Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01965431
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 15.9

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined with faldaprevir on cardiac safety parameters in healthy subjects

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 207127; Drug: BI 207127 placebo; Drug: Faldaprevir placebo; Drug: Faldaprevir; Drug: Moxifloxacin (Avalox®)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Female and Male Subjects. Randomised, Placebo Controlled, Single-blind, Three-period Crossover Phase-I-study With Moxifloxacin as Positive Control
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 207127 + Faldaprevir Tablets/capsules	Drug: BI 207127; Medium dose oral administration; Drug: Faldaprevir; Medium dose oral administration
Active Comparator: Moxifloxacin (Avalox®) Tablets	Drug: Moxifloxacin (Avalox®)
Experimental: BI 207127 placebo + Faldaprevir placebo Tablets/capsules	Drug: BI 207127 placebo; Drug: Faldaprevir placebo

Outcome Measures

Primary Outcome Measures

1. Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy [20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1]

   Maximum mean placebo-corrected QT interval corrected for heart rate according to a parabolic population model (QTcN) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values.

Secondary Outcome Measures

1. Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment [20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h and 6h after drug adminstration on day 1]

   Maximum mean placebo-corrected QTcN change from baseline between 1 to 6 hours on Day 1 for the Moxifloxacin treatment is estimated. QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values.

2. Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy [20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1]

   Maximum mean placebo-corrected heart rate (HR) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.

3. Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy [20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1]

   Minimum mean placebo-corrected HR (heart rate) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• Healthy male and female subjects

• Subjects must be able to understand and comply with study requirements

• Age =18 and =55 years

• BMI range: =18.5 and =29.9 kg/m2

Exclusion criteria:

• any relevant deviation from healthy conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1241.40.1 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: NCT01965431
• Other Study ID Numbers: 1241.40; 2013-002741-11
• First Posted: Oct 18, 2013
• Last Update Posted: Apr 14, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Moxifloxacin

Study Results

Participant Flow

Pre-assignment Detail	After an initial screening (Visit 1) within Day -23 and Day -3 prior of the first treatment period, subjects meeting all inclusion and none of the exclusion criteria participated in Visits 2 to 5.

Arm/Group Title	T/R1/R2	T/R2/R1	R1/T/R2	R1/R2/T	R2/T/R1	R2/R1/T
Arm/Group Description	Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) twice daily (bid) were administered on day -2 and day -1 and 600 mg once daily (qd) on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg once daily (qd) on day -1 and day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2) : Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.	Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.	Patients were treated with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2):Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.	Patients were treated in the morning with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.	Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered on as single dose on day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.	Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
Period Title: Overall Study
STARTED	8	8	8	8	8	8
COMPLETED	2	2	2	2	2	2
NOT COMPLETED	6	6	6	6	6	6

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	This study is randomised, single-blind, 3-period crossover having 3 treatments, BI 207127 and Faldaprevir for 3 days (Days -2 to 1), placebo to BI 207127 plus placebo to Faldaprevir for 3 days (Days -2 to 1) and Moxifloxacin 400 mg as single dose (Day 1).
Overall Participants	48
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	37.5 (8.8)
Sex: Female, Male (Count of Participants)
Female	24 50%
Male	24 50%

Outcome Measures

1. Primary Outcome

Title	Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy
Description	Maximum mean placebo-corrected QT interval corrected for heart rate according to a parabolic population model (QTcN) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values.
Time Frame	20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1

Outcome Measure Data

Analysis Population Description

Electrocardiogram (ECG) analysis set (ECGS): all subjects in the treated set who had at least 1 baseline and post-baseline assessment for at least 1 ECG endpoint.

Arm/Group Title	BI 207127+ Faldaprevir	Placebo to BI 207127 + Placebo to Faldaprevir
Arm/Group Description	Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.	Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
Measure Participants	31	32
Mean (Standard Error) [ms]	-0.47 (1.65)	-8.37 (1.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BI 207127+ Faldaprevir, Placebo to BI 207127 + Placebo to Faldaprevir
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin is the maximum acceptable extent of statistical and clinical noninferiority of an experimental treatment. Non-inferiority margin for this trial is 10ms.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	7.90
	Confidence Interval	(2-Sided) 90%; 5.37 to 10.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.52
	Estimation Comments	Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' & 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.

