Trial Outcomes & Findings for A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 894416 in the Blood (NCT NCT04060719)
NCT ID: NCT04060719
Last Updated: 2023-08-14
Results Overview
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Within 3 hours before administration of BI 894416 and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34 and 48 hours after administration of BI 894416.
Results posted on
2023-08-14
Participant Flow
Open-label, 2-treatment, 2-period, 1-way crossover trial to compare the test treatment (T) to the reference treatment (R). The treatments were 1 single dose of BI 894416 following 7 days of pretreatment with rifampicin (T) and 1 single dose of BI 894416 given alone (R) with a washout period of at least 10 days between administrations of BI 894416.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
BI 894416 Alone (Reference)/BI 894416 + Rifampicin (Test)
In treatment period 1, Day 1, participants were administered one oral single dose of 50 milligram (mg) BI 894416 as tablet formulation (2 tablets of 25 mg administered in the fasting state with 240 milliliter (mL) of water) (reference treatment in period 1, Reference). In treatment period 2, from Day -7 to Day -1, participants were administered one film-coated tablet of 600 mg rifampicin with 240 mL of water once daily, followed by one oral single dose of 50 mg BI 894416 as tablet formulation (2 tablets of 25 mg administered in the fasting state with 240 mL of water) on Day 1 (test treatment in period 2, Test). There was a washout period of at least 10 days between the administrations of BI 894416.
|
|---|---|
|
Period 1
STARTED
|
16
|
|
Period 1
COMPLETED
|
16
|
|
Period 1
NOT COMPLETED
|
0
|
|
Washout Period
STARTED
|
16
|
|
Washout Period
COMPLETED
|
16
|
|
Washout Period
NOT COMPLETED
|
0
|
|
Period 2
STARTED
|
16
|
|
Period 2
COMPLETED
|
16
|
|
Period 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 894416 in the Blood
Baseline characteristics by cohort
| Measure |
BI 894416 Alone (Reference)/BI 894416 + Rifampicin (Test)
n=16 Participants
In treatment period 1, Day 1, participants were administered one oral single dose of 50 milligram (mg) BI 894416 as tablet formulation (2 tablets of 25 mg administered in the fasting state with 240 milliliter (mL) of water) (reference treatment in period 1, Reference). In treatment period 2, from Day -7 to Day -1, participants were administered one film-coated tablet of 600 mg rifampicin with 240 mL of water once daily, followed by one oral single dose of 50 mg BI 894416 as tablet formulation (2 tablets of 25 mg administered in the fasting state with 240 mL of water) on Day 1 (test treatment in period 2, Test). There was a washout period of at least 10 days between the administrations of BI 894416.
|
|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours before administration of BI 894416 and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34 and 48 hours after administration of BI 894416.Population: Pharmacokinetic (PK) parameter analysis set (PKS) included all participants who were treated with at least 1 dose of trial drug and provided at least 1 PK endpoint defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
BI 894416 Alone (Reference, R)
n=16 Participants
In treatment period 1, Day 1, participants were administered one oral single dose of 50 milligram (mg) BI 894416 as tablet formulation (2 tablets of 25 mg administered in the fasting state with 240 milliliter (mL) of water) (reference treatment in period 1, Reference).
|
BI 894416 + Rifampicin (Test, T)
n=16 Participants
In treatment period 2, from Day -7 to Day -1, participants were administered one film-coated tablet of 600 mg rifampicin with 240 mL of water once daily, followed by one oral single dose of 50 mg BI 894416 as tablet formulation (2 tablets of 25 mg administered in the fasting state with 240 mL of water) on Day 1 (test treatment in period 2, Test).
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|---|---|---|
|
Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
9077.08 hour * nanomole / liter
Standard Error NA
Geometric Standard Error (gSE) = 1.09
|
951.58 hour * nanomole / liter
Standard Error NA
Geometric Standard Error (gSE) = 1.09
|
PRIMARY outcome
Timeframe: Within 3 hours before administration of BI 894416 and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34 and 48 hours after administration of BI 894416.Population: Pharmacokinetic (PK) parameter analysis set (PKS) included all participants who were treated with at least 1 dose of trial drug and provided at least 1 PK endpoint defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 894416 in plasma (Cmax).
