| Eligibility |
Inclusion Criteria:
A subject will be eligible for inclusion in the study if he or she meets all of the
following criteria:
1. Is accompanied and/or represented by a parent or guardian able to comprehend and sign
the informed consent document.
2. Is able to understand and provide assent to an age-appropriate subject assent form (as
defined by local practice or regulation).
3. Subject or parent/guardian is able to communicate with the Investigator and comply
with the requirements of the protocol.
4. Is male or female =12 to <17 years of age at the time of dosing.
5. Is within the 10th and 90th percentiles for weight according to age.
6. Has a body mass index (BMI) within the 5th and 85th percentiles by age.
7. Has an oxygen saturation of at least 98%.
8. Will be undergoing a diagnostic procedure or surgery on or through the nasal mucous
membranes of either one or both nostrils.
9. Is a non-pregnant, non-lactating female (if of child-bearing potential and sexually
active) or is a male (if sexually active with a partner of child-bearing potential)
who agrees to use a medically acceptable and effective birth control method from the
time of the Screening Visit and then for 8 days following the last dose of GOPRELTO®
nasal solution. Medically acceptable methods of contraception that may be used by the
participant and/or his/her partner include: abstinence, FDA-approved hormonal
contraceptives (i.e., birth control pill, injection, patch or vaginal ring),
diaphragm, intrauterine device, double-barrier methods, surgical sterilization, and
progestin implant or injection. Prohibited methods include the rhythm method or
withdrawal.
Exclusion Criteria:
- Exclusion
A subject will be excluded from the study if he or she meets any of the following criteria:
1. Has a history of seizures.
2. Has a known hypersensitivity allergy to any ester-based anesthetics including cocaine
hydrochloride, procaine, tetracaine, chloroprocaine, dibucaine, or benzocaine, and/or
any other compounds of the drugs and /or devices that are part of this protocol (amide
based anesthetics are NOT exclusionary).
3. Has previously received intranasal topical cocaine within 14 days prior to the
Screening Visit.
4. Has participated in an investigational study or received an investigational drug
within 30 days preceding Treatment Day 1.
5. Has a history of abuse of controlled substances, nasal or otherwise.
6. Has a positive test result for drugs of abuse at the Screening Visit: amphetamines,
barbiturates, cannabinoids, cocaine metabolites, opiates, and oxycodone via a urine
test. Alcohol is prohibited within 24 hours prior to Treatment Day 1.
7. Is a pregnant female or nursing mother, or has a positive urine pregnancy test at the
Screening Visit or on Treatment Day 1.
8. Use of any serotonin-norepinephrine reuptake inhibitors/selective serotonin reuptake
inhibitor (SNRIs/SSRIs) up to 14 days prior to the Screening Visit or has a need to
use these drugs at any time throughout the duration of the study.
9. Use of monoamine oxidase inhibitor (MAO) drugs up to 14 days prior to the Screening
Visit or has a need to use these drugs at any time throughout the duration of the
study.
10. Use of nasal products such as decongestants (oxymetazoline, phenylephrine),
amphetamines, stimulant prescription and nonprescription products such as
catecholamines (direct and indirect-acting sympathomimetics), bronchial inhalers
containing sympathomimetics (epinephrine or other beta-receptor agonists), or herbal
products in the 2 days prior to the Screening Visit or has a need to use these drugs
through or on Treatment Day 1.
11. Use of disulfiram.
12. Planned or anticipated need for additional vasoconstrictor agents such as epinephrine
or phenylephrine.
13. Suffers from a condition, other than the need for a diagnostic procedure or surgery on
or through the nasal mucous membranes, which in the opinion of the Investigator, would
compromise the safety of the subject, the quality of the data, or the normal wound
healing process.
14. Has severely traumatized mucosa or septum in the nasal cavities or has damage to the
nasal space that will not allow pledgets to be inserted.
15. Has a recent or active history of myocardial infarction, coronary artery disease,
congestive heart failure, unstable angina, or uncontrolled hypertension. Uncontrolled
hypertension is defined as systolic blood pressure or diastolic blood pressure greater
than or equal to the 95th percentile by sex, age and height.
16. Has an ECG finding of any abnormality at the Screening Visit. Generally, these
exclusionary abnormalities are current or prior myocardial ischemia or infarction,
dysrhythmia, or risk of serious dysrhythmia (such as prolonged QT interval). An
exception to this would be if sinus bradycardia or sinus tachycardia is present. The
Investigator must determine whether this finding is clinically significant and
exclusionary.
17. Has a known personal or family history of hereditary pseudocholinesterase deficiency.
18. Has a known or suspected personal or family history of pheochromocytoma. Study
participants will be specifically asked if they have been treated for a
pheochromocytoma previously or if they have a family member who has been diagnosed
with pheochromocytoma (as 10% of these are familial).
19. Has any laboratory result outside the normal laboratory reference range deemed
clinically significant by the Investigator.
20. Has a history of or current, hepatic, or renal disease.
21. Is not suitable for entry into the study, in the opinion of the Investigator. Note: A
one-time retest is permitted for any blood test if the original sample was hemolyzed.
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