Trial Outcomes & Findings for To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers (NCT NCT02056392)

NCT ID: NCT02056392

Last Updated: 2015-11-09

Results Overview

Change from baseline in QTcF at 30 minutes (msec)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 54 participants
• Primary outcome timeframe: 30 min
• Results posted on: 2015-11-09

Participant Flow

Participant milestones

Measure	Selumetinib/Moxifloxacin/Selumetinib Placebo	Moxifloxacin/Selumetinib/Selumetinib Placebo	Moxifloxacin/Selumetinib Placebo/Selumetinib	Selumetinib Placebo/Moxifloxacin/Selumetinib	Selumetinib Placebo/Selumetinib/Moxifloxacin	Selumetinib/Selumetinib Placebo/Moxifloxacin
Overall Study STARTED	10	9	9	9	8	9
Overall Study COMPLETED	8	8	6	9	7	9
Overall Study NOT COMPLETED	2	1	3	0	1	0

Reasons for withdrawal

Measure	Selumetinib/Moxifloxacin/Selumetinib Placebo	Moxifloxacin/Selumetinib/Selumetinib Placebo	Moxifloxacin/Selumetinib Placebo/Selumetinib	Selumetinib Placebo/Moxifloxacin/Selumetinib	Selumetinib Placebo/Selumetinib/Moxifloxacin	Selumetinib/Selumetinib Placebo/Moxifloxacin
Overall Study Lost to Follow-up	0	1	2	0	0	0
Overall Study Protocol Violation	1	0	1	0	0	0
Overall Study Withdrawal by Subject	1	0	0	0	1	0

Baseline Characteristics

To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers

Baseline characteristics by cohort

Measure	Selumetinib/Moxifloxacin/Selumetinib Placebo n=10 Participants	Moxifloxacin/Selumetinib/Selumetinib Placebo n=9 Participants	Moxifloxacin/Selumetinib Placebo/Selumetinib n=9 Participants	Selumetinib Placebo/Moxifloxacin/Selumetinib n=9 Participants	Selumetinib Placebo/Selumetinib/Moxifloxacin n=8 Participants	Selumetinib/Selumetinib Placebo/Moxifloxacin n=9 Participants	Total n=54 Participants Total of all reporting groups
Age, Continuous	26 Years STANDARD_DEVIATION 7 • n=5 Participants	25 Years STANDARD_DEVIATION 5 • n=7 Participants	25 Years STANDARD_DEVIATION 4 • n=5 Participants	31 Years STANDARD_DEVIATION 8 • n=4 Participants	28 Years STANDARD_DEVIATION 8 • n=21 Participants	30 Years STANDARD_DEVIATION 9 • n=10 Participants	27 Years STANDARD_DEVIATION 7 • n=115 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	8 Participants n=21 Participants	9 Participants n=10 Participants	54 Participants n=115 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	4 Participants n=10 Participants	29 Participants n=115 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=10 Participants	25 Participants n=115 Participants

PRIMARY outcome

Timeframe: 30 min

Population: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Change from baseline in QTcF at 30 minutes (msec)

Outcome measures

Measure	Moxifloxacin n=50 change from baseline Moxiflxacin 400 mg (open label)	Placebo n=49 change from baseline Selumetinib placebo (3 capsules)	Selumetinib n=50 change from baseline Selumetinib 75mg bs (3x25mg capsules)
Change From Baseline in QTcF	2.0 msec Interval 0.5 to 3.5	-4.1 msec Interval -5.6 to -2.5	-4.2 msec Interval -5.7 to -2.7

PRIMARY outcome

Timeframe: 1 hour

Population: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Change from baseline in QTcF at 1 hour (msec)

Outcome measures

Measure	Moxifloxacin n=50 change from baseline Moxiflxacin 400 mg (open label)	Placebo n=49 change from baseline Selumetinib placebo (3 capsules)	Selumetinib n=50 change from baseline Selumetinib 75mg bs (3x25mg capsules)
Change From Baseline in QTcF	7.9 msec Interval 6.4 to 9.4	-1.4 msec Interval -2.9 to 0.2	-1.7 msec Interval -3.2 to -0.2

PRIMARY outcome

Timeframe: 1 hour 30 min

Population: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Change from baseline in QTcF at 1 hour 30 min (msec)

Outcome measures

Measure	Moxifloxacin n=50 change from baseline Moxiflxacin 400 mg (open label)	Placebo n=49 change from baseline Selumetinib placebo (3 capsules)	Selumetinib n=50 change from baseline Selumetinib 75mg bs (3x25mg capsules)
Change From Baseline in QTcF	8.1 msec Interval 6.6 to 9.6	-1.8 msec Interval -3.3 to -0.2	-0.9 msec Interval -2.4 to 0.6

PRIMARY outcome

Timeframe: 2 hours

Population: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Change from baseline in QTcF at 2 hours (msec)

Outcome measures

Measure	Moxifloxacin n=50 change from baseline Moxiflxacin 400 mg (open label)	Placebo n=49 change from baseline Selumetinib placebo (3 capsules)	Selumetinib n=50 change from baseline Selumetinib 75mg bs (3x25mg capsules)
Change From Baseline in QTcF	7.9 msec Interval 6.4 to 9.4	-2.3 msec Interval -3.8 to -0.7	-1.9 msec Interval -3.4 to -0.4

PRIMARY outcome

Timeframe: 3 hours

Population: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Change from baseline in QTcF at 3 hours (msec)

Outcome measures

Measure	Moxifloxacin n=50 change from baseline Moxiflxacin 400 mg (open label)	Placebo n=49 change from baseline Selumetinib placebo (3 capsules)	Selumetinib n=50 change from baseline Selumetinib 75mg bs (3x25mg capsules)
Change From Baseline in QTcF	8.8 msec Interval 7.3 to 10.3	-3.2 msec Interval -4.7 to -1.6	-3.3 msec Interval -4.8 to -1.8

PRIMARY outcome

Timeframe: 4 hours

Population: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Change from baseline in QTcF at 4 hours (msec)

Outcome measures

Measure	Moxifloxacin n=50 change from baseline Moxiflxacin 400 mg (open label)	Placebo n=49 change from baseline Selumetinib placebo (3 capsules)	Selumetinib n=50 change from baseline Selumetinib 75mg bs (3x25mg capsules)
Change From Baseline in QTcF	8.6 msec Interval 7.1 to 10.1	-2.2 msec Interval -3.7 to -0.7	-3.7 msec Interval -5.2 to -2.2

PRIMARY outcome

Timeframe: 6 hours

Population: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Change from baseline in QTcF at 6 hours (msec)

Outcome measures

Measure	Moxifloxacin n=50 change from baseline Moxiflxacin 400 mg (open label)	Placebo n=49 change from baseline Selumetinib placebo (3 capsules)	Selumetinib n=50 change from baseline Selumetinib 75mg bs (3x25mg capsules)
Change From Baseline in QTcF	4.7 msec Interval 3.2 to 6.2	-4.1 msec Interval -5.6 to -2.6	-5.9 msec Interval -7.4 to -4.4

PRIMARY outcome

Timeframe: 8 hours

Population: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Change from baseline in QTcF at 8 hours (msec)

Outcome measures

Measure	Moxifloxacin n=50 change from baseline Moxiflxacin 400 mg (open label)	Placebo n=49 change from baseline Selumetinib placebo (3 capsules)	Selumetinib n=50 change from baseline Selumetinib 75mg bs (3x25mg capsules)
Change From Baseline in QTcF	3.6 msec Interval 2.1 to 5.1	-5.3 msec Interval -6.8 to -3.7	-6.5 msec Interval -8.0 to -5.0

PRIMARY outcome

Timeframe: 12 hours

Population: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Change from baseline in QTcF at 12 hours (msec)

Outcome measures

Measure	Moxifloxacin n=50 change from baseline Moxiflxacin 400 mg (open label)	Placebo n=49 change from baseline Selumetinib placebo (3 capsules)	Selumetinib n=50 change from baseline Selumetinib 75mg bs (3x25mg capsules)
Change From Baseline in QTcF	4.2 msec Interval 2.7 to 5.7	-3.4 msec Interval -5.0 to -1.9	-8.2 msec Interval -9.7 to -6.7

PRIMARY outcome

Timeframe: 24 hours

Population: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Change from baseline in QTcF at 24 hours (msec)

Outcome measures

Measure	Moxifloxacin n=50 change from baseline Moxiflxacin 400 mg (open label)	Placebo n=49 change from baseline Selumetinib placebo (3 capsules)	Selumetinib n=50 change from baseline Selumetinib 75mg bs (3x25mg capsules)
Change From Baseline in QTcF	2.4 msec Interval 0.9 to 3.9	-1.6 msec Interval -3.1 to -0.1	-4.1 msec Interval -5.6 to -2.6

Adverse Events

Selumetinib

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Moxifloxacin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Selumetinib n=51 participants at risk Selumetinib 75mg bs (3x25mg capsules)	Moxifloxacin n=51 participants at risk Moxiflxacin 400 mg (open label)	Placebo n=50 participants at risk Selumetinib placebo (3 capsules)
Gastrointestinal disorders Hemorrhoids	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	2.0% 1/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).

Other adverse events

Measure	Selumetinib n=51 participants at risk Selumetinib 75mg bs (3x25mg capsules)	Moxifloxacin n=51 participants at risk Moxiflxacin 400 mg (open label)	Placebo n=50 participants at risk Selumetinib placebo (3 capsules)
Nervous system disorders Headache	5.9% 3/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	2.0% 1/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).
Nervous system disorders Disturbance in attention	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	2.0% 1/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).
Gastrointestinal disorders Abdominal pain	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	2.0% 1/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).
Gastrointestinal disorders Dyspepsia	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	2.0% 1/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	2.0% 1/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).
Immune system disorders Hypersensitivity	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	2.0% 1/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	2.0% 1/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	2.0% 1/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	2.0% 1/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).
Psychiatric disorders Insomnia	2.0% 1/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).
Skin and subcutaneous tissue disorders Blister	2.0% 1/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	0.00% 0/51 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).	2.0% 1/50 • AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit. Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).

Additional Information

Gabriella Mariani

AstraZeneca

Phone: +44 7818 523 899

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60