Trial Outcomes & Findings for Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome (NCT NCT02365506)
NCT ID: NCT02365506
Last Updated: 2020-12-30
Results Overview
Daytime (AUC0-8)/8 was defined as the area under the QTc curve during the 8 hours postdose, where 0 was defined as the time of dosing (i.e., T = 0) on a given day. Daytime (AUC0-8)/8 was computed by dividing AUC0-8 by the time from dosing to the 8 hour postdose time point. QTcF is corrected QT interval using Fridericia's formula.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Baseline (Day 1), Day 3
Results posted on
2020-12-30
Participant Flow
Participants were enrolled at 1 study site in the United States. The first participant was screened on 20 July 2015. The last study visit occurred on 13 June 2016.
15 participants were screened.
Participant milestones
| Measure |
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Eleclazine 48 mg + Placebo
Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Placebo
Participants received placebo to match eleclazine tablets on Days 1 to 4.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Eleclazine 48 mg + Placebo
Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Placebo
Participants received placebo to match eleclazine tablets on Days 1 to 4.
|
|---|---|---|---|
|
Overall Study
Investigator's Discretion
|
0
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome
Baseline characteristics by cohort
| Measure |
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
n=4 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Eleclazine 48 mg + Placebo
n=4 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Placebo
n=5 Participants
Participants received placebo to match eleclazine tablets on Days 1 to 4.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
40 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
48 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
43 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 3Population: Participants in the Full Analysis Set (included all participants who took at least 1 dose of study drug and had standard 12-lead Day 3 QT measurements recorded) with available data were analyzed.
Daytime (AUC0-8)/8 was defined as the area under the QTc curve during the 8 hours postdose, where 0 was defined as the time of dosing (i.e., T = 0) on a given day. Daytime (AUC0-8)/8 was computed by dividing AUC0-8 by the time from dosing to the 8 hour postdose time point. QTcF is corrected QT interval using Fridericia's formula.
Outcome measures
| Measure |
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
n=4 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Eleclazine 48 mg + Placebo
n=3 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Placebo
n=4 Participants
Participants received placebo to match eleclazine tablets on Days 1 to 4.
|
|---|---|---|---|
|
Change From Baseline in Standard 12-Lead Electrocardiogram (ECG) Daytime QT Interval Corrected For Heart Rate Using The Fridericia Formula (QTcF) (AUC0-8)/8 at Day 3: Lead V5
Baseline
|
447.2 msec
Standard Deviation 5.32
|
468.3 msec
Standard Deviation 26.20
|
464.3 msec
Standard Deviation 20.50
|
|
Change From Baseline in Standard 12-Lead Electrocardiogram (ECG) Daytime QT Interval Corrected For Heart Rate Using The Fridericia Formula (QTcF) (AUC0-8)/8 at Day 3: Lead V5
Change at Day 3
|
-5.3 msec
Standard Deviation 8.31
|
0.4 msec
Standard Deviation 15.20
|
2.1 msec
Standard Deviation 7.71
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 3Population: Participants in the Full Analysis Set with available data were analyzed.
Daytime (AUC0-8)/8 was defined as the area under the QTc curve during the 8 hours postdose, where 0 was defined as the time of dosing (i.e.,T = 0) on a given day. Daytime (AUC0-8)/8 was computed by dividing AUC0-8 by the time from dosing to the 8 hour postdose time point. QTcF is corrected QT interval using Fridericia's formula.
Outcome measures
| Measure |
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
n=4 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Eleclazine 48 mg + Placebo
n=3 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Placebo
n=4 Participants
Participants received placebo to match eleclazine tablets on Days 1 to 4.
|
|---|---|---|---|
|
Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II
Baseline
|
447.7 msec
Standard Deviation 5.48
|
464.7 msec
Standard Deviation 34.00
|
461.2 msec
Standard Deviation 20.01
|
|
Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II
Change at Day 3
|
-3.4 msec
Standard Deviation 7.72
|
8.7 msec
Standard Deviation 8.96
|
3.3 msec
Standard Deviation 7.19
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 3Population: Participants in the Full Analysis Set with available data were analyzed.
Daytime (AUC0-8)/8 was defined as the area under the QTc curve during the 8 hours postdose, where 0 was defined as the time of dosing (i.e., T = 0) on a given day. Daytime (AUC0-8)/8 was computed by dividing AUC0-8 by the time from dosing to the 8 hour postdose time point. QTcF is corrected QT interval using Fridericia's formula.
Outcome measures
| Measure |
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
n=4 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Eleclazine 48 mg + Placebo
n=4 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Placebo
n=4 Participants
Participants received placebo to match eleclazine tablets on Days 1 to 4.
|
|---|---|---|---|
|
Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead
Baseline
|
453.3 msec
Standard Deviation 8.11
|
471.2 msec
Standard Deviation 41.88
|
477.9 msec
Standard Deviation 32.80
|
|
Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead
Change at Day 3
|
-7.8 msec
Standard Deviation 7.55
|
0.5 msec
Standard Deviation 9.68
|
-3.5 msec
Standard Deviation 3.90
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 3Population: Participants in the Full Analysis Set with available data were analyzed.
Daily Holter QTcF interval was calculated as the average of the daytime QTcF interval (AUC0-6)/6 and nocturnal QTcF interval (AUC0-6)/6. Daytime AUC0-6 was defined as the area under the QTc curve during the 6 hours postdose and nocturnal AUC0-6 was defined as the area under the QTc curve from midnight to 6am. (AUC0-6)/6 was computed by dividing AUC0-6 by the time difference over the 6 hours. QTcF is corrected QT interval using Fridericia's formula.
Outcome measures
| Measure |
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
n=3 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Eleclazine 48 mg + Placebo
n=3 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Placebo
n=4 Participants
Participants received placebo to match eleclazine tablets on Days 1 to 4.
|
|---|---|---|---|
|
Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Lead V5
Baseline
|
461.6 msec
Standard Deviation 6.89
|
466.6 msec
Standard Deviation 20.00
|
481.2 msec
Standard Deviation 28.12
|
|
Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Lead V5
Change at Day 3
|
3.5 msec
Standard Deviation 10.37
|
7.8 msec
Standard Deviation 2.20
|
-4.1 msec
Standard Deviation 13.77
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 3Population: Participants in the Full Analysis Set with available data were analyzed.
Daily Holter QTcF interval was calculated as the average of the daytime QTcF interval (AUC0-6)/6 and nocturnal QTcF interval (AUC0-6)/6. Daytime AUC0-6 was defined as the area under the QTc curve during the 6 hours postdose and nocturnal AUC0-6 was defined as the area under the QTc curve from midnight to 6am. (AUC0-6)/6 was computed by dividing AUC0-6 by the time difference over the 6 hours. QTcF is corrected QT interval using Fridericia's formula.
Outcome measures
| Measure |
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
n=3 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Eleclazine 48 mg + Placebo
n=4 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Placebo
n=4 Participants
Participants received placebo to match eleclazine tablets on Days 1 to 4.
|
|---|---|---|---|
|
Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Global Lead
Baseline
|
461.6 msec
Standard Deviation 7.85
|
483.3 msec
Standard Deviation 33.11
|
486.4 msec
Standard Deviation 28.03
|
|
Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Global Lead
Change at Day 3
|
3.2 msec
Standard Deviation 8.02
|
2.0 msec
Standard Deviation 3.81
|
-0.6 msec
Standard Deviation 14.67
|
SECONDARY outcome
Timeframe: Predose, Days 2 and 3Population: Participants in the Full Analysis Set with available data were analyzed.
Maximal reduction from predose (0 hour) is the maximum decrease from predose of the QTc interval (QTcF) at any time point from 1 to 8 hours postdose for Days 2 and 3. QTcF is corrected QT interval using Fridericia's formula. Predose was defined as the Day 2 predose value.
Outcome measures
| Measure |
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
n=4 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Eleclazine 48 mg + Placebo
n=3 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Placebo
n=4 Participants
Participants received placebo to match eleclazine tablets on Days 1 to 4.
|
|---|---|---|---|
|
Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5
Predose
|
450.6 msec
Standard Deviation 13.00
|
481.6 msec
Standard Deviation 33.28
|
453.9 msec
Standard Deviation 20.31
|
|
Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5
Day 2
|
-14.3 msec
Standard Deviation 7.82
|
-40.3 msec
Standard Deviation 20.85
|
-9.4 msec
Standard Deviation 14.11
|
|
Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5
Day 3
|
-16.3 msec
Standard Deviation 5.80
|
-64.4 msec
Standard Deviation 75.73
|
2.8 msec
Standard Deviation 15.57
|
SECONDARY outcome
Timeframe: Predose, Days 2 and 3Population: Participants in the Full Analysis Set with available data were analyzed.
Maximal reduction from predose is the maximum decrease from predose of the QTc interval (QTcF) at any time point from 1 to 8 hours postdose for Days 2 and 3. QTcF is corrected QT interval using Fridericia's formula. Predose was defined as the Day 2 predose value.
Outcome measures
| Measure |
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
n=4 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Eleclazine 48 mg + Placebo
n=3 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Placebo
n=4 Participants
Participants received placebo to match eleclazine tablets on Days 1 to 4.
|
|---|---|---|---|
|
Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II
Predose
|
458.3 msec
Standard Deviation 11.54
|
482.1 msec
Standard Deviation 37.67
|
455.8 msec
Standard Deviation 21.61
|
|
Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II
Day 2
|
-16.5 msec
Standard Deviation 9.34
|
-37.1 msec
Standard Deviation 37.79
|
-9.1 msec
Standard Deviation 18.40
|
|
Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II
Day 3
|
-21.5 msec
Standard Deviation 6.14
|
-35.8 msec
Standard Deviation 24.15
|
-1.7 msec
Standard Deviation 18.06
|
SECONDARY outcome
Timeframe: Predose, Days 2 and 3Population: Participants in the Full Analysis Set with available data were analyzed.
Maximal reduction from predose is the maximum decrease from predose of the QTc interval (QTcF) at any time point from 1 to 8 hours postdose for Days 2 and 3. QTcF is corrected QT interval using Fridericia's formula. Predose was defined as the Day 2 predose value.
Outcome measures
| Measure |
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
n=4 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Eleclazine 48 mg + Placebo
n=4 Participants
Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Placebo
n=4 Participants
Participants received placebo to match eleclazine tablets on Days 1 to 4.
|
|---|---|---|---|
|
Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead
Predose
|
458.8 msec
Standard Deviation 14.60
|
473.5 msec
Standard Deviation 42.27
|
461.7 msec
Standard Deviation 24.49
|
|
Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead
Day 2
|
-18.3 msec
Standard Deviation 8.31
|
-13.5 msec
Standard Deviation 6.92
|
-4.6 msec
Standard Deviation 17.12
|
|
Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead
Day 3
|
-23.3 msec
Standard Deviation 6.10
|
-15.7 msec
Standard Deviation 14.01
|
2.1 msec
Standard Deviation 11.29
|
Adverse Events
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Eleclazine 48 mg + Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eleclazine 24 mg + Eleclazine 48 mg + Placebo
n=4 participants at risk
Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Eleclazine 48 mg + Placebo
n=4 participants at risk
Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
|
Placebo
n=5 participants at risk
Participants received placebo to match eleclazine tablets on Days 1 to 4.
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
60.0%
3/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER