Trial Outcomes & Findings for RDEA3170 and Allopurinol Combination Study in Gout Subjects (NCT NCT02279641)
NCT ID: NCT02279641
Last Updated: 2017-12-20
Results Overview
Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
22 days
Results posted on
2017-12-20
Participant Flow
12 subjects were randomized
Twelve subjects were randomized to 1 of 2 treatment sequences (Sequence A or B) in a 1:1 ratio.
Participant milestones
| Measure |
RDEA3170 or Allopurinol Alone and in Combination (Sequence A)
Days 1 to 7: 10 mg once daily (qd) RDEA3170; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 300 mg qd allopurinol
|
RDEA3170 or Allopurinol Alone and in Combination (Sequence B)
Days 1 to 7: 300 mg qd allopurinol; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 10 mg qd RDEA3170
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RDEA3170 and Allopurinol Combination Study in Gout Subjects
Baseline characteristics by cohort
| Measure |
Sequence A
n=6 Participants
Days 1 to 7: 10 mg once daily (qd) RDEA3170; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 300 mg qd allopurinol
|
Sequence B
n=6 Participants
Days 1 to 7: 300 mg qd allopurinol; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 10 mg qd RDEA3170
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
49 Years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
51 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Age, Customized
<65
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Customized
>=65
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 22 daysCmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Outcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
1.13 μg/mL
Interval 0.894 to 1.43
|
1.51 μg/mL
Interval 1.24 to 1.82
|
12.8 μg/mL
Interval 11.7 to 14.0
|
8.68 μg/mL
Interval 7.99 to 9.43
|
—
|
—
|
PRIMARY outcome
Timeframe: 22 daysTmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Outcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
n=12 Participants
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Time of Occurrence of Maximum Observed Concentration (Tmax)
|
1.50 hr
Interval 1.0 to 4.0
|
1.25 hr
Interval 0.5 to 4.0
|
4.00 hr
Interval 1.5 to 6.0
|
3.50 hr
Interval 1.5 to 8.0
|
3.00 hr
Interval 1.5 to 4.0
|
3.00 hr
Interval 2.0 to 10.0
|
PRIMARY outcome
Timeframe: 22 daysAUC 0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Outcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
n=12 Participants
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
|
3.69 μg·hr/mL
Interval 3.24 to 4.21
|
3.68 μg·hr/mL
Interval 3.28 to 4.13
|
255 μg·hr/mL
Interval 229.0 to 284.0
|
157 μg·hr/mL
Interval 140.0 to 177.0
|
115 μg·hr/mL
Interval 96.5 to 137.0
|
—
|
PRIMARY outcome
Timeframe: 22 daysAUC last of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Outcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
|
3.50 μg·hr/mL
Interval 3.04 to 4.04
|
3.61 μg·hr/mL
Interval 3.22 to 4.05
|
255 μg·hr/mL
Interval 229.0 to 284.0
|
157 μg·hr/mL
Interval 140.0 to 177.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 22 dayst1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Outcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
n=12 Participants
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2)
|
1.06 hr
Interval 0.969 to 1.15
|
0.992 hr
Interval 0.89 to 1.1
|
43.2 hr
Interval 36.1 to 51.7
|
29.1 hr
Interval 23.9 to 35.4
|
11.5 hr
Interval 8.43 to 15.6
|
12.5 hr
Interval 8.99 to 17.4
|
PRIMARY outcome
Timeframe: 22 daysAe0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Outcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
|
25.4 mg
Interval 22.1 to 29.2
|
22.7 mg
Interval 19.2 to 26.9
|
231 mg
Interval 216.0 to 248.0
|
275 mg
Interval 262.0 to 290.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 22 daysCLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Outcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
n=12 Participants
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)
|
120 mL/min
Interval 106.0 to 135.0
|
103 mL/min
Interval 87.1 to 122.0
|
15.1 mL/min
Interval 13.0 to 17.6
|
29.2 mL/min
Interval 25.1 to 33.9
|
9.28 mL/min
Interval 7.43 to 11.6
|
9.75 mL/min
Interval 7.73 to 12.3
|
PRIMARY outcome
Timeframe: 22 daysOutcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
Serum Urate Maximum % Change
|
-50.5 Percentage (%)
Standard Error 2.43 • Interval 13.0 to 17.6
|
-65.2 Percentage (%)
Standard Error 1.57 • Interval 25.1 to 33.9
|
-43.0 Percentage (%)
Standard Error 1.57 • Interval 7.43 to 11.6
|
—
|
—
|
—
|
|
Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
Urine Uric Acid % Change (0-24h)
|
9.88 Percentage (%)
Standard Error 7.61
|
-21.6 Percentage (%)
Standard Error 5.58
|
-47.4 Percentage (%)
Standard Error 2.67
|
—
|
—
|
—
|
|
Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
Renal Clearance of Uric Acid % Change (0-24h)
|
122 Percentage (%)
Standard Error 46.8
|
125 Percentage (%)
Standard Error 42.2
|
-8.50 Percentage (%)
Standard Error 6.04
|
—
|
—
|
—
|
|
Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
Fract. Excretion of Uric Acid % Change (0-24h)
|
77.4 Percentage (%)
Standard Error 18.0
|
78.4 Percentage (%)
Standard Error 21.9
|
-12.0 Percentage (%)
Standard Error 5.46
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 22 daysCmax of RDEA3170 Alone and In Combination with Allopurinol
Outcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
14.6 ng/mL
Interval 12.2 to 17.5
|
14.5 ng/mL
Interval 11.7 to 17.9
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 22 daysAUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol
Outcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
|
120 μg*hr/mL
Interval 98.1 to 147.0
|
115 μg*hr/mL
Interval 96.5 to 137.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 22 daysAUC last of RDEA3170 Alone and In Combination with Allopurinol
Outcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
|
120 ng·hr/mL
Interval 98.1 to 147.0
|
115 ng·hr/mL
Interval 96.5 to 137.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 22 daysAe0-24 of RDEA3170 Alone and In Combination with Allopurinol
Outcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
|
66.8 ug
Interval 51.8 to 86.1
|
67.2 ug
Interval 51.7 to 87.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 22 daysOutcome measures
| Measure |
Allopurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Allopurinol: RDEA3170 + Allopurinol
n=12 Participants
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Oxypurinol: Allopurinol Alone
n=12 Participants
Allopurinol 300 mg qd
|
Oxypurinol: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
RDEA3170: RDEA3170 Alone
RDEA3170 10 mg qd
|
RDEA3170: RDEA3170 + Allopurinol
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
|---|---|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
|
2 Number of participants
2.43 • Interval 13.0 to 17.6
|
1 Number of participants
1.57 • Interval 25.1 to 33.9
|
3 Number of participants
1.57 • Interval 7.43 to 11.6
|
—
|
—
|
—
|
Adverse Events
RDEA3170 10 mg qd
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Allopurinol 300 mg qd
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RDEA3170 10 mg qd
n=12 participants at risk
RDEA3170 10 mg qd
|
RDEA3170 10 mg qd + Allopurinol 300 mg qd
n=12 participants at risk
RDEA3170 10 mg qd + Allopurinol 300 mg qd
|
Allopurinol 300 mg qd
n=12 participants at risk
Allopurinol 300 mg qd
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
8.3%
1/12 • Number of events 1 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
8.3%
1/12 • Number of events 1 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Number of events 1 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
8.3%
1/12 • Number of events 1 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
8.3%
1/12 • Number of events 1 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
8.3%
1/12 • Number of events 1 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 1 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/12 • 22 days
Overall number of baseline participants used to determine number of participants at risk.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER