Trial Outcomes & Findings for Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM) (NCT NCT01428076)

NCT ID: NCT01428076

Last Updated: 2021-04-21

Results Overview

Cmax measured and adjusted for weight

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 21 participants
• Primary outcome timeframe: pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose
• Results posted on: 2021-04-21

Participant Flow

Participant milestones

Measure	Polidocanol 1% polidocanol injectable foam 1% concentration	Polidocanol 2% polidocanol injectable foam 2% concentration
Overall Study STARTED	9	12
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Polidocanol 1% polidocanol injectable foam 1% concentration	Polidocanol 2% polidocanol injectable foam 2% concentration
Overall Study Adverse Event	0	1

Baseline Characteristics

Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)

Baseline characteristics by cohort

Measure	Polidocanol 1% n=9 Participants polidocanol injectable foam 1% concentration	Polidocanol 2% n=12 Participants polidocanol intravenous foam 2% concentration	Total n=21 Participants Total of all reporting groups
Age, Continuous	54.0 years STANDARD_DEVIATION 9.62 • n=5 Participants	49.9 years STANDARD_DEVIATION 11.4 • n=7 Participants	51.7 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI	27.1 kg/m^2 STANDARD_DEVIATION 2.52 • n=5 Participants	27.1 kg/m^2 STANDARD_DEVIATION 5.19 • n=7 Participants	27.1 kg/m^2 STANDARD_DEVIATION 4.16 • n=5 Participants

PRIMARY outcome

Timeframe: pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose

Population: PK population

Cmax measured and adjusted for weight

Outcome measures

Measure	Males-polidocanol 1% n=3 Participants polidocanol injectable foam 1% concentration	Males-polidocanol 2% n=6 Participants polidocanol injectable foam 2% concentration	Females-polidocanol 1% n=6 Participants polidocanol injectable foam 1% concentration	Females- Polidocanol 2% n=5 Participants polidocanol injectable foam 2% concentration
Weight-adjusted Polidocanol Cmax (Serum)	584.1 ng/mL Standard Deviation 142.8	1188.7 ng/mL Standard Deviation 341.7	840.7 ng/mL Standard Deviation 437.6	1189.6 ng/mL Standard Deviation 331.2

Adverse Events

Polidocanol 1%

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Polidocanol 2%

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Polidocanol 1% n=9 participants at risk polidocanol injectable foam 1% concentration	Polidocanol 2% n=12 participants at risk polidocanol injectable foam 2% concentration
Gastrointestinal disorders Abdominal pain upper	11.1% 1/9 • Number of events 1	0.00% 0/12
General disorders Extravasation	11.1% 1/9 • Number of events 1	0.00% 0/12
Infections and infestations Respiratory tract infection	11.1% 1/9 • Number of events 1	0.00% 0/12
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/9	8.3% 1/12 • Number of events 1
Musculoskeletal and connective tissue disorders muscle spasm	11.1% 1/9 • Number of events 1	0.00% 0/12
Musculoskeletal and connective tissue disorders neck pain	0.00% 0/9	8.3% 1/12 • Number of events 1
Musculoskeletal and connective tissue disorders pain in extremity	22.2% 2/9 • Number of events 2	8.3% 1/12 • Number of events 1
Nervous system disorders headache	22.2% 2/9 • Number of events 2	25.0% 3/12 • Number of events 3
Renal and urinary disorders hematuria	0.00% 0/9	8.3% 1/12 • Number of events 1
Respiratory, thoracic and mediastinal disorders epistaxis	0.00% 0/9	8.3% 1/12 • Number of events 1
Vascular disorders deep vein thrombosis	0.00% 0/9	16.7% 2/12 • Number of events 2
Vascular disorders thrombosis	0.00% 0/9	8.3% 1/12 • Number of events 1
Vascular disorders venous thrombosis limb	11.1% 1/9 • Number of events 1	0.00% 0/12

Additional Information

David Wright MB FRCS

BTG International Inc.

Phone: 610-278-1660

Email: david.wright@btgplc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place