A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03907280
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 3
• Actual Duration (Months): 7.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The main objective of this trial is to investigate the absolute bioavailability of BI 1265162 following administration of oral solution and inhaled (with and without charcoal) via Respimat.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 1265162 (T1); Drug: BI 1265162 (T2); Drug: BI 1265162 (R); Drug: BI 1265162 (T3)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Absolute Bioavailability of BI 1265162 Following Oral and Inhaled Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Three-period, Three-sequence Crossover Study Followed by a Fixed Treatment)
• Actual Study Start Date: Apr 23, 2019
• Actual Primary Completion Date: Dec 6, 2019
• Actual Study Completion Date: Dec 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T1-T2-R-T3	Drug: BI 1265162 (T1); oral solution; Drug: BI 1265162 (T2); Solution for inhalation; Drug: BI 1265162 (R); concentrate for i.v. solution; Drug: BI 1265162 (T3); Solution for inhalation
Experimental: R-T1-T2-T3	Drug: BI 1265162 (T1); oral solution; Drug: BI 1265162 (T2); Solution for inhalation; Drug: BI 1265162 (R); concentrate for i.v. solution; Drug: BI 1265162 (T3); Solution for inhalation
Experimental: T2-R-T1-T3	Drug: BI 1265162 (T1); oral solution; Drug: BI 1265162 (T2); Solution for inhalation; Drug: BI 1265162 (R); concentrate for i.v. solution; Drug: BI 1265162 (T3); Solution for inhalation

Outcome Measures

Primary Outcome Measures

1. Area Under the Concentration-time Curve of BI 1265162 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Dose-normalized, (AUC0-∞, Norm) [Up to 24 hours following administration of the trial drug, see detailed time frame in the endpoint description.]

   Area under the concentration-time curve of BI 1265162 in plasma over the time interval from 0 extrapolated to infinity, dose-normalized to 1 µg BI 1265162, (AUC0-∞, norm). Time frame for treatment T1: Within 3 hours before and 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours following administration of the trial drug. Time frame for treatment T2 and T3: Within 3 hours before and 2, 5, 10, 15 and 40 minutes, 1, 2, 4, 8, 10, 12 and 24 hours following administration of the trial drug. Time frame for treatment R: Within 3 hours (h) before and 5, 30 and 59 minutes (min), 1 h 5 min, 1 h 10 min, 1 h 20 min, 1 h 40 min, 2, 2 h 30 min, 3, 3 h 30 min, 4, 5, 7, 9, 11, 13 and 24 hours following administration of the trial drug.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory

• Age of 18 to 50 years (inclusive)

• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)

• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

• Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator

• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm

• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

• Any evidence of a concomitant disease assessed as clinically relevant by the investigator

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

• History of relevant orthostatic hypotension, fainting spells, or blackouts

• Chronic or relevant acute infections

• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)

• Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)

• Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered

• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)

• Inability to refrain from smoking on specified trial days

• Alcohol abuse (consumption of more than 30 g per day)

• Drug abuse or positive drug screening

• Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial

• Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial

• Inability to comply with the dietary regimen of the trial site

• A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening

• A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)

• Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study

• The subject has a diagnosis history of pulmonary hyperreactivity

• A history of chronic kidney disease

• Cannot use Respimat® appropriately

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Humanpharmakologisches Zentrum Biberach	Biberach		Germany	88397

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Aug 20, 2019
• Statistical Analysis Plan - Dec 13, 2019

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03907280
• Other Study ID Numbers: 1399-0014; 2018-002689-38
• First Posted: Apr 8, 2019
• Last Update Posted: Jul 6, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Recruitment Details	The trial was performed as a randomized, open-label, 3-way crossover trial followed by a fixed treatment in healthy male subjects in order to compare BI 1265162 given as oral solution (T1) and BI 1265162 inhaled via Respimat® with activated charcoal (T2) and without activated charcoal (fixed treatment, T3) compared with BI 1265162 given intravenously (R).
Pre-assignment Detail	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.

Arm/Group Title	(T1-T2-R-T3) Treatment Sequence	(R-T1-T2-T3) Treatment Sequence	(T2-R-T1-T3) Treatment Sequence
Arm/Group Description	In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.	In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.	In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.
Period Title: Treatment Period 1 + Washout Period 1
STARTED	4	4	4
Treated With BI 1265162	4	4	4
COMPLETED	4	4	4
NOT COMPLETED	0	0	0
Period Title: Treatment Period 1 + Washout Period 1
STARTED	4	4	4
Treated With BI 1265162	4	4	4
COMPLETED	4	4	4
NOT COMPLETED	0	0	0
Period Title: Treatment Period 1 + Washout Period 1
STARTED	4	4	4
Treated With BI 1265162	4	3	4
COMPLETED	4	3	4
NOT COMPLETED	0	1	0
Period Title: Treatment Period 1 + Washout Period 1
STARTED	4	4	4
Treated With BI 1265162	4	4	4
COMPLETED	4	4	4
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	(T1-T2-R-T3) Treatment Sequence	(R-T1-T2-T3) Treatment Sequence	(T2-R-T1-T3) Treatment Sequence	Total
Arm/Group Description	In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.	In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.	In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.	Total of all reporting groups
Overall Participants	4	4	4	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.3 (6.9)	41.3 (7.9)	39.8 (10.2)	36.8 (9.5)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	4 100%	4 100%	4 100%	12 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	4 100%	4 100%	4 100%	12 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	4 100%	4 100%	4 100%	12 100%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Area Under the Concentration-time Curve of BI 1265162 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Dose-normalized, (AUC0-∞, Norm)
Description	Area under the concentration-time curve of BI 1265162 in plasma over the time interval from 0 extrapolated to infinity, dose-normalized to 1 µg BI 1265162, (AUC0-∞, norm). Time frame for treatment T1: Within 3 hours before and 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours following administration of the trial drug. Time frame for treatment T2 and T3: Within 3 hours before and 2, 5, 10, 15 and 40 minutes, 1, 2, 4, 8, 10, 12 and 24 hours following administration of the trial drug. Time frame for treatment R: Within 3 hours (h) before and 5, 30 and 59 minutes (min), 1 h 5 min, 1 h 10 min, 1 h 20 min, 1 h 40 min, 2, 2 h 30 min, 3, 3 h 30 min, 4, 5, 7, 9, 11, 13 and 24 hours following administration of the trial drug.
Time Frame	Up to 24 hours following administration of the trial drug, see detailed time frame in the endpoint description.

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) parameter analysis set (PKS): All participants who were randomized and treated with at least 1 dose of any trial drug and who provided at least 1 PK endpoint being defined as primary or further and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Arm/Group Title	BI 1265162 as Infusion (R)	BI 1265162 as Oral Solution (T1)	BI 1265162 for Inhalation With Activated Charcoal (T2)	BI 1265162 for Inhalation Without Activated Charcoal (T3)
Arm/Group Description	50 microgram (μg) of BI 1265162 concentrate for infusion (2 milliliter (mL) of 25 μg/mL) administered intravenously over 1 hour after an overnight fast of at least 8 hours (Reference treatment, R).	1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (Test treatment 1, T1).	200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 hours in combination with activated charcoal (Test treatment 2, T2).	200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 hours without activated charcoal (Fixed treatment, Test treatment 3, T3).
Measure Participants	12	12	11	12
Geometric Least Squares Mean (Standard Error) [((hour * millimole) / liter) / kilogram]	44.63 (NA)	0.22 (NA)	17.97 (NA)	17.96 (NA)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BI 1265162 as Infusion (R), BI 1265162 as Oral Solution (T1)
	Comments	Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').
	Type of Statistical Test	Other
	Comments	Absolute bioavailability comparison
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the geometric means (T1/R) [%]
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 90%; 0.39 to 0.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.15
	Estimation Comments	The standard error of the mean is actually the geometric standard error.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	BI 1265162 as Infusion (R), BI 1265162 for Inhalation With Activated Charcoal (T2)
	Comments	Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').
	Type of Statistical Test	Other
	Comments	Absolute bioavailability comparison
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the geometric means (T2/R) [%]
	Estimated Value	40.26
	Confidence Interval	(2-Sided) 90%; 31.68 to 51.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.15
	Estimation Comments	The standard error of the mean is actually the geometric standard error.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	BI 1265162 as Infusion (R), BI 1265162 for Inhalation Without Activated Charcoal (T3)
	Comments	Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').
	Type of Statistical Test	Other
	Comments	Absolute bioavailability comparison
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the geometric means (T3/R) [%]
	Estimated Value	40.24
	Confidence Interval	(2-Sided) 90%; 31.86 to 50.83
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.15
	Estimation Comments

Adverse Events

Time Frame	For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Adverse Event Reporting Description	Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
Arm/Group Title	BI 1265162 as Infusion (R)		BI 1265162 as Oral Solution (T1)		BI 1265162 for Inhalation With Activated Charcoal (T2)		BI 1265162 for Inhalation Without Activated Charcoal (T3)
Arm/Group Description	50 microgram (μg) of BI 1265162 concentrate for infusion (2 milliliter (mL) of 25 μg/mL) administered intravenously over 1 hour after an overnight fast of at least 8 hours (Reference treatment, R).		1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (Test treatment 1, T1).		200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 hours in combination with activated charcoal (Test treatment 2, T2).		200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 hours without activated charcoal (Fixed treatment, Test treatment 3, T3).
All Cause Mortality
	BI 1265162 as Infusion (R)		BI 1265162 as Oral Solution (T1)		BI 1265162 for Inhalation With Activated Charcoal (T2)		BI 1265162 for Inhalation Without Activated Charcoal (T3)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/11 (0%)		0/12 (0%)
Serious Adverse Events
	BI 1265162 as Infusion (R)		BI 1265162 as Oral Solution (T1)		BI 1265162 for Inhalation With Activated Charcoal (T2)		BI 1265162 for Inhalation Without Activated Charcoal (T3)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		1/12 (8.3%)		0/11 (0%)		0/12 (0%)
Ear and labyrinth disorders
Vestibular disorder	0/12 (0%)		1/12 (8.3%)		0/11 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	BI 1265162 as Infusion (R)		BI 1265162 as Oral Solution (T1)		BI 1265162 for Inhalation With Activated Charcoal (T2)		BI 1265162 for Inhalation Without Activated Charcoal (T3)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		2/12 (16.7%)		0/11 (0%)		1/12 (8.3%)
Gastrointestinal disorders
Vomiting	0/12 (0%)		1/12 (8.3%)		0/11 (0%)		0/12 (0%)
Nervous system disorders
Headache	1/12 (8.3%)		1/12 (8.3%)		0/11 (0%)		1/12 (8.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.