Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic

• Sponsor: Bial - Portela C S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01519284
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 5
• Duration (Months): 19
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: BIA 9-1067 5 mg; Drug: Entacapone; Drug: Placebo; Drug: levodopa/carbidopa; Drug: BIA 9-1067 15 mg; Drug: BIA 9-1067 30 mg	Phase 1

Detailed Description

Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group 1 Placebo at all the dosing times	Drug: Placebo; placebo (four times a day); Other Names: PLC, placebo
Experimental: Group 2 Day 1 to 7: BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose	Drug: BIA 9-1067 5 mg; BIA 9-1067 OPC, Opicapone 5 mg; Other Names: OPC, Opicapone ; Drug: Placebo; placebo (four times a day); Other Names: PLC, placebo ; Drug: levodopa/carbidopa; standard release levodopa/carbidopa 100/25 mg (single-dose)
Experimental: Group 3 Day 1 to 7: BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose	Drug: Placebo; placebo (four times a day); Other Names: PLC, placebo ; Drug: levodopa/carbidopa; standard release levodopa/carbidopa 100/25 mg (single-dose); Drug: BIA 9-1067 15 mg; BIA 9-1067 OPC, Opicapone 15 mg; Other Names: OPC, Opicapone
Experimental: Group 4 Day 1 to 7: BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose	Drug: Placebo; placebo (four times a day); Other Names: PLC, placebo ; Drug: levodopa/carbidopa; standard release levodopa/carbidopa 100/25 mg (single-dose); Drug: BIA 9-1067 30 mg; BIA 9-1067 OPC, Opicapone 30 mg; Other Names: OPC, Opicapone
Experimental: Group 5 Day 1 to 7: Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose Day 8: Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose	Drug: Entacapone; Entacapone 200 mg; Drug: Placebo; placebo (four times a day); Other Names: PLC, placebo ; Drug: levodopa/carbidopa; standard release levodopa/carbidopa 100/25 mg (single-dose)

Outcome Measures

Primary Outcome Measures

1. Cmax - Maximum Plasma Concentration of Levodopa [8 days]

   Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days

Secondary Outcome Measures

1. Tmax - Time to Reach Maximum Plasma Concentration of Levodopa [8 days]

   Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.

2. AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. [8 days]

   AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days

3. AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity [8 days]

   AUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Able and willing to give written informed consent.

• Male or female subjects aged between 18 and 45 years, inclusive.

• Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.

• Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.

• Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.

• Clinical laboratory test results clinically acceptable at screening and admission to the treatment period.

• Negative screen for alcohol and drugs of abuse at screening and admission to the treatment period.

• Non-smokers or ex-smokers for at least 3 months.

• (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the subject) and condoms (by the partner) or diaphragm (by the subject) and condoms (by the partner) or spermicide (by the subject) and condoms (by the partner).

• (If female) She had a negative urine pregnancy test at screening and admission to the treatment period.

Exclusion Criteria:

• Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.

• Clinically relevant surgical history.

• Any abnormality in the coagulation tests.

• Any abnormality in the liver function tests.

• A history of relevant atopy or drug hypersensitivity.

• A history or presence of narrow-angle glaucoma.

• A suspicious undiagnosed skin lesions or a history of melanoma.

• History of alcoholism or drug abuse.

• Consumed more than 14 units of alcohol a week.

• Significant infection or known inflammatory process at screening or admission to the treatment period.

• Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the treatment period.

• Had used non-selective monoamine oxidase (MAO) inhibitors within 2 weeks of admission to the treatment period.

• Had used medicines within 2 weeks of admission to the treatment period that may have affected the safety or other study assessments, in the investigator's opinion.

• Had previously received BIA 9-1067.

• Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.

• Had participated in more than 2 clinical trials within the 12 months prior to screening.

• Had donated or received any blood or blood products within the 3 months prior to screening.

• Vegetarians, vegans or had medical dietary restrictions.

• Cannot communicate reliably with the investigator.

• Unlikely to co-operate with the requirements of the study.

• Unwilling or unable to gave written informed consent.

• (If female) She was pregnant or breast-feeding.

• (If female) She was of childbearing potential and she did not use an approved effective contraceptive method or she used oral contraceptives.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bial - Portela & Cª, S.A.	S. Mamede do Coronado		Portugal	4745-457

Sponsors and Collaborators

• Bial - Portela C S.A.

Investigators

• Principal Investigator: Manuel Vaz-da-Silva, MD, PhD, BIAL - Portela & Cª S.A

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bial - Portela C S.A.
• ClinicalTrials.gov Identifier: NCT01519284
• Other Study ID Numbers: BIA-91067-114
• First Posted: Jan 26, 2012
• Last Update Posted: Aug 20, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Bial - Portela C S.A.: Parkinson Disease; BIA 9-1067
• Additional relevant MeSH terms: Parkinson Disease; Levodopa; Carbidopa; Opicapone; Entacapone

Study Results

Participant Flow

Arm/Group Title	Group 1	Group 2	Group 3	Group 4	Group 5
Arm/Group Description	Placebo at all the dosing times	Day 1 to 7: BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose Day 8: Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
Period Title: Overall Study
STARTED	16	16	18	16	16
COMPLETED	16	16	16	16	16
NOT COMPLETED	0	0	2	0	0

Baseline Characteristics

Arm/Group Title	Group 1	Group 2	Group 3	Group 4	Group 5	Total
Arm/Group Description	Placebo at all the dosing times Placebo: placebo (four times a day)	Day 1 to 7: BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose BIA 9-1067 5 mg: BIA 9-1067 OPC, Opicapone 5 mg Placebo: placebo (four times a day) levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)	Day 1 to 7: BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose Placebo: placebo (four times a day) levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose) BIA 9-1067 15 mg: BIA 9-1067 OPC, Opicapone 15 mg	Day 1 to 7: BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose Placebo: placebo (four times a day) levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose) BIA 9-1067 30 mg: BIA 9-1067 OPC, Opicapone 30 mg	Day 1 to 7: Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose Day 8: Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose Entacapone: Entacapone 200 mg Placebo: placebo (four times a day) levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)	Total of all reporting groups
Overall Participants	16	16	18	16	16	82
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	16 100%	16 100%	18 100%	16 100%	16 100%	82 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	8 50%	8 50%	9 50%	8 50%	8 50%	41 50%
Male	8 50%	8 50%	9 50%	8 50%	8 50%	41 50%

Outcome Measures

1. Primary Outcome

Title	Cmax - Maximum Plasma Concentration of Levodopa
Description	Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days
Time Frame	8 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2	Group 3	Group 4	Group 5
Arm/Group Description	Placebo at all the dosing times	Day 1 to 7: BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose Day 8: Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
Measure Participants	16	16	16	16	16
Mean (Standard Deviation) [ng/mL]	1076 (292.7)	1106 (420.3)	943 (325.3)	981 (488.5)	928 (245)

2. Secondary Outcome

Title	Tmax - Time to Reach Maximum Plasma Concentration of Levodopa
Description	Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.
Time Frame	8 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2	Group 3	Group 4	Group 5
Arm/Group Description	Placebo at all the dosing times	Day 1 to 7: BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose Day 8: Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
Measure Participants	16	16	16	16	16
Median (Full Range) [hours]	0.75	0.75	0.75	0.75	0.75

3. Secondary Outcome

Title	AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.
Description	AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days
Time Frame	8 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2	Group 3	Group 4	Group 5
Arm/Group Description	Placebo at all the dosing times	Day 1 to 7: BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose Day 8: Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
Measure Participants	16	16	16	16	16
Mean (Standard Deviation) [ng.h/mL]	1578 (320.3)	1785 (574.8)	2102 (569.6)	2202 (605.6)	2146 (538.6)