Outcome measures
| Measure |
BI 894416 Alone (Reference, R)
n=16 Participants
In treatment period 1, Day 1, participants were administered one oral single dose of 50 milligram (mg) BI 894416 as tablet formulation (2 tablets of 25 mg administered in the fasting state with 240 milliliter (mL) of water) (reference treatment in period 1, Reference).
|
BI 894416 + Rifampicin (Test, T)
n=16 Participants
In treatment period 2, from Day -7 to Day -1, participants were administered one film-coated tablet of 600 mg rifampicin with 240 mL of water once daily, followed by one oral single dose of 50 mg BI 894416 as tablet formulation (2 tablets of 25 mg administered in the fasting state with 240 mL of water) on Day 1 (test treatment in period 2, Test).
|
|---|---|---|
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Maximum Measured Concentration of BI 894416 in Plasma (Cmax)
|
1624.79 nanomole / liter
Standard Error NA
Geometric Standard Error (gSE) = 1.10
|
487.98 nanomole / liter
Standard Error NA
Geometric Standard Error (gSE) = 1.10
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SECONDARY outcome
Timeframe: Within 3 hours before administration of BI 894416 and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34 and 48 hours after administration of BI 894416.Population: Pharmacokinetic (PK) parameter analysis set (PKS) included all participants who were treated with at least 1 dose of trial drug and provided at least 1 PK endpoint defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Outcome measures
| Measure |
BI 894416 Alone (Reference, R)
n=16 Participants
In treatment period 1, Day 1, participants were administered one oral single dose of 50 milligram (mg) BI 894416 as tablet formulation (2 tablets of 25 mg administered in the fasting state with 240 milliliter (mL) of water) (reference treatment in period 1, Reference).
|
BI 894416 + Rifampicin (Test, T)
n=16 Participants
In treatment period 2, from Day -7 to Day -1, participants were administered one film-coated tablet of 600 mg rifampicin with 240 mL of water once daily, followed by one oral single dose of 50 mg BI 894416 as tablet formulation (2 tablets of 25 mg administered in the fasting state with 240 mL of water) on Day 1 (test treatment in period 2, Test).
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
9047.51 hour * nanomole / liter
Standard Error NA
Geometric Standard Error (gSE) = 1.09
|
939.98 hour * nanomole / liter
Standard Error NA
Geometric Standard Error (gSE) = 1.09
|
Adverse Events
BI 894416 (Reference)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Rifampicin
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
BI 894416 + Rifampicin (Test)
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 |
BI 894416 (Reference)
n=16 participants at risk
In treatment period 1, Day 1, participants were administered one oral single dose of 50 milligram (mg) BI 894416 as tablet formulation (2 tablets of 25 mg administered in the fasting state with 240 milliliter (mL) of water) (reference treatment in period 1, Reference).
|
Rifampicin
n=16 participants at risk
In treatment period 2, from Day -7 to Day -1, participants were treated with 600 mg rifampicin once daily as tablet formulation (1 film-coated tablet of 600 mg administered with 240 mL of water).
|
BI 894416 + Rifampicin (Test)
n=16 participants at risk
In treatment period 2, from Day -7 to Day -1, participants were administered one film-coated tablet of 600 mg rifampicin with 240 mL of water once daily, followed by one oral single dose of 50 mg BI 894416 as tablet formulation (2 tablets of 25 mg administered in the fasting state with 240 mL of water) on Day 1 (test treatment in period 2, Test).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
6.2%
1/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
General disorders
Feeling hot
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
6.2%
1/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
6.2%
1/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
6.2%
1/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
6.2%
1/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
6.2%
1/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
18.8%
3/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
100.0%
16/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of upper respiratory secretion
|
6.2%
1/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/16 • BI 894416 (Reference): From treatment with BI 894416 in treatment period 1 until first treatment with rifampicin in treatment period 2, up to 3 days. Rifampicin: From first treatment with rifampicin in treatment period 2 until treatment with BI 894416 in treatment period 2, up to 7 days. BI 894416 + Rifampicin (Test): From treatment with BI 894416 in treatment period 2 until the individual paricipant's end of trial, up to 15 days.
The treated set included all participants who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER