Safety Tolerability and Pharmacokinetic of BI 411034

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01581684
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 9
• Actual Duration (Months): 4
• Patients Per Site Per Month: 15.5

Study Details

Study Description

Brief Summary

The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.

The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).

Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 411034; Drug: Placebo; Drug: BI 411034; Drug: BI 411034; Drug: BI 411034; Drug: BI 411034; Drug: BI 411034; Drug: BI 411034; Drug: BI 411034	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 411034 (PIB) in Healthy Male Volunteers (Randomised, Single-blind, Placebocontrolled Within Dose Groups, Phase I Study)
• Actual Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 411034 low dose - group 1 Solution for oral administration	Drug: BI 411034; Low dose solution for oral administration
Experimental: BI 411034 low dose - group 2 Solution for oral administration	Drug: BI 411034; Low dose solution for oral administration
Experimental: BI 411034 medium dose - group 3 Solution for oral administration	Drug: BI 411034; Medium dose solution for oral administration
Experimental: BI 411034 medium dose - group 4 Solution for oral administration	Drug: BI 411034; Medium dose solution for oral administration
Experimental: BI 411034 medium dose - group 5 Solution for oral administration	Drug: BI 411034; Medium dose solution for oral administration
Experimental: BI 411034 high dose - group 6 Solution for oral administration	Drug: BI 411034; High dose solution for oral administration
Experimental: BI 411034 high dose - group 7 Solution for oral administration	Drug: BI 411034; High dose solution for oral administration
Experimental: BI 411034 high dose - group 8 Solution for oral administration	Drug: BI 411034; High dose solution for oral administration
Placebo Comparator: Placebo Solution for oral administration	Drug: Placebo; Solution for oral administration

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Drug Related AEs [From drug administration until end of trial examination, up to 13 days]

   Number of participants with drug related adverse events (AEs)

2. Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests [From drug administration until end of trial examination, up to 13 days]

   Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).

Secondary Outcome Measures

1. Maximum Measured Concentration (Cmax ) [2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration]

   Maximum measured concentration of the analyte (BI 411034) in plasma

2. Time to Maximum Measured Concentration (Tmax) [2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration]

   Time from dosing to maximum measured concentration

3. Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity) [2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration]

   Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity

4. Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4) [2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration]

   Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h.

Eligibility Criteria

Criteria

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

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1308.1.1 Boehringer Ingelheim Investigational Site	Ingelheim		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: NCT01581684
• Other Study ID Numbers: 1308.1; 2011-004840-23
• First Posted: Apr 20, 2012
• Last Update Posted: Aug 15, 2017
• Last Verified: Jul 1, 2017

Study Results

Participant Flow

Arm/Group Title	Placebo EM	2mg EM	8mg EM	20mg EM	40mg EM	80mg EM	150mg EM	250mg EM	Placebo PM	20/60mg PM
Arm/Group Description	A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)	Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)	Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
Period Title: Overall Study
STARTED	14	6	6	6	6	6	6	6	1	5
COMPLETED	14	6	6	6	6	6	6	6	0	5
NOT COMPLETED	0	0	0	0	0	0	0	0	1	0

Baseline Characteristics

Arm/Group Title	Placebo EM	2mg EM	8mg EM	20mg EM	40mg EM	80mg EM	150mg EM	250mg EM	Placebo PM	20/60mg PM	Total
Arm/Group Description	A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)	Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)	Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers	Total of all reporting groups
Overall Participants	14	6	6	6	6	6	6	6	1	5	62
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.4 (6.3)	35.5 (9.9)	39.8 (4.3)	38.8 (8.7)	38.3 (8.2)	39.5 (3.1)	32.7 (5.4)	43.8 (6.7)	31.0 (NA)	42.4 (8.6)	38.6 (7.1)
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%	0 0%	0 0%
Male	14 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	1 100%	5 100%	62 100%

Outcome Measures

1. Secondary Outcome

Title	Maximum Measured Concentration (Cmax )
Description	Maximum measured concentration of the analyte (BI 411034) in plasma
Time Frame	2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration

Outcome Measure Data

Analysis Population Description

PK analysis set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment and who provided at least one observation for at least one pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK

Arm/Group Title	2mg EM	8mg EM	20mg EM	40mg EM	80mg EM	150mg EM	250mg EM	20mg PM	60mg PM
Arm/Group Description	Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Measure Participants	6	6	6	6	6	6	6	5	5
Geometric Mean (Geometric Coefficient of Variation) [nmol/L]	61.7 (34.0)	236 (55.9)	566 (22.0)	629 (53.9)	2630 (38.8)	4610 (51.4)	6600 (15.3)	935 (17.1)	2890 (36.5)

2. Secondary Outcome

Title	Time to Maximum Measured Concentration (Tmax)
Description	Time from dosing to maximum measured concentration
Time Frame	2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration

Outcome Measure Data

Analysis Population Description

PK analysis set

Arm/Group Title	2mg EM	8mg EM	20mg EM	40mg EM	80mg EM	150mg EM	250mg EM	20mg PM	60mg PM
Arm/Group Description	Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Measure Participants	6	6	6	6	6	6	6	5	5
Median (Full Range) [h]	0.5	0.63	0.63	1.00	0.62	0.62	0.63	0.75	0.50

3. Secondary Outcome

Title	Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)
Description	Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity
Time Frame	2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration

Outcome Measure Data

Analysis Population Description

PK analysis set

Arm/Group Title	2mg EM	8mg EM	20mg EM	40mg EM	80mg EM	150mg EM	250mg EM	20mg PM	60mg PM
Arm/Group Description	Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Measure Participants	6	6	6	6	6	6	6	5	5
Geometric Mean (Geometric Coefficient of Variation) [nmol*h/L]	134 (54.3)	729 (96.4)	1410 (18.1)	1900 (66.2)	6140 (53.6)	13300 (70.6)	19700 (47.7)	6240 (14.8)	18500 (13.1)

4. Secondary Outcome

Title	Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)
Description	Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h.
Time Frame	2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration

Outcome Measure Data

Analysis Population Description

PK analysis set

Arm/Group Title	2mg EM	8mg EM	20mg EM	40mg EM	80mg EM	150mg EM	250mg EM	20mg PM	60mg PM
Arm/Group Description	Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Measure Participants	6	6	6	6	6	6	6	5	5
Geometric Mean (Geometric Coefficient of Variation) [nmol]	77.6 (50.3)	290 (22.1)	530 (38.2)	860 (34.1)	2070 (38.8)	3390 (44.6)	4520 (25.9)	1220 (30.3)	3080 (22.1)

5. Primary Outcome

Title	Number of Participants With Drug Related AEs
Description	Number of participants with drug related adverse events (AEs)
Time Frame	From drug administration until end of trial examination, up to 13 days

Outcome Measure Data

Analysis Population Description

Treated set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment

Arm/Group Title	Placebo EM	2mg EM	8mg EM	20mg EM	40mg EM	80mg EM	150mg EM	250mg EM	Placebo PM	20mg PM	60mg PM
Arm/Group Description	A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)	Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)	Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Measure Participants	14	6	6	6	6	6	6	6	1	5	5
Number [participants]	1 7.1%	0 0%	0 0%	1 16.7%	1 16.7%	1 16.7%	2 33.3%	3 50%	0 0%	0 0%	2 3.2%

6. Primary Outcome

Title	Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests
Description	Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).
Time Frame	From drug administration until end of trial examination, up to 13 days

Outcome Measure Data

Analysis Population Description

Treated set

Arm/Group Title	Placebo EM	2mg EM	8mg EM	20mg EM	40mg EM	80mg EM	150mg EM	250mg EM	Placebo PM	20mg PM	60mg PM
Arm/Group Description	A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)	Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)	Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Measure Participants	14	6	6	6	6	6	6	6	1	5	5
Number [participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Adverse Events

Time Frame	From drug administration until end of trial examination, up to 13 days
Arm/Group Title	Placebo EM		2mg EM		8mg EM		20mg EM		40mg EM		80mg EM		150mg EM		250mg EM		Placebo PM		20mg PM		60mg PM
Arm/Group Description	A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)		Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers		Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers		Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers		Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers		Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers		Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers		Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers		A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)		Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers		Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
All Cause Mortality
	Placebo EM		2mg EM		8mg EM		20mg EM		40mg EM		80mg EM		150mg EM		250mg EM		Placebo PM		20mg PM		60mg PM
	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	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo EM		2mg EM		8mg EM		20mg EM		40mg EM		80mg EM		150mg EM		250mg EM		Placebo PM		20mg PM		60mg PM
	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	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/1 (0%)		0/5 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Placebo EM		2mg EM		8mg EM		20mg EM		40mg EM		80mg EM		150mg EM		250mg EM		Placebo PM		20mg PM		60mg PM
	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	Affected / at Risk (%)	# Events
Total	3/14 (21.4%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		1/6 (16.7%)		2/6 (33.3%)		2/6 (33.3%)		3/6 (50%)		1/1 (100%)		0/5 (0%)		3/5 (60%)
Eye disorders
Chromatopsia	0/14 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/1 (0%)		0/5 (0%)		0/5 (0%)
Photophobia	0/14 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/1 (0%)		0/5 (0%)		1/5 (20%)
Gastrointestinal disorders
Nausea	0/14 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/1 (0%)		0/5 (0%)		0/5 (0%)
General disorders
Feeling drunk	1/14 (7.1%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/1 (0%)		0/5 (0%)		0/5 (0%)
Infections and infestations
Nasopharyngitis	0/14 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/1 (0%)		0/5 (0%)		0/5 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/14 (7.1%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/1 (0%)		0/5 (0%)		1/5 (20%)
Nervous system disorders
Headache	0/14 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		2/6 (33.3%)		2/6 (33.3%)		0/6 (0%)		1/1 (100%)		0/5 (0%)		1/5 (20%)
Psychiatric disorders
Euphoric mood	0/14 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/1 (0%)		0/5 (0%)		0/5 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/14 (7.1%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/1 (0%)		0/5 (0%)		0/5 (0%)

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.