Trial Outcomes & Findings for A Study of Relative Bioavailability and Food Effect Study of Cobimetinib in Healthy Participants (NCT NCT01249131)
NCT ID: NCT01249131
Last Updated: 2017-08-15
Results Overview
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
Results posted on
2017-08-15
Participant Flow
Participant milestones
| Measure |
Treatment A First, Then Treatment B, Followed by Treatment C
Treatment A: One 20-milligram (mg) tablet of cobimetinib administered orally with 240 milliliter (mL) room temperature water after at least an 8-hour fast, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard Food and Drug Administration (FDA) high-fat meal, in third intervention period. The washout period between each period was a minimum of 10 days.
|
Treatment A First, Then Treatment C, Followed by Treatment B
Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
|
Treatment B First, Then Treatment A, Followed by Treatment C
Treatment B first, then Treatment A, followed by Treatment C Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in third intervention period.
|
Treatment B First, Then Treatment C, Followed by Treatment A
Treatment B first, then Treatment C, followed by Treatment A Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
|
Treatment C First, Then Treatment A, Followed by Treatment B
Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
|
Treatment C First, Then Treatment B, Followed by Treatment A
Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
|
|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
3
|
3
|
4
|
3
|
3
|
4
|
|
First Intervention
COMPLETED
|
3
|
3
|
4
|
3
|
3
|
4
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period of 10 Days
STARTED
|
3
|
3
|
4
|
3
|
2
|
4
|
|
Washout Period of 10 Days
COMPLETED
|
3
|
3
|
4
|
3
|
2
|
4
|
|
Washout Period of 10 Days
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
3
|
3
|
4
|
3
|
2
|
4
|
|
Second Intervention
COMPLETED
|
3
|
3
|
4
|
3
|
2
|
4
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
3
|
3
|
4
|
3
|
2
|
4
|
|
Third Intervention
COMPLETED
|
3
|
3
|
4
|
3
|
2
|
4
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment A First, Then Treatment B, Followed by Treatment C
Treatment A: One 20-milligram (mg) tablet of cobimetinib administered orally with 240 milliliter (mL) room temperature water after at least an 8-hour fast, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard Food and Drug Administration (FDA) high-fat meal, in third intervention period. The washout period between each period was a minimum of 10 days.
|
Treatment A First, Then Treatment C, Followed by Treatment B
Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
|
Treatment B First, Then Treatment A, Followed by Treatment C
Treatment B first, then Treatment A, followed by Treatment C Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in third intervention period.
|
Treatment B First, Then Treatment C, Followed by Treatment A
Treatment B first, then Treatment C, followed by Treatment A Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
|
Treatment C First, Then Treatment A, Followed by Treatment B
Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
|
Treatment C First, Then Treatment B, Followed by Treatment A
Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
|
|---|---|---|---|---|---|---|
|
Washout Period of 10 Days
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Relative Bioavailability and Food Effect Study of Cobimetinib in Healthy Participants
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=20 Participants
All participants randomized to any treatment.
|
|---|---|
|
Age, Continuous
|
36 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdosePopulation: Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
Outcome measures
| Measure |
Cobimetinib One 20 mg Tablet [Fasted]
n=19 Participants
One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
|
Cobimetinib Four 5 mg Capsules [Fasted]
n=18 Participants
Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
|
Cobimetinib One 20 mg Tablet [Fed]
n=20 Participants
One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
|
|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
|
780 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34.7
|
717 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 45.1
|
858 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 42.4
|
PRIMARY outcome
Timeframe: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdosePopulation: Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.
Outcome measures
| Measure |
Cobimetinib One 20 mg Tablet [Fasted]
n=19 Participants
One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
|
Cobimetinib Four 5 mg Capsules [Fasted]
n=18 Participants
Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
|
Cobimetinib One 20 mg Tablet [Fed]
n=20 Participants
One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
16.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 33.5
|
14.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 45.9
|
17.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43.1
|
PRIMARY outcome
Timeframe: Day 1 at 0 hour (predose)Population: Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.
Outcome measures
| Measure |
Cobimetinib One 20 mg Tablet [Fasted]
n=5 Participants
One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
|
Cobimetinib Four 5 mg Capsules [Fasted]
n=7 Participants
Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
|
Cobimetinib One 20 mg Tablet [Fed]
n=5 Participants
One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
|
|---|---|---|---|
|
Minimum Observed Plasma Concentration (Cmin)
|
0.307 ng/mL
Geometric Coefficient of Variation 46.6
|
0.36 ng/mL
Geometric Coefficient of Variation 56.6
|
0.361 ng/mL
Geometric Coefficient of Variation 60.3
|
PRIMARY outcome
Timeframe: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdosePopulation: Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = 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. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Cobimetinib One 20 mg Tablet [Fasted]
n=19 Participants
One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
|
Cobimetinib Four 5 mg Capsules [Fasted]
n=18 Participants
Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
|
Cobimetinib One 20 mg Tablet [Fed]
n=20 Participants
One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
|
|---|---|---|---|
|
Apparent Oral Clearance (CL/F)
|
25.6 Liters per hour (L/hr)
Geometric Coefficient of Variation 34.7
|
25.2 Liters per hour (L/hr)
Geometric Coefficient of Variation 45.1
|
23.3 Liters per hour (L/hr)
Geometric Coefficient of Variation 42.4
|
PRIMARY outcome
Timeframe: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdosePopulation: Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.
Volume of distribution is 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. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Cobimetinib One 20 mg Tablet [Fasted]
n=19 Participants
One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
|
Cobimetinib Four 5 mg Capsules [Fasted]
n=18 Participants
Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
|
Cobimetinib One 20 mg Tablet [Fed]
n=20 Participants
One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
|
|---|---|---|---|
|
Apparent Volume of Distribution (V/F)
|
2103 Liters (L)
Geometric Coefficient of Variation 40.4
|
1930 Liters (L)
Geometric Coefficient of Variation 50.2
|
1900 Liters (L)
Geometric Coefficient of Variation 38.3
|
Adverse Events
Cobimetinib One 20 mg Tablet [Fasted]
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cobimetinib Four 5 mg Capsules [Fasted]
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cobimetinib One 20 mg Tablet [Fed]
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cobimetinib One 20 mg Tablet [Fasted]
n=19 participants at risk
One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
|
Cobimetinib Four 5 mg Capsules [Fasted]
n=19 participants at risk
Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
|
Cobimetinib One 20 mg Tablet [Fed]
n=20 participants at risk
One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
10.5%
2/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
10.5%
2/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
10.0%
2/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
10.5%
2/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Eye disorders
Photophobia
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Eye disorders
Vision blurred
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Eye disorders
Visual impairment
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
General disorders
Chills
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
General disorders
Vessel puncture site haematoma
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
General disorders
Chest pain
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
General disorders
Feeling hot
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
General disorders
Vessel puncture site pain
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
10.5%
2/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Nervous system disorders
Headache
|
10.5%
2/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
10.5%
2/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
10.0%
2/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Infections and infestations
Viral infection
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Injury, poisoning and procedural complications
Scratch
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
5.0%
1/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
|
Vascular disorders
Flushing
|
5.3%
1/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/19 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
0.00%
0/20 • Adverse events were recorded from start of study treatment in first period to end of last period (up to 30 days)
One participant discontinued study in first period and did not receive Cobimetinib One 20 mg Tablet \[Fasted\] in second period and Cobimetinib Four 5 mg Capsules \[Fasted\] in third period. Therefore, only 19 participants were evaluable for adverse events in these treatment arms.
|
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