Trial Outcomes & Findings for Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation (NCT NCT01660321)

NCT ID: NCT01660321

Last Updated: 2012-11-22

Results Overview

Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.

Results posted on

2012-11-22

Participant Flow

Overall Study

Participant milestones

Participant milestones
Measure	Natroba Natroba (Spinosad) Topical Suspension, 0.9%
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Natroba n=26 Participants Natroba (Spinosad) Topical Suspension, 0.9%
Age, Categorical <=18 years	26 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	2 years STANDARD_DEVIATION 0.9 • n=93 Participants
Sex: Female, Male Female	11 Participants n=93 Participants
Sex: Female, Male Male	15 Participants n=93 Participants
Region of Enrollment United States	26 participants n=93 Participants

PRIMARY outcome

Timeframe: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.

Population: Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.

Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%

Outcome measures

Outcome measures
Measure	Natroba n=26 Participants Natroba (Spinosad) Topical Suspension, 0.9%
Cmax for Spinosyn A	NA ng/mL For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples.

PRIMARY outcome

Timeframe: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.

Population: Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.

The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.

Outcome measures

Outcome measures
Measure	Natroba n=26 Participants Natroba (Spinosad) Topical Suspension, 0.9%
Tmax for Spinosyn A	NA hours For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples.

PRIMARY outcome

Timeframe: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.

Population: Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.

Area under the plasma concentration versus time curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.

Outcome measures

Outcome measures
Measure	Natroba n=26 Participants Natroba (Spinosad) Topical Suspension, 0.9%
AUC (0-12) for Spinosyn A	NA ng*hr/mL For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples.

PRIMARY outcome

Timeframe: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.

Population: Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.

Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%

Outcome measures

Outcome measures
Measure	Natroba n=26 Participants Natroba (Spinosad) Topical Suspension, 0.9%
Cmax for Spinosyn D	NA ng/mL For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples.

PRIMARY outcome

Timeframe: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.

Population: Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.

The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.

Outcome measures

Outcome measures
Measure	Natroba n=26 Participants Natroba (Spinosad) Topical Suspension, 0.9%
Tmax for Spinosyn D	NA hours For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples.

PRIMARY outcome

Timeframe: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.

Population: Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.

Area under the plasma concentration versus time curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.

Outcome measures

Outcome measures
Measure	Natroba n=26 Participants Natroba (Spinosad) Topical Suspension, 0.9%
AUC (0-12) for Spinosyn D	NA ng* hr/mL For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples.

PRIMARY outcome

Timeframe: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.

Population: Per Protocol

Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.

Outcome measures

Outcome measures
Measure	Natroba n=26 Participants Natroba (Spinosad) Topical Suspension, 0.9%
Cmax for Benzyl Alcohol	1.123 μg/mL Standard Deviation 0.3071 • Interval 0.5 to 3.0

PRIMARY outcome

Timeframe: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.

Population: Per Protocol

The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.

Outcome measures

Outcome measures
Measure	Natroba n=26 Participants Natroba (Spinosad) Topical Suspension, 0.9%
Tmax for Benzyl Alcohol	0.5 hours Full Range 0.3071 • Interval 0.5 to 3.0

PRIMARY outcome

Timeframe: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.

Population: Since the only benzyl alcohol concentrations above Limit of Quantitation (LOQ) (1.0 μg/mL) were for 1 sample each for 4 subjects and 2 non-consecutive samples for 2 subjects, AUC (0-12) was not summarized.

Area under the plasma concentration versus time curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.

Outcome measures

Outcome measures
Measure	Natroba n=26 Participants Natroba (Spinosad) Topical Suspension, 0.9%
AUC (0-12) for Benzyl Alcohol	NA μg*hr/mL Since the only benzyl alcohol concentrations above LOQ (1.0 μg/mL) were for 1 sample each for 4 subjects and 2 non-consecutive samples for 2 subjects, AUC 0-12 was not summarized.

Adverse Events

Natroba

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Natroba n=26 participants at risk Natroba (Spinosad) Topical Suspension, 0.9%
General disorders Pyrexia	26.9% 7/26 • Number of events 13 • Throughout the study. All Adverse Events (AEs)occurring during the study were recorded at 0 (pretreatment), 0.5, 1, 3, 6, and 12 hours post-treatment by age group and all subjects. Verbatim descriptions of AEs were assigned to system organ classes and preferred terms using the Medical Dictionary for Regulatory Activities (MedDRA) (v14.0).
General disorders Application Site Pruritus	11.5% 3/26 • Number of events 13 • Throughout the study. All Adverse Events (AEs)occurring during the study were recorded at 0 (pretreatment), 0.5, 1, 3, 6, and 12 hours post-treatment by age group and all subjects. Verbatim descriptions of AEs were assigned to system organ classes and preferred terms using the Medical Dictionary for Regulatory Activities (MedDRA) (v14.0).
Skin and subcutaneous tissue disorders Pruritus	7.7% 2/26 • Number of events 13 • Throughout the study. All Adverse Events (AEs)occurring during the study were recorded at 0 (pretreatment), 0.5, 1, 3, 6, and 12 hours post-treatment by age group and all subjects. Verbatim descriptions of AEs were assigned to system organ classes and preferred terms using the Medical Dictionary for Regulatory Activities (MedDRA) (v14.0).
Skin and subcutaneous tissue disorders Erythema	3.8% 1/26 • Number of events 13 • Throughout the study. All Adverse Events (AEs)occurring during the study were recorded at 0 (pretreatment), 0.5, 1, 3, 6, and 12 hours post-treatment by age group and all subjects. Verbatim descriptions of AEs were assigned to system organ classes and preferred terms using the Medical Dictionary for Regulatory Activities (MedDRA) (v14.0).

Additional Information

Director, Quality and Regulatory

ParaPro

Phone: 317-810-6205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place