Trial Outcomes & Findings for RDEA3170 Bioavailability Study (NCT NCT02336594)
NCT ID: NCT02336594
Last Updated: 2017-10-13
Results Overview
Cmax of RDEA3170 in fasted condition.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Results posted on
2017-10-13
Participant Flow
15 subjects were randomized
Fifteen subjects were randomized to 1 of 4 treatment sequences (ABCD, BACD, ABDC, BADC) in a 1:1:1:1 ratio.
Participant milestones
| Measure |
Sequence ABCD
Day 1 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 5 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 9 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal); Day 13 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal).
|
Sequence BACD
Day 1 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 5 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 9 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal); Day 13 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal).
|
Sequence ABDC
Day 1 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 5 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 9 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal); Day 13 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal).
|
Sequence BADC
Day 1 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 5 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 9 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal); Day 13 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RDEA3170 Bioavailability Study
Baseline characteristics by cohort
| Measure |
Sequence ABCD
n=3 Participants
2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat.
|
Sequence BACD
n=4 Participants
10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat
|
Sequence ABDC
n=4 Participants
2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
|
Sequence BADC
n=4 Participants
10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
39 Years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
40 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
42 Years
STANDARD_DEVIATION 16.0 • n=4 Participants
|
42 Years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
Age, Customized
<65
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Age, Customized
>=65
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.Cmax of RDEA3170 in fasted condition.
Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
14.1 ng/mL
Interval 11.7 to 16.8
|
14.9 ng/mL
Interval 11.9 to 18.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.Tmax of RDEA3170 following various treatments.
Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
Time of Occurrence of Maximum Observed Concentration (Tmax)
|
2.00 hr
Interval 1.0 to 6.0
|
2.00 hr
Interval 1.0 to 4.0
|
2.00 hr
Interval 1.0 to 6.0
|
4.00 hr
Interval 1.5 to 8.0
|
PRIMARY outcome
Timeframe: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.AUC last of RDEA3170 in fasted condition.
Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
|
119 ng·hr/mL
Interval 96.8 to 146.0
|
114 ng·hr/mL
Interval 85.7 to 153.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.AUC∞ of RDEA3170 the fasted condition.
Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
|
131 ng·hr/mL
Interval 105.0 to 164.0
|
130 ng·hr/mL
Interval 95.9 to 176.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.t1/2 of RDEA3170 following various treatments.
Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2)
|
16.5 hr
Interval 11.6 to 23.4
|
15.5 hr
Interval 10.6 to 22.5
|
15.4 hr
Interval 11.6 to 20.4
|
16.6 hr
Interval 11.5 to 23.9
|
PRIMARY outcome
Timeframe: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.Cmax of RDEA3170 in high-fat fed state.
Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets
|
14.9 ng/mL
Interval 11.9 to 18.8
|
27.2 ng/mL
Interval 20.2 to 36.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.AUC last of RDEA3170 in high-fat fed state.
Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets
|
114 ng·hr/mL
Interval 85.7 to 153.0
|
160 ng·hr/mL
Interval 130.0 to 199.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.AUC∞ of RDEA3170 in high-fat fed state.
Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets
|
130 ng·hr/mL
Interval 95.9 to 176.0
|
173 ng·hr/mL
Interval 137.0 to 219.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.Cmax of RDEA3170 in low-fat fed state.
Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
|
14.9 ng/mL
Interval 11.9 to 18.8
|
11.8 ng/mL
Interval 9.23 to 15.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.AUC last of RDEA3170 in low-fat fed state.
Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
|
114 ng·hr/mL
Interval 85.7 to 153.0
|
97.8 ng·hr/mL
Interval 77.3 to 124.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.AUC∞ of RDEA3170 in low-fat fed state.
Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
|
130 ng·hr/mL
Interval 95.9 to 176.0
|
108 ng·hr/mL
Interval 84.4 to 139.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.PD profiles of uric acid from serum and urine. PD parameters were evaluated to assess whether any potential differences in PK for the 2 different tablets resulted in differences in uric acid excretion.
Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine
Fractional Excretion of Uric Acid % Change (0-24h)
|
159 Percent
Standard Error 15.1
|
151 Percent
Standard Error 22.0
|
149 Percent
Standard Error 22.7
|
199 Percent
Standard Error 23.2
|
|
Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine
Serum Urate Maximum % Change
|
-34.4 Percent
Standard Error 2.08
|
-34.4 Percent
Standard Error 2.27
|
-37.3 Percent
Standard Error 1.89
|
-49.0 Percent
Standard Error 1.96
|
|
Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine
Urine Uric Acid % Change(0-24h)
|
96.6 Percent
Standard Error 12.5
|
78.5 Percent
Standard Error 8.38
|
53.4 Percent
Standard Error 8.85
|
65.9 Percent
Standard Error 9.70
|
|
Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine
Renal Clearance of Uric Acid % Change (0-24h)
|
170 Percent
Standard Error 19.5
|
147 Percent
Standard Error 15.6
|
128 Percent
Standard Error 18.9
|
179 Percent
Standard Error 21.5
|
SECONDARY outcome
Timeframe: 7 weeks.Outcome measures
| Measure |
Treatment A
n=15 Participants
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
n=15 Participants
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
|
0 Number of Participants
|
1 Number of Participants
|
1 Number of Participants
|
3 Number of Participants
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment D
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 |
Treatment A
n=15 participants at risk
10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
|
Treatment B
n=15 participants at risk
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
|
Treatment C
n=15 participants at risk
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
|
Treatment D
n=15 participants at risk
10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
6.7%
1/15 • Number of events 1 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
13.3%
2/15 • Number of events 2 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
6.7%
1/15 • Number of events 1 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/15 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
6.7%
1/15 • Number of events 1 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
6.7%
1/15 • Number of events 1 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15 • 7 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15 • 7 weeks
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