2. Secondary Outcome

Title	Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment
Description	Maximum mean placebo-corrected QTcN change from baseline between 1 to 6 hours on Day 1 for the Moxifloxacin treatment is estimated. QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values.
Time Frame	20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h and 6h after drug adminstration on day 1

Outcome Measure Data

Analysis Population Description

ECG analysis set (ECGS)

Arm/Group Title	Moxifloxacin	Placebo to BI 207127 + Placebo to Faldaprevir
Arm/Group Description	Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day 1 with 240 mL of water.	Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
Measure Participants	31	32
Mean (Standard Error) [ms]	14.95 (1.84)	2.25 (1.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BI 207127+ Faldaprevir, Placebo to BI 207127 + Placebo to Faldaprevir
	Comments	No formal hypothesis testing was done.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	12.70
	Confidence Interval	(2-Sided) 90%; 9.32 to 16.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.02
	Estimation Comments	Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' & 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.

3. Secondary Outcome

Title	Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy
Description	Maximum mean placebo-corrected heart rate (HR) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.
Time Frame	20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1

Outcome Measure Data

Analysis Population Description

ECG analysis set (ECGS)

Arm/Group Title	BI 207127 + Faldaprevir	Placebo to BI 207127) + Placebo to Faldaprevir
Arm/Group Description	Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.	Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
Measure Participants	31	32
Mean (Standard Error) [bpm]	-3.47 (0.88)	-3.64 (0.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BI 207127+ Faldaprevir, Placebo to BI 207127 + Placebo to Faldaprevir
	Comments	No formal hypothesis testing was done.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 90%; -1.38 to 1.73
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.94
	Estimation Comments	Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' & 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.

4. Secondary Outcome

Title	Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy
Description	Minimum mean placebo-corrected HR (heart rate) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.
Time Frame	20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1

Outcome Measure Data

Analysis Population Description

ECG analysis set (ECGS)

Arm/Group Title	BI 207127 + Faldaprevir	Placebo to BI 207127 + Placebo to Faldaprevir
Arm/Group Description	Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.	Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
Measure Participants	31	32
Mean (Standard Error) [bpm]	-0.68 (0.88)	3.74 (0.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BI 207127+ Faldaprevir, Placebo to BI 207127 + Placebo to Faldaprevir
	Comments	No formal hypothesis testing was done.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.42
	Confidence Interval	(2-Sided) 90%; -5.98 to -2.87
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.94
	Estimation Comments	Minimum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' & 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.

Adverse Events

Time Frame	From the first drug administration until 8 days after the last drug administration, upto 9 days for Moxifloxacin and upto 11 days for BI 207127 + Faldaprevir and Placebo.
Arm/Group Title	BI 207127 + Faldaprevir		Moxifloxacin		Placebo (BI 207127) + Placebo (Faldaprevir)
Arm/Group Description	Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water.		Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day1 with 240 mL of water.		Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water.
All Cause Mortality
	BI 207127 + Faldaprevir		Moxifloxacin		Placebo (BI 207127) + Placebo (Faldaprevir)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	BI 207127 + Faldaprevir		Moxifloxacin		Placebo (BI 207127) + Placebo (Faldaprevir)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/31 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	BI 207127 + Faldaprevir		Moxifloxacin		Placebo (BI 207127) + Placebo (Faldaprevir)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/32 (53.1%)		4/31 (12.9%)		7/32 (21.9%)
Gastrointestinal disorders
Abdominal distension	3/32 (9.4%)		0/31 (0%)		1/32 (3.1%)
Abdominal pain	2/32 (6.3%)		0/31 (0%)		0/32 (0%)
Diarrhoea	5/32 (15.6%)		1/31 (3.2%)		1/32 (3.1%)
Nausea	5/32 (15.6%)		1/31 (3.2%)		0/32 (0%)
General disorders
Fatigue	1/32 (3.1%)		1/31 (3.2%)		2/32 (6.3%)
Infections and infestations
Nasopharyngitis	1/32 (3.1%)		1/31 (3.2%)		3/32 (9.4%)
Nervous system disorders
Headache	10/32 (31.3%)		0/31 (0%)		5/32 (15.6%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion	2/32 (6.3%)		0/31 (0%)		0/32 (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.