4. Secondary Outcome

Title	AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity
Description	AUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.
Time Frame	8 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2	Group 3	Group 4	Group 5
Arm/Group Description	Placebo at all the dosing times	Day 1 to 7: BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose	Day 1 to 7: Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose Day 8: Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
Measure Participants	16	16	16	16	16
Mean (Standard Deviation) [ng.h/mL]	1649 (313.3)	1873 (571.3)	2233 (578.3)	2381 (623.8)	2253 (540.7)

Adverse Events

Arm/Group Title	Group 1		Group 2		Group 3		Group 4		Group 5
Arm/Group Description	Placebo at all the dosing times		Day 1 to 7: BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose		Day 1 to 7: BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose		Day 1 to 7: BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose		Day 1 to 7: Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose Day 8: Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
All Cause Mortality
	Group 1		Group 2		Group 3		Group 4		Group 5
	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)
Serious Adverse Events
	Group 1		Group 2		Group 3		Group 4		Group 5
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)
Pregnancy, puerperium and perinatal conditions
spontaneous abortion	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Group 1		Group 2		Group 3		Group 4		Group 5
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/16 (37.5%)		9/16 (56.3%)		10/17 (58.8%)		12/16 (75%)		7/16 (43.8%)
Cardiac disorders
Palpitations	1/16 (6.3%)		0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)
Eye disorders
Conjunctivitis	1/16 (6.3%)		0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Edema eyelid	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Gastrointestinal disorders
Abdominal pain	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)
Abdominal pain upper	0/16 (0%)		0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)
Aerophagia	0/16 (0%)		0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)
Constipation	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)
Diarrhoea	0/16 (0%)		0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)
Dyspepsia	0/16 (0%)		0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)
Flatulence	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)
Nausea	1/16 (6.3%)		0/16 (0%)		0/17 (0%)		1/16 (6.3%)		1/16 (6.3%)
Rectal haemorrhage	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Vomiting	0/16 (0%)		0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)
General disorders
Application site haematoma	1/16 (6.3%)		0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Catheter site phlebitis	0/16 (0%)		0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)
Device breakage	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)
Injection site haematoma	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)
Infections and infestations
Nasopharyngitis	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)
Pharyngitis	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)
Rhinitis	0/16 (0%)		0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)
Tooth infection	0/16 (0%)		0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)
Upper respiratory tract	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)
Urinary tract infection	0/16 (0%)		0/16 (0%)		0/17 (0%)		2/16 (12.5%)		0/16 (0%)
Injury, poisoning and procedural complications
Face injury	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Post procedural complication	0/16 (0%)		0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)
Investigations
CK increased	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		2/16 (12.5%)		0/16 (0%)
Weight increased	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)
Metabolism and nutrition disorders
Anorexia	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		1/16 (6.3%)		1/16 (6.3%)
Nervous system disorders
Dizziness	1/16 (6.3%)		0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)
Headache	2/16 (12.5%)		0/16 (0%)		2/17 (11.8%)		2/16 (12.5%)		1/16 (6.3%)
Migraine	0/16 (0%)		0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)
Presyncope	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		3/16 (18.8%)		0/16 (0%)
Radiculopathy	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)
Somnolence	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)
Psychiatric disorders
Acute stress disorder	1/16 (6.3%)		0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Anxiety	0/16 (0%)		0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)
Insomnia	0/16 (0%)		0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)
Renal and urinary disorders
Pollakiuria	1/16 (6.3%)		1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Reproductive system and breast disorders
Menstrual discomfort	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Nasal congestion	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Oropharyngeal pain	0/16 (0%)		0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)
Skin and subcutaneous tissue disorders
Erythema	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)
Macule	0/16 (0%)		1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Pruritus	1/16 (6.3%)		0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)
Skin reaction	0/16 (0%)		0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (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.