A Study of Evacetrapib in Participants With Abnormal Cholesterol

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02168803
• Collaborator: (none)
• Enrollment: 101
• Locations: 3
• Arms: 4
• Duration (Months): 19
• Patients Per Site: 33.7
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The main purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given once a day for 12, 24, and 52 weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream. Information about any side effects that may occur will also be collected.

This study will also evaluate how the study drug reacts in the body when given once a day for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is complete. The relationship between study drug and the results from the how the study drug reacts in the body may be explored, if needed.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia	Drug: Evacetrapib	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1b Study to Characterize the Pharmacokinetics of Evacetrapib and Potential for Accumulation After Dosing for 12, 24, and 52 Weeks
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Evacetrapib: Single Dose Single oral dose of evacetrapib on Day 1	Drug: Evacetrapib; Administered orally; Other Names: LY2484595
Experimental: Evacetrapib: Multiple Dose 12 Weeks Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks	Drug: Evacetrapib; Administered orally; Other Names: LY2484595
Experimental: Evacetrapib: Multiple Dose 24 Weeks Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks	Drug: Evacetrapib; Administered orally; Other Names: LY2484595
Experimental: Evacetrapib: Multiple Dose 52 Weeks Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks	Drug: Evacetrapib; Administered orally; Other Names: LY2484595

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) [Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose]

2. PK Parameters of Evacetrapib: Maximum Concentration (Cmax) [Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose]

3. PK Parameters of Evacetrapib: Terminal Half-life [Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose]

Secondary Outcome Measures

1. PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level [Day -1, Day 8]

2. PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level [Day -1, Day 8]

3. PD Parameters of Evacetrapib: Total Cholesterol Level [Day -1, Day 8]

4. PD Parameters of Evacetrapib: Triglyceride Level [Day -1, Day 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:

• Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR

• Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR

• Hypercholesterolemia on stable statin therapy for at least 3 month

• Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

• Have known allergies or intolerance to evacetrapib, related compounds

• Have history of recurrent rashes or chronic skin conditions

• Have significant history of or current chronic, active inflammatory conditions

• Have history or current evidence of significant neurological disorder

• Have long-standing diabetes that is insulin requiring

• Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Inc	Daytona Beach	Florida	United States	32117
2	Covance	Dallas	Texas	United States	75247
3	Covance Clinical Research Inc	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02168803
• Other Study ID Numbers: 15340; I1V-MC-EIBM
• First Posted: Jun 20, 2014
• Last Update Posted: Oct 3, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by Eli Lilly and Company: abnormal cholesterol
• Additional relevant MeSH terms: Dyslipidemias; Evacetrapib

Study Results

Participant Flow

Pre-assignment Detail	Participants were enrolled into 3 parallel cohorts. Each participant received a single dose, after which PK was evaluated for 7 days, and then continued receiving once daily doses for 12, 24, or 52 weeks. After the last once-daily dose, PK was again evaluated in each participant until the concentration of evacetrapib was too low to be measurable.

Arm/Group Title	Evacetrapib: Multiple Dose 12 Weeks	Evacetrapib: Multiple Dose 24 Weeks	Evacetrapib: Multiple Dose 52 Weeks
Arm/Group Description	130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12 consecutive weeks.	130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 24 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
Period Title: Overall Study
STARTED	30	32	39
Received at Least 1 Dose of Study Drug	30	32	39
COMPLETED	28	29	33
NOT COMPLETED	2	3	6

Baseline Characteristics

Arm/Group Title	Evacetrapib: Multiple Dose 12 Weeks	Evacetrapib: Multiple Dose 24 Weeks	Evacetrapib: Multiple Dose 52 Weeks	Total
Arm/Group Description	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks	Total of all reporting groups
Overall Participants	30	32	39	101
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.2 (14.5)	51.1 (14.9)	56.4 (9.4)	53.8 (13.0)
Sex: Female, Male (Count of Participants)
Female	17 56.7%	18 56.3%	20 51.3%	55 54.5%
Male	13 43.3%	14 43.8%	19 48.7%	46 45.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 16.7%	2 6.3%	6 15.4%	13 12.9%
Not Hispanic or Latino	25 83.3%	30 93.8%	33 84.6%	88 87.1%
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%	1 3.1%	2 5.1%	3 3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	10 33.3%	8 25%	9 23.1%	27 26.7%
White	20 66.7%	23 71.9%	28 71.8%	71 70.3%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	30 100%	32 100%	39 100%	101 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast])
Time Frame	Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least 1 dose of study drug and had evaluable PK data.

Arm/Group Title	Evacetrapib: Single Dose, All Participants	Evacetrapib: Multiple Dose 12 Weeks	Evacetrapib: Multiple Dose 24 Weeks	Evacetrapib: Multiple Dose 52 Weeks
Arm/Group Description	A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
Measure Participants	101	27	30	29
Geometric Mean (Geometric Coefficient of Variation) [nanogram∙hour/mililliter (ng∙h/mL)]	14200 (28)	37400 (43)	36900 (39)	44400 (32)

2. Primary Outcome

Title	PK Parameters of Evacetrapib: Maximum Concentration (Cmax)
Time Frame	Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least 1 dose of study drug and had evaluable PK data.

Arm/Group Title	Evacetrapib: Single Dose, All Participants	Evacetrapib: Multiple Dose 12 Weeks	Evacetrapib: Multiple Dose 24 Weeks	Evacetrapib: Multiple Dose 52 Weeks
Arm/Group Description	A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
Measure Participants	101	27	30	29
Geometric Mean (Geometric Coefficient of Variation) [nanogram/milliliter (ng/mL)]	1020 (32)	1690 (41)	1770 (39)	1850 (28)

3. Primary Outcome

Title	PK Parameters of Evacetrapib: Terminal Half-life
Time Frame	Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose

Outcome Measure Data

Analysis Population Description

A single terminal half-life estimate was calculated from population PK estimates for apparent clearance and apparent volume of distribution across all participants, based on all available single dose data and multiple dose data.

Arm/Group Title	Evacetrapib: Single, Multiple Dose 12, 24, and 52 Weeks
Arm/Group Description	A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
Measure Participants	101
Number [Days]	52.5

4. Secondary Outcome

Title	PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level
Time Frame	Day -1, Day 8

Outcome Measure Data

Analysis Population Description

All enrolled participants in the single dose phase and had evaluable PD data.

Arm/Group Title	Evacetrapib: Multiple Dose 12 Weeks	Evacetrapib: Multiple Dose 24 Weeks	Evacetrapib: Multiple Dose 52 Weeks
Arm/Group Description	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
Measure Participants	30	32	39
Single-Dose Phase Day -1	1.538 (0.416)	1.562 (0.395)	1.670 (0.548)
Single-dose Phase Day 8	1.724 (0.493)	1.777 (0.443)	1.772 (0.552)

5. Secondary Outcome

Title	PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level
Time Frame	Day -1, Day 8

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least 1 dose of study drug and had evaluable PD data.

Arm/Group Title	Evacetrapib: Multiple Dose 12 Weeks	Evacetrapib: Multiple Dose 24 Weeks	Evacetrapib: Multiple Dose 52 Weeks
Arm/Group Description	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
Measure Participants	30	32	39
Single-Dose Phase Day -1	3.711 (0.958)	3.359 (0.835)	3.662 (1.039)
Single-Dose Phase Day 8	3.173 (0.872)	3.152 (0.928)	3.293 (1.058)

6. Secondary Outcome

Title	PD Parameters of Evacetrapib: Total Cholesterol Level
Time Frame	Day -1, Day 8

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least 1 dose of study drug and had evaluable PD data.

Arm/Group Title	Evacetrapib: Multiple Dose 12 Weeks	Evacetrapib: Multiple Dose 24 Weeks	Evacetrapib: Multiple Dose 52 Weeks
Arm/Group Description	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
Measure Participants	30	32	39
Single-Dose Phase Day -1	5.922 (1.244)	5.523 (0.736)	6.015 (1.099)
Single-Dose Phase Day 8	5.577 (1.224)	5.531 (0.931)	5.715 (1.179)

7. Secondary Outcome

Title	PD Parameters of Evacetrapib: Triglyceride Level
Time Frame	Day -1, Day 8

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least 1 dose of study drug and had evaluable PD data.

Arm/Group Title	Evacetrapib: Multiple Dose 12 Weeks	Evacetrapib: Multiple Dose 24 Weeks	Evacetrapib: Multiple Dose 52 Weeks
Arm/Group Description	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.	130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
Measure Participants	30	32	39
Single-Dose Phase Day -1	1.474 (0.849)	1.311 (0.815)	1.485 (0.631)
Single-Dose Phase Day 8	1.482 (1.016)	1.309 (0.871)	1.419 (0.681)

