To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02093819
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 29.9

Study Details

Study Description

Brief Summary

To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Placebo to BI 416970; Drug: BI 416970	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 416970 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, Investigation of Relative Bioavailability of BI 416970 (Open-label, Randomised, Three-way Cross-over) and Assessment of Safety and Exposure of BI 416970 in CYP2C9 Genotyped Volunteers (Open-label, Single-dose)
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 416970 single rising dose part single rising dose given as tablet	Drug: Placebo to BI 416970; single rising doses; Drug: BI 416970; single rising doses

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With Drug-related Adverse Events [AEs were recorded throughout the trial]

   Percentage of subjects with drug-related adverse events

Secondary Outcome Measures

1. Cmax (Maximum Measured Concentration of the Analyte in Plasma) [2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration]

   Cmax (maximum measured concentration of the analyte in plasma)

2. AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) [2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration]

   AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Eligibility Criteria

Criteria

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

Inclusion criteria:

• Healthy males according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory

• Age 18 to 50 years (incl.)

• Body Mass Index 18.5 to 29.9 kg/m2 (incl.)

• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

• Known genotype of CYP2C9 isoenzyme

Exclusion criteria:

• Any finding in the medical examination (including Blood Pressure, Pulse Rate or Electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator

• Repeated measurement of systolic blood pressure outside of ranges 90-140 mmHg, diastolic blood pressure outside of ranges 50-90 mmHg, or pulse rate outside the range of 50 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 judged as clinically relevant by the investigator

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

• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication

• Diseases of the central nervous system (such as epilepsy), other peripheral neurological disorders or psychiatric disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1345.1.1 Boehringer Ingelheim Investigational Site	Biberach		Germany

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02093819
• Other Study ID Numbers: 1345.1; 2013-003560-31
• First Posted: Mar 21, 2014
• Last Update Posted: Mar 22, 2016
• Last Verified: Feb 1, 2016

Study Results

Participant Flow

Recruitment Details	The study was conducted in eight groups.

Arm/Group Title	Placebo	BI 416970 10mg	BI 416970 25mg	BI 416970 50mg	BI 416970 100mg	BI 416970 200mg	BI 416970 400mg	BI 416970 600mg
Arm/Group Description	The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
Period Title: Overall Study
STARTED	15	6	10	6	6	6	5	6
COMPLETED	15	6	10	6	6	6	5	6
NOT COMPLETED	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo	BI 416970 10mg	BI 416970 25mg	BI 416970 50mg	BI 416970 100mg	BI 416970 200mg	BI 416970 400mg	BI 416970 600mg	Total
Arm/Group Description	The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	Total of all reporting groups
Overall Participants	15	6	10	6	6	6	5	6	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.6 (9.2)	35.7 (7.9)	38.9 (8.7)	34.2 (10.0)	31.0 (4.6)	31.2 (12.7)	34.0 (9.5)	35.3 (10.9)	34.5 (9.1)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	15 100%	6 100%	10 100%	6 100%	6 100%	6 100%	5 100%	6 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Drug-related Adverse Events
Description	Percentage of subjects with drug-related adverse events
Time Frame	AEs were recorded throughout the trial

Outcome Measure Data

Analysis Population Description

The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.

Arm/Group Title	Placebo	BI 416970 10mg	BI 416970 25mg	BI 416970 50mg	BI 416970 100mg	BI 416970 200mg	BI 416970 400mg	BI 416970 600mg
Arm/Group Description	The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h	The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
Measure Participants	15	6	10	6	6	6	5	6
Number [percentage of participants]	6.7 44.7%	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%	20.0 400%	0.0 0%

2. Secondary Outcome

Title	Cmax (Maximum Measured Concentration of the Analyte in Plasma)
Description	Cmax (maximum measured concentration of the analyte in plasma)
Time Frame	2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration

Outcome Measure Data

Analysis Population Description

The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.

Arm/Group Title	BI 416970 10mg	BI 416970 25mg	BI 416970 50mg	BI 416970 100mg	BI 416970 200mg	BI 416970 400mg	BI 416970 600mg
Arm/Group Description	The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
Measure Participants	6	10	6	6	6	5	5
Geometric Mean (Geometric Coefficient of Variation) [nmol/L]	15.2 (66.3)	44.0 (80.5)	154 (69.6)	250 (37.2)	482 (40.3)	1060 (70.4)	1610 (50.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, BI 416970 10mg, BI 416970 25mg, BI 416970 50mg, BI 416970 100mg, BI 416970 200mg, BI 416970 400mg
	Comments	A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.1313
	Confidence Interval	(2-Sided) 90%; 1.0249 to 1.2376
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0633
	Estimation Comments	Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	BI 416970 25mg, BI 416970 50mg, BI 416970 100mg, BI 416970 200mg, BI 416970 400mg
	Comments	A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.9568
	Confidence Interval	(2-Sided) 90%; 0.7830 to 1.1307
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.1019
	Estimation Comments	Evaluation of dose proportionality - dose groups 50mg to 600mg. Number of subjects included in the analysis=28.

