Trial Outcomes & Findings for A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus. (NCT NCT03555994)
NCT ID: NCT03555994
Last Updated: 2024-11-12
Results Overview
To assess the effect of MEDI0382 on hepatic glycogen levels postprandially versus placebo after 28 days of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Day -1 to Day 28
Results posted on
2024-11-12
Participant Flow
In Part A, a total of 21 participants participated in the study from 31 May 2018 (date first participant enrolled for Part A) to 23 November 2018 (date of last participant last visit for Part A) at one site in Sweden. In Part B, a total of 30 participants participated in the study from 17 December 2019 (date first participant enrolled for Part B) to 14 April 2021 (date of last participant last visit for Part B) at 2 sites (one in Sweden and one in the Netherlands).
Participant milestones
| Measure |
Placebo (Part A)
Placebo administered subcutaneously (Part A)
|
MEDI0382 (Part A)
MEDI0382 administered subcutaneously (Part A)
|
Liraglutide (Part B)
Active Comparator administered subcutaneously (Part B)
|
MEDI0382 (Part B)
MEDI0382 administered subcutaneously (Part B)
|
Placebo (Part B)
Placebo administered subcutaneously (Part B)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
10
|
9
|
11
|
|
Overall Study
COMPLETED
|
9
|
10
|
10
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
Baseline characteristics by cohort
| Measure |
Placebo (Part A)
n=9 Participants
Placebo administered subcutaneously (Part A)
|
MEDI0382 (Part A)
n=12 Participants
MEDI0382 administered subcutaneously (Part A)
|
Liraglutide (Part B)
n=10 Participants
Active Comparator administered subcutaneously (Part B)
|
MEDI0382 (Part B)
n=9 Participants
MEDI0382 administered subcutaneously (Part B)
|
Placebo (Part B)
n=11 Participants
Placebo administered subcutaneously (Part B)
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
Age
|
69.3 Years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
65.8 Years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
65.2 Years
STANDARD_DEVIATION 9.1 • n=206 Participants
|
61.8 Years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
64.0 Years
STANDARD_DEVIATION 10.7 • n=31 Participants
|
65.2 Years
STANDARD_DEVIATION 8.2 • n=30 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
17 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
34 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
51 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Day -1 to Day 28To assess the effect of MEDI0382 on hepatic glycogen levels postprandially versus placebo after 28 days of treatment
Outcome measures
| Measure |
Placebo (Part A)
n=9 Participants
Placebo administered subcutaneously (Part A)
|
MEDI0382 (Part A)
n=10 Participants
MEDI0382 administered subcutaneously (Part A)
|
Placebo (Part B)
Placebo administered subcutaneously (Part B)
|
Liraglutide
Active comparator administered subcutaneously (Part B)
|
Placebo (Part B)
Placebo administered subcutaneously (Part B)
|
|---|---|---|---|---|---|
|
Change in Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 4 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 28 Days of Treatment (Part A Only)
|
5.5 mmol/L
Interval -47.2 to 58.3
|
-100.2 mmol/L
Interval -150.2 to -50.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -1 to Day 36To assess the effect of MEDI0382 on hepatic glycogen levels versus placebo after 35 days (Part B) of treatment
Outcome measures
| Measure |
Placebo (Part A)
n=9 Participants
Placebo administered subcutaneously (Part A)
|
MEDI0382 (Part A)
n=11 Participants
MEDI0382 administered subcutaneously (Part A)
|
Placebo (Part B)
Placebo administered subcutaneously (Part B)
|
Liraglutide
Active comparator administered subcutaneously (Part B)
|
Placebo (Part B)
Placebo administered subcutaneously (Part B)
|
|---|---|---|---|---|---|
|
Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 35 Days of Treatment (Day 36) (Part B)
|
-27.02 percent change from baseline
Interval -38.04 to -16.01
|
-1.15 percent change from baseline
Interval -11.09 to 8.79
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Fom baseline (Day -1) to Day 35To assess the effect of MEDI0382 on hepatic glycogen levels versus liraglutide after 35 days of treatment (Part B only)
Outcome measures
| Measure |
Placebo (Part A)
n=10 Participants
Placebo administered subcutaneously (Part A)
|
MEDI0382 (Part A)
n=9 Participants
MEDI0382 administered subcutaneously (Part A)
|
Placebo (Part B)
Placebo administered subcutaneously (Part B)
|
Liraglutide
Active comparator administered subcutaneously (Part B)
|
Placebo (Part B)
Placebo administered subcutaneously (Part B)
|
|---|---|---|---|---|---|
|
Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day 1) to the End of 35 Days of Treatment (Day 36, Part B Only)
|
-5.33 percentage change from baseline
Interval -13.97 to 3.32
|
-27.31 percentage change from baseline
Interval -36.42 to -18.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -1 to Day 36Outcome measures
| Measure |
Placebo (Part A)
n=10 Participants
Placebo administered subcutaneously (Part A)
|
MEDI0382 (Part A)
n=9 Participants
MEDI0382 administered subcutaneously (Part A)
|
Placebo (Part B)
n=11 Participants
Placebo administered subcutaneously (Part B)
|
Liraglutide
Active comparator administered subcutaneously (Part B)
|
Placebo (Part B)
Placebo administered subcutaneously (Part B)
|
|---|---|---|---|---|---|
|
Change of Hepatic Fat Fraction From Baseline as Measured by Magnetic Resonance Imaging (Day -1) to the End of 35 Days of Treatment (Part B Only)
|
-15.40 percent
Interval -21.09 to -9.72
|
-26.26 percent
Interval -51.13 to -1.39
|
8.79 percent
Interval -10.46 to 28.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to (Follow-up Period) 28 days post last dose + (3-month poststudy)Outcome measures
| Measure |
Placebo (Part A)
n=9 Participants
Placebo administered subcutaneously (Part A)
|
MEDI0382 (Part A)
n=12 Participants
MEDI0382 administered subcutaneously (Part A)
|
Placebo (Part B)
n=9 Participants
Placebo administered subcutaneously (Part B)
|
Liraglutide
n=10 Participants
Active comparator administered subcutaneously (Part B)
|
Placebo (Part B)
n=11 Participants
Placebo administered subcutaneously (Part B)
|
|---|---|---|---|---|---|
|
Development of ADA
Baseline ADA result
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Development of ADA
Day 28 ADA result for Part A Day 35 ADA result for Part B
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Development of ADA
Follow-up ADA result
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Development of ADA
Post Study ADA result
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post dosing (Day 1) to final follow-up (28 Days post last dose)Safety and tolerability of daily SC doses of MEDI0382 by assessment of the following using CTCAE V4.0: The number of Treatment Emergent Adverse events (TEAEs)
Outcome measures
| Measure |
Placebo (Part A)
n=9 Participants
Placebo administered subcutaneously (Part A)
|
MEDI0382 (Part A)
n=12 Participants
MEDI0382 administered subcutaneously (Part A)
|
Placebo (Part B)
n=10 Participants
Placebo administered subcutaneously (Part B)
|
Liraglutide
n=9 Participants
Active comparator administered subcutaneously (Part B)
|
Placebo (Part B)
n=11 Participants
Placebo administered subcutaneously (Part B)
|
|---|---|---|---|---|---|
|
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants withTreatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE V4.0
At least one event
|
7 Participants
|
11 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
|
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants withTreatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE V4.0
At least one IP related event
|
5 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Post dosing (Day 1) to final follow-up (28 Days post last dose)Safety and tolerability of daily SC doses of MEDI0382 by assessment of the following using CTCAE V4.0: The number of Treatment-Emergent Serious Adverse Events (TESAEs)
Outcome measures
| Measure |
Placebo (Part A)
n=9 Participants
Placebo administered subcutaneously (Part A)
|
MEDI0382 (Part A)
n=12 Participants
MEDI0382 administered subcutaneously (Part A)
|
Placebo (Part B)
n=10 Participants
Placebo administered subcutaneously (Part B)
|
Liraglutide
n=9 Participants
Active comparator administered subcutaneously (Part B)
|
Placebo (Part B)
n=11 Participants
Placebo administered subcutaneously (Part B)
|
|---|---|---|---|---|---|
|
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) as Assessed by CTCAE V4.0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post dosing (Day 1) to final follow-up (28 Days post last dose)Number of subjects with clinically significant changes in heart rate (BPM) or systolic and diastolic blood pressure (mmHg)
Outcome measures
| Measure |
Placebo (Part A)
n=9 Participants
Placebo administered subcutaneously (Part A)
|
MEDI0382 (Part A)
n=12 Participants
MEDI0382 administered subcutaneously (Part A)
|
Placebo (Part B)
n=10 Participants
Placebo administered subcutaneously (Part B)
|
Liraglutide
n=9 Participants
Active comparator administered subcutaneously (Part B)
|
Placebo (Part B)
n=11 Participants
Placebo administered subcutaneously (Part B)
|
|---|---|---|---|---|---|
|
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Heart Rate and Blood Pressure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post dosing (Day 1) to final follow-up (28 Days post last dose)Population: As-treated population
Number of subjects with an ECG determined to be abnormal and clinically significant
Outcome measures
| Measure |
Placebo (Part A)
n=9 Participants
Placebo administered subcutaneously (Part A)
|
MEDI0382 (Part A)
n=12 Participants
MEDI0382 administered subcutaneously (Part A)
|
Placebo (Part B)
n=10 Participants
Placebo administered subcutaneously (Part B)
|
Liraglutide
n=9 Participants
Active comparator administered subcutaneously (Part B)
|
Placebo (Part B)
n=11 Participants
Placebo administered subcutaneously (Part B)
|
|---|---|---|---|---|---|
|
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in ECG
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post dosing (Day 1) to final follow-up (28 Days post last dose)Number of subjects with clinically significant changes in in haematology and or clinical chemistry parameters
Outcome measures
| Measure |
Placebo (Part A)
n=9 Participants
Placebo administered subcutaneously (Part A)
|
MEDI0382 (Part A)
n=12 Participants
MEDI0382 administered subcutaneously (Part A)
|
Placebo (Part B)
n=10 Participants
Placebo administered subcutaneously (Part B)
|
Liraglutide
n=9 Participants
Active comparator administered subcutaneously (Part B)
|
Placebo (Part B)
n=11 Participants
Placebo administered subcutaneously (Part B)
|
|---|---|---|---|---|---|
|
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Haematology and Clinical Chemistry Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo (Part A)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MEDI0382 (Part A)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Liraglutide (Part B)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
MEDI0382 (Part B)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo (Part B)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (Part A)
n=9 participants at risk
Placebo comparator administered subcutaneously (Part A)
|
MEDI0382 (Part A)
n=12 participants at risk
MEDI0382 administered subcutaneously (Part A)
|
Liraglutide (Part B)
n=10 participants at risk
Active Comparator administered subcutaneously (Part B)
|
MEDI0382 (Part B)
n=9 participants at risk
MEDI0382 administered subcutaneously (Part B)
|
Placebo (Part B)
n=11 participants at risk
Placebo administered subcutaneously (Part B)
|
|---|---|---|---|---|---|
|
General disorders
Early satiety
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
General disorders
Fatigue
|
22.2%
2/9 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
50.0%
6/12 • Number of events 6 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
33.3%
3/9 • Number of events 3 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
General disorders
Feeling cold
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
General disorders
Injection site erythema
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
General disorders
Injection site haematoma
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
General disorders
Injection site rash
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
16.7%
2/12 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
General disorders
Pain
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Investigations
Heart rate increased
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
25.0%
3/12 • Number of events 3 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
20.0%
2/10 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Metabolism and nutrition disorders
Food craving
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Eye disorders
Vision blurred
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
25.0%
3/12 • Number of events 3 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
20.0%
2/10 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
9.1%
1/11 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Nervous system disorders
Headache
|
33.3%
3/9 • Number of events 3 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
41.7%
5/12 • Number of events 5 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 3 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
9.1%
1/11 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Psychiatric disorders
Apathy
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Psychiatric disorders
Daydreaming
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
22.2%
2/9 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Psychiatric disorders
Irritability
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
18.2%
2/11 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Eye disorders
Visual impairment
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
9.1%
1/11 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
9.1%
1/11 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
9.1%
1/11 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
9.1%
1/11 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
16.7%
2/12 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
16.7%
2/12 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
16.7%
2/12 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
9.1%
1/11 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
25.0%
3/12 • Number of events 3 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
20.0%
2/10 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
22.2%
2/9 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
2/9 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
9.1%
1/11 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
8.3%
1/12 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/10 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Dyspepsia
|
22.2%
2/9 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
50.0%
6/12 • Number of events 6 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
20.0%
2/10 • Number of events 3 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
66.7%
8/12 • Number of events 8 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 42 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
55.6%
5/9 • Number of events 98 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
41.7%
5/12 • Number of events 5 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 14 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
11.1%
1/9 • Number of events 42 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
General disorders
Asthenia
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/12 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
|
General disorders
Chills
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
16.7%
2/12 • Number of events 2 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
10.0%
1/10 • Number of events 1 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/9 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
0.00%
0/11 • Post dosing (Day 1) to final follow-up (28 Days post last dose)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding study results for a period that is more than 60 days but less than or equal to 180 days from the date that the communication is submitted to the sponsor for review. The sponsor can make comments and suggestions where pertinent to the communication and the Sponsor can request for an exceptional additional delay.
- Publication restrictions are in place
Restriction type: OTHER