval 2.0 to 6.0
|
2 hrs
Interval 1.0 to 4.0
|
2 hrs
Interval 1.0 to 6.0
|
PRIMARY outcome
Timeframe: 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-dosePopulation: PK Population.
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).
Outcome measures
| Measure |
Cohort 2: Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 3: Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 4: Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 1: Normal Hepatic Function
n=10 Participants
Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
|
498 ng*hr/mL
Standard Deviation 200
|
539 ng*hr/mL
Standard Deviation 296
|
268 ng*hr/mL
Standard Deviation 181
|
604 ng*hr/mL
Standard Deviation 606
|
PRIMARY outcome
Timeframe: 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-dosePopulation: PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
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- ∞).
Outcome measures
| Measure |
Cohort 2: Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 3: Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 4: Severe Hepatic Impairment
n=5 Participants
Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 1: Normal Hepatic Function
n=10 Participants
Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
|
530 ng*hr/mL
Standard Deviation 206
|
579 ng*hr/mL
Standard Deviation 301
|
370 ng*hr/mL
Standard Deviation 163
|
637 ng*hr/mL
Standard Deviation 606
|
PRIMARY outcome
Timeframe: 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-dosePopulation: PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
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.
Outcome measures
| Measure |
Cohort 2: Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 3: Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 4: Severe Hepatic Impairment
n=5 Participants
Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 1: Normal Hepatic Function
n=10 Participants
Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
|---|---|---|---|---|
|
Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)
|
6.69 % extrapolated
Standard Deviation 2.63
|
8.17 % extrapolated
Standard Deviation 4.36
|
15.90 % extrapolated
Standard Deviation 4.79
|
7.37 % extrapolated
Standard Deviation 4.37
|
PRIMARY outcome
Timeframe: 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-dosePopulation: PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
λZ was defined as the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase.
Outcome measures
| Measure |
Cohort 2: Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 3: Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 4: Severe Hepatic Impairment
n=5 Participants
Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 1: Normal Hepatic Function
n=10 Participants
Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
|---|---|---|---|---|
|
Apparent Terminal Elimination Rate Constant (λZ)
|
0.00852 1 per hr (1/hr)
Standard Deviation 0.00315
|
0.00702 1 per hr (1/hr)
Standard Deviation 0.00181
|
0.00509 1 per hr (1/hr)
Standard Deviation 0.00114
|
0.00942 1 per hr (1/hr)
Standard Deviation 0.00259
|
PRIMARY outcome
Timeframe: 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-dosePopulation: PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
Plasma decay half-life is the time measured for the plasma concentration of cobimetinib to decrease by one half.
Outcome measures
| Measure |
Cohort 2: Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 3: Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 4: Severe Hepatic Impairment
n=5 Participants
Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 1: Normal Hepatic Function
n=10 Participants
Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
|---|---|---|---|---|
|
Plasma Decay Half-Life (t1/2)
|
95.2 hr
Standard Deviation 48.2
|
104.0 hr
Standard Deviation 24.4
|
143.0 hr
Standard Deviation 40.4
|
79.1 hr
Standard Deviation 22.7
|
PRIMARY outcome
Timeframe: 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-dosePopulation: PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
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.
Outcome measures
| Measure |
Cohort 2: Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 3: Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 4: Severe Hepatic Impairment
n=5 Participants
Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 1: Normal Hepatic Function
n=10 Participants
Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F)
|
22.9 Liter per hr (L/hr)
Standard Deviation 13.2
|
21.9 Liter per hr (L/hr)
Standard Deviation 11.7
|
31.7 Liter per hr (L/hr)
Standard Deviation 14.5
|
23.4 Liter per hr (L/hr)
Standard Deviation 11.6
|
PRIMARY outcome
Timeframe: 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-dosePopulation: PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
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.
Outcome measures
| Measure |
Cohort 2: Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 3: Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 4: Severe Hepatic Impairment
n=5 Participants
Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 1: Normal Hepatic Function
n=10 Participants
Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
2880 Liter
Standard Deviation 1370
|
3230 Liter
Standard Deviation 1650
|
6280 Liter
Standard Deviation 2480
|
2580 Liter
Standard Deviation 1300
|
Adverse Events
Cohort 1: Normal Hepatic Function
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Mild Hepatic Impairment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3: Moderate Hepatic Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4: Severe Hepatic Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Normal Hepatic Function
n=10 participants at risk
Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 2: Mild Hepatic Impairment
n=6 participants at risk
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 3: Moderate Hepatic Impairment
n=6 participants at risk
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
Cohort 4: Severe Hepatic Impairment
n=6 participants at risk
Participants with severe hepatic impairment (Child-Pugh Class A, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Haematochezia
|
10.0%
1/10 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
16.7%
1/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
16.7%
1/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
16.7%
1/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
16.7%
1/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
16.7%
1/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
|
Metabolism and nutrition disorders
Gout
|
10.0%
1/10 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
16.7%
1/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
16.7%
1/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to approximately 2 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER