A Study of LY2963016 in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01634165
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Duration (Months): 2
• Patients Per Site Per Month: 11.8

Study Details

Study Description

Brief Summary

This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There will be at least 6 days between each injection.

The study will compare LY2963016 to Lantus at two different doses.

This study is approximately 10 weeks long, not including screening. Screening is required within 4 weeks of the start of the study.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: LY2963016; Drug: Lantus	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Pharmacokinetics and Pharmacodynamics of LY2963016 Compared to Lantus® in Healthy Subjects Following Two Single Subcutaneous Doses
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.3 U/kg LY2963016 Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016	Drug: LY2963016; Administered subcutaneously
Experimental: 0.3 U/kg Lantus Single 0.3 U/kg subcutaneous dose of Lantus	Drug: Lantus; Administered subcutaneously
Experimental: 0.6 U/kg LY2963016 Single 0.6 U/kg subcutaneous dose of LY2963016	Drug: LY2963016; Administered subcutaneously
Experimental: 0.6 U/kg Lantus Single 0.6 U/kg subcutaneous dose of Lantus	Drug: Lantus; Administered subcutaneously

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)] [Predose up to 24 hours after administration of study drug]

   Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.

2. Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax) [Predose up to 24 hours after administration of study drug]

Secondary Outcome Measures

1. Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus [Predose up to 24 hours after administration of study drug]

   Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.

2. Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus [Predose up to 24 hours after administration of study drug]

   Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.

3. Maximum Glucose Infusion Rate (Rmax) [Postdose up to 24 hours after administration of study drug]

   Rmax is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.

4. Total Amount of Glucose Infused (Gtot) [Postdose up to 24 hours after administration of study drug]

   Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy males or females

• Women must be either surgically sterile, post-menopausal, or agree to use a reliable method of birth control during the study

• Have a body mass index between 18.5 and 29.9 kilograms per meter squared (kg/m²)

• Are nonsmokers and have not smoked for at least 6 months prior to entering the study

• Have normal blood pressures and pulse rates at screening, as determined by the investigator

• Have an electrocardiogram (ECG) at screening considered as within normal limits by the investigator

• Have clinical laboratory test results within normal reference range for the population

• Have fasting plasma glucose <110 milligrams per deciliter (mg/dL) (<6.0 micromoles per liter [mmol/L]) at screening

• Have venous access sufficient to allow for blood sampling, intravenous drug administration, and clamp procedures as per the protocol

• Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site

Exclusion Criteria:

• Are persons who have previously completed or withdrawn from this study

• Are currently enrolled in or have discontinued within the last 30 days from a clinical trial involving an investigational drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

• Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin

• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

• Show evidence of significant active neuropsychiatric disease

• Show evidence of current use of known drugs of abuse or have a history of use within the past year

• Have a history of first-degree relatives known to have diabetes mellitus

• Show evidence of an acute infection with fever or infectious disease at the time of study entry

• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening

• Have positive hepatitis B surface antigens at screening

• Intend to use over-the-counter medication within 7 days or prescription medication within 14 days prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement, or birth control methods)

• Have donated blood or had a blood loss of 450 milliliters (mL) 3 months prior to study enrollment

• Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to stop alcohol consumption from 48 hours prior to each dosing until discharged from the clinical research unit (CRU)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Singapore		Singapore	117597

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: NCT01634165
• Other Study ID Numbers: 14676; I4L-MC-ABEM
• First Posted: Jul 6, 2012
• Last Update Posted: Oct 7, 2014
• Last Verified: Oct 1, 2014

• Additional relevant MeSH terms: Insulin Glargine

Study Results

Participant Flow

Pre-assignment Detail	This was a 4-treatment, 4-period, crossover, euglycemic clamp study. Participants were randomly assigned to 1 of 4 dosing sequences.