3. Secondary Outcome

Title	AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Description	AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame	2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration

Outcome Measure Data

Analysis Population Description

The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.

Arm/Group Title	BI 416970 10mg	BI 416970 25mg	BI 416970 50mg	BI 416970 100mg	BI 416970 200mg	BI 416970 400mg	BI 416970 600mg
Arm/Group Description	The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
Measure Participants	6	10	6	6	6	5	5
Geometric Mean (Geometric Coefficient of Variation) [nmol*h/L]	72.8 (41.5)	195 (49.8)	566 (54.0)	992 (36.1)	1770 (34.6)	3970 (61.3)	6150 (23.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, BI 416970 10mg, BI 416970 25mg, BI 416970 50mg, BI 416970 100mg, BI 416970 200mg, BI 416970 400mg
	Comments	A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.0732
	Confidence Interval	(2-Sided) 90%; 0.9946 to 1.1518
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0468
	Estimation Comments	Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	BI 416970 25mg, BI 416970 50mg, BI 416970 100mg, BI 416970 200mg, BI 416970 400mg
	Comments	A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.9603
	Confidence Interval	(2-Sided) 90%; 0.8174 to 1.1032
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0838
	Estimation Comments	Evaluation of dose proportionality - dose groups 50 mg to 600 mg. Number of subjects included in the analysis 28.

Adverse Events

Time Frame	From the first intake of trial medication until the end of trial examination, up to 14 days.
Arm/Group Title	Placebo		BI 416970 10 mg		BI 416970 25 mg		BI 416970 50 mg		BI 416970 100 mg		BI 416970 200 mg		BI 416970 400 mg		BI 416970 600 mg		Total BI 416970 Treatment		Total Treatment
Arm/Group Description	The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.		The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.		The medication was administered as a single oral dose (dose = 25 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.		The medication was administered as a single oral dose (dose = 50 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.		The medication was administered as a single oral dose (dose = 100 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.		The medication was administered as a single oral dose (dose = 200 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.		The medication was administered as a single oral dose (dose = 400 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.		The medication was administered as a single oral dose (dose = 600 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.		All patients affected by AEs during administration of BI 416970 medication .		All patients affected by AEs during entire treatment period.
All Cause Mortality
	Placebo		BI 416970 10 mg		BI 416970 25 mg		BI 416970 50 mg		BI 416970 100 mg		BI 416970 200 mg		BI 416970 400 mg		BI 416970 600 mg		Total BI 416970 Treatment		Total Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		BI 416970 10 mg		BI 416970 25 mg		BI 416970 50 mg		BI 416970 100 mg		BI 416970 200 mg		BI 416970 400 mg		BI 416970 600 mg		Total BI 416970 Treatment		Total Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/6 (0%)		0/10 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/45 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		BI 416970 10 mg		BI 416970 25 mg		BI 416970 50 mg		BI 416970 100 mg		BI 416970 200 mg		BI 416970 400 mg		BI 416970 600 mg		Total BI 416970 Treatment		Total Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/15 (6.7%)		1/6 (16.7%)		3/10 (30%)		1/6 (16.7%)		0/6 (0%)		2/6 (33.3%)		2/5 (40%)		1/6 (16.7%)		10/45 (22.2%)		11/60 (18.3%)
Gastrointestinal disorders
Diarrhoea	0/15 (0%)		0/6 (0%)		0/10 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		1/45 (2.2%)		1/60 (1.7%)
Nausea	0/15 (0%)		0/6 (0%)		0/10 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		1/45 (2.2%)		1/60 (1.7%)
Vomiting	0/15 (0%)		0/6 (0%)		0/10 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		1/6 (16.7%)		2/45 (4.4%)		2/60 (3.3%)
Infections and infestations
Gastrointestinal infection	0/15 (0%)		0/6 (0%)		0/10 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/45 (2.2%)		1/60 (1.7%)
Nasopharyngitis	0/15 (0%)		1/6 (16.7%)		1/10 (10%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		2/45 (4.4%)		2/60 (3.3%)
Musculoskeletal and connective tissue disorders
Back pain	0/15 (0%)		0/6 (0%)		0/10 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		1/45 (2.2%)		1/60 (1.7%)
Nervous system disorders
Headache	0/15 (0%)		0/6 (0%)		1/10 (10%)		1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		1/5 (20%)		0/6 (0%)		4/45 (8.9%)		4/60 (6.7%)
Paraesthesia	1/15 (6.7%)		0/6 (0%)		0/10 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/45 (0%)		1/60 (1.7%)
Respiratory, thoracic and mediastinal disorders
Cough	0/15 (0%)		0/6 (0%)		1/10 (10%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/45 (2.2%)		1/60 (1.7%)

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.