Adverse Events

Arm/Group Title	Evacetrapib: Single Dose, All Participants		Evacetrapib: Multiple Dose 12 Weeks		Evacetrapib: Multiple Dose 24 Weeks		Evacetrapib: Multiple Dose 52 Weeks
Arm/Group Description	A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.		130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.		130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.		130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
All Cause Mortality
	Evacetrapib: Single Dose, All Participants		Evacetrapib: Multiple Dose 12 Weeks		Evacetrapib: Multiple Dose 24 Weeks		Evacetrapib: Multiple Dose 52 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Evacetrapib: Single Dose, All Participants		Evacetrapib: Multiple Dose 12 Weeks		Evacetrapib: Multiple Dose 24 Weeks		Evacetrapib: Multiple Dose 52 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/101 (0%)		0/30 (0%)		0/32 (0%)		5/39 (12.8%)
Cardiac disorders
Atrial fibrillation	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	1/39 (2.6%)	1
Myocardial infarction	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	1/39 (2.6%)	1
General disorders
Sudden death	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	1/39 (2.6%)	1
Hepatobiliary disorders
Cholecystitis acute	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	1/39 (2.6%)	1
Infections and infestations
Mycetoma mycotic	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	1/39 (2.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	1/39 (2.6%)	1
Malignant melanoma	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	1/39 (2.6%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	1/39 (2.6%)	1
Vascular disorders
Deep vein thrombosis	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	1/39 (2.6%)	1
Other (Not Including Serious) Adverse Events
	Evacetrapib: Single Dose, All Participants		Evacetrapib: Multiple Dose 12 Weeks		Evacetrapib: Multiple Dose 24 Weeks		Evacetrapib: Multiple Dose 52 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/101 (11.9%)		13/30 (43.3%)		17/32 (53.1%)		22/39 (56.4%)
Gastrointestinal disorders
Diarrhoea	1/101 (1%)	1	2/30 (6.7%)	2	3/32 (9.4%)	4	2/39 (5.1%)	3
Dyspepsia	2/101 (2%)	3	2/30 (6.7%)	2	1/32 (3.1%)	1	1/39 (2.6%)	1
Nausea	1/101 (1%)	1	3/30 (10%)	3	1/32 (3.1%)	1	1/39 (2.6%)	1
Vomiting	0/101 (0%)	0	2/30 (6.7%)	2	1/32 (3.1%)	1	0/39 (0%)	0
General disorders
Fatigue	0/101 (0%)	0	0/30 (0%)	0	2/32 (6.3%)	2	0/39 (0%)	0
Pyrexia	0/101 (0%)	0	2/30 (6.7%)	2	0/32 (0%)	0	0/39 (0%)	0
Infections and infestations
Pharyngitis	0/101 (0%)	0	0/30 (0%)	0	2/32 (6.3%)	2	0/39 (0%)	0
Upper respiratory tract infection	0/101 (0%)	0	1/30 (3.3%)	1	4/32 (12.5%)	5	5/39 (12.8%)	7
Urinary tract infection	0/101 (0%)	0	0/30 (0%)	0	2/32 (6.3%)	2	2/39 (5.1%)	3
Viral upper respiratory tract infection	0/101 (0%)	0	1/30 (3.3%)	1	1/32 (3.1%)	2	2/39 (5.1%)	3
Injury, poisoning and procedural complications
Arthropod bite	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	3/39 (7.7%)	3
Contusion	0/101 (0%)	0	2/30 (6.7%)	4	0/32 (0%)	0	1/39 (2.6%)	1
Excoriation	0/101 (0%)	0	0/30 (0%)	0	1/32 (3.1%)	1	3/39 (7.7%)	4
Joint injury	0/101 (0%)	0	0/30 (0%)	0	2/32 (6.3%)	2	1/39 (2.6%)	1
Procedural pain	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	2/39 (5.1%)	2
Rib fracture	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	2/39 (5.1%)	2
Metabolism and nutrition disorders
Decreased appetite	0/101 (0%)	0	1/30 (3.3%)	1	0/32 (0%)	0	2/39 (5.1%)	2
Musculoskeletal and connective tissue disorders
Arthralgia	0/101 (0%)	0	1/30 (3.3%)	1	0/32 (0%)	0	2/39 (5.1%)	3
Back pain	3/101 (3%)	3	1/30 (3.3%)	1	0/32 (0%)	0	4/39 (10.3%)	5
Joint swelling	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	3/39 (7.7%)	4
Pain in extremity	1/101 (1%)	1	0/30 (0%)	0	2/32 (6.3%)	2	0/39 (0%)	0
Nervous system disorders
Dizziness	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	2/39 (5.1%)	3
Headache	7/101 (6.9%)	8	4/30 (13.3%)	6	3/32 (9.4%)	3	3/39 (7.7%)	3
Renal and urinary disorders
Urinary retention	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	2/39 (5.1%)	2
Respiratory, thoracic and mediastinal disorders
Cough	0/101 (0%)	0	3/30 (10%)	3	3/32 (9.4%)	3	0/39 (0%)	0
Nasal congestion	0/101 (0%)	0	0/30 (0%)	0	2/32 (6.3%)	2	0/39 (0%)	0
Oropharyngeal pain	0/101 (0%)	0	0/30 (0%)	0	2/32 (6.3%)	2	4/39 (10.3%)	4
Sinus congestion	0/101 (0%)	0	0/30 (0%)	0	1/32 (3.1%)	1	3/39 (7.7%)	3
Skin and subcutaneous tissue disorders
Dermatitis contact	0/101 (0%)	0	0/30 (0%)	0	1/32 (3.1%)	1	2/39 (5.1%)	2
Vascular disorders
Hypertension	0/101 (0%)	0	0/30 (0%)	0	0/32 (0%)	0	2/39 (5.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.