Arm/Group Title	0.3 U/kg LY, 0.6 U/kg LY, 0.3 U/kg Lantus, 0.6 U/kg Lantus	0.6 U/kg LY, 0.6 U/kg Lantus, 0.3 U/kg LY, 0.3 U/kg Lantus	0.3 U/kg Lantus, 0.3 U/kg LY, 0.6 U/kg Lantus, 0.6 U/kg LY	0.6 U/kg Lantus, 0.3 U/kg Lantus, 0.6 U/kg LY, 0.3 U/kg LY
Arm/Group Description	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.3 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg Lantus during Period 2; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.3 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.6 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg Lantus during Period 2; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
Period Title: Period 1
STARTED	6	6	6	6
Received at Least 1 Dose of Study Drug	6	6	6	6
COMPLETED	6	6	6	6
NOT COMPLETED	0	0	0	0
Period Title: Period 1
STARTED	6	6	6	6
COMPLETED	6	5	6	6
NOT COMPLETED	0	1	0	0
Period Title: Period 1
STARTED	6	5	6	6
COMPLETED	6	5	6	6
NOT COMPLETED	0	0	0	0
Period Title: Period 1
STARTED	6	5	6	6
COMPLETED	6	5	6	6
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016, or 0.6 U/kg LY2963016, or 0.3 U/kg Lantus, or 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
Overall Participants	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.1 (7.7)
Sex: Female, Male (Count of Participants)
Female	4 16.7%
Male	20 83.3%
Race/Ethnicity, Customized (participants) [Number]
Asian	24 100%
Region of Enrollment (participants) [Number]
Singapore	24 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]
Description	Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.
Time Frame	Predose up to 24 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-∞). Participants were analyzed based on the treatment they received.

Arm/Group Title	0.3 U/kg LY2963016	0.6 U/kg LY2963016	0.3 U/kg Lantus	0.6 U/kg Lantus
Arm/Group Description	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
Measure Participants	23	24	22	24
Geometric Mean (Geometric Coefficient of Variation) [picomoles*hour per liter (pmol*h/L)]	2330 (39)	4470 (15)	2390 (33)	4310 (51)

2. Primary Outcome

Title	Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)
Time Frame	Predose up to 24 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

All participants who received study drug and had sufficient pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received.

Arm/Group Title	0.3 U/kg LY2963016	0.6 U/kg LY2963016	0.3 U/kg Lantus	0.6 U/kg Lantus
Arm/Group Description	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
Measure Participants	23	24	23	24
Geometric Mean (Geometric Coefficient of Variation) [picomoles per liter (pmol/L)]	108 (20)	180 (28)	105 (33)	174 (38)

3. Secondary Outcome

Title	Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus
Description	Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.
Time Frame	Predose up to 24 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.

Arm/Group Title	0.3 U/kg LY2963016	0.6 U/kg LY2963016	0.3 U/kg Lantus	0.6 U/kg Lantus
Arm/Group Description	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
Measure Participants	23	24	23	24
Geometric Mean (Geometric Coefficient of Variation) [picomoles*hour per liter (pmol*h/L)]	1730 (20)	3160 (27)	1690 (30)	2940 (45)

4. Secondary Outcome

Title	Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus
Description	Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.
Time Frame	Predose up to 24 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-tlast). Participants were analyzed based on the treatment they received.

Arm/Group Title	0.3 U/kg LY2963016	0.6 U/kg LY2963016	0.3 U/kg Lantus	0.6 U/kg Lantus
Arm/Group Description	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
Measure Participants	23	24	23	24
Geometric Mean (Geometric Coefficient of Variation) [picomoles*hour per liter (pmol*h/L)]	1730 (20)	3160 (27)	1670 (28)	2940 (45)

5. Secondary Outcome

Title	Maximum Glucose Infusion Rate (Rmax)
Description	Rmax is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.
Time Frame	Postdose up to 24 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

All participants who received study drug and had Rmax measurements. Participants were analyzed based on the treatment they received.

Arm/Group Title	0.3 U/kg LY2963016	0.6 U/kg LY2963016	0.3 U/kg Lantus	0.6 U/kg Lantus
Arm/Group Description	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
Measure Participants	23	24	23	24
Geometric Mean (Geometric Coefficient of Variation) [milligrams/kilograms/minute (mg/kg/min)]	1.81 (100)	3.05 (59)	1.70 (92)	3.25 (54)

6. Secondary Outcome

Title	Total Amount of Glucose Infused (Gtot)
Description	Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.
Time Frame	Postdose up to 24 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

All participants who received study drug and had Gtot measurements. Participants were analyzed based on the treatment they received.

Arm/Group Title	0.3 U/kg LY2963016	0.6 U/kg LY2963016	0.3 U/kg Lantus	0.6 U/kg Lantus
Arm/Group Description	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.	Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
Measure Participants	23	24	23	24
Geometric Mean (Geometric Coefficient of Variation) [milligrams per kilograms (mg/kg)]	1060 (178)	2260 (80)	1050 (130)	2590 (62)

Adverse Events

Arm/Group Title	0.3 U/kg LY2963016		0.6 U/kg LY2963016		0.3 U/kg Lantus		0.6 U/kg Lantus
Arm/Group Description	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.		Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.		Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.		Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
All Cause Mortality
	0.3 U/kg LY2963016		0.6 U/kg LY2963016		0.3 U/kg Lantus		0.6 U/kg Lantus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	0.3 U/kg LY2963016		0.6 U/kg LY2963016		0.3 U/kg Lantus		0.6 U/kg Lantus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)		0/23 (0%)		1/24 (4.2%)
Blood and lymphatic system disorders
Anaemia	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	1/24 (4.2%)	1
Other (Not Including Serious) Adverse Events
	0.3 U/kg LY2963016		0.6 U/kg LY2963016		0.3 U/kg Lantus		0.6 U/kg Lantus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/23 (17.4%)		10/24 (41.7%)		10/23 (43.5%)		12/24 (50%)
Cardiac disorders
Palpitations	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	1/24 (4.2%)	1
Gastrointestinal disorders
Abdominal discomfort	0/23 (0%)	0	1/24 (4.2%)	1	0/23 (0%)	0	1/24 (4.2%)	1
Abdominal distension	0/23 (0%)	0	0/24 (0%)	0	1/23 (4.3%)	1	0/24 (0%)	0
Abdominal pain lower	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	1/24 (4.2%)	1
Diarrhoea	0/23 (0%)	0	1/24 (4.2%)	1	0/23 (0%)	0	0/24 (0%)	0
Nausea	0/23 (0%)	0	0/24 (0%)	0	1/23 (4.3%)	1	0/24 (0%)	0
Vomiting	0/23 (0%)	0	2/24 (8.3%)	3	0/23 (0%)	0	1/24 (4.2%)	3
General disorders
Application site erythema	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	1/24 (4.2%)	1
Application site haematoma	1/23 (4.3%)	1	1/24 (4.2%)	1	2/23 (8.7%)	2	3/24 (12.5%)	3
Injection site erythema	0/23 (0%)	0	1/24 (4.2%)	1	0/23 (0%)	0	0/24 (0%)	0
Injection site pruritus	0/23 (0%)	0	1/24 (4.2%)	1	0/23 (0%)	0	0/24 (0%)	0
Injury, poisoning and procedural complications
Excoriation	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	1/24 (4.2%)	1
Post procedural swelling	1/23 (4.3%)	1	2/24 (8.3%)	2	3/23 (13%)	3	1/24 (4.2%)	1
Procedural pain	1/23 (4.3%)	1	1/24 (4.2%)	1	4/23 (17.4%)	4	2/24 (8.3%)	2
Musculoskeletal and connective tissue disorders
Joint swelling	0/23 (0%)	0	0/24 (0%)	0	1/23 (4.3%)	1	0/24 (0%)	0
Myalgia	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	1/24 (4.2%)	1
Nervous system disorders
Dizziness	0/23 (0%)	0	0/24 (0%)	0	1/23 (4.3%)	1	2/24 (8.3%)	3
Head discomfort	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	1/24 (4.2%)	1
Headache	0/23 (0%)	0	1/24 (4.2%)	1	1/23 (4.3%)	1	0/24 (0%)	0
Lethargy	0/23 (0%)	0	1/24 (4.2%)	1	0/23 (0%)	0	0/24 (0%)	0
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea	1/23 (4.3%)	1	0/24 (0%)	0	1/23 (4.3%)	1	1/24 (4.2%)	1
Skin and subcutaneous tissue disorders
Erythema	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	1/24 (4.2%)	1
Hyperhidrosis	0/23 (0%)	0	1/24 (4.2%)	1	1/23 (4.3%)	1	0/24 (0%)	0
Skin discolouration	0/23 (0%)	0	0/24 (0%)	0	1/23 (4.3%)	1	0/24 (0%)	0
Skin exfoliation	0/23 (0%)	0	1/24 (4.2%)	1	0/23 (0%)	0	0/24 (0%)	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.