Evaluate The Pharmacokinetics and Safety Of Oxycodone Oral Solution In Pediatric and Adolescent Subjects

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to characterize the pharmacokinetics and to evaluate the safety of single and multiple doses of Oxycodone Oral Solution in pediatric and adolescent subjects for postoperative pain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VistaPharm, Inc.
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

1. Is male or female <17 years of age at the time of dosing.

2. Subject 2 to <17 years of age, be in at least the 25% for weight according to the Center for Disease Control pediatric growth charts and weighs at least 28 lb at the time of dosing with study drug.

3. Is generally healthy as documented by medical history (except for the condition for which the procedure is being performed); physical examination (including, but not limited to, the cardiovascular, gastrointestinal, respiratory, and central nervous systems); vital sign assessments; 12-lead electrocardiograms; clinical laboratory assessments; and general observations. Has a negative serum pregnancy test at Screening and predose check in for females of childbearing potential.

4. Is an outpatient for a surgical procedure and is expected to remain hospitalized for at least 24 hours after dosing with study drug.

5. Is anticipated to have postsurgical pain requiring a parenteral analgesic regimen using a short-acting opioid analgesic and is anticipated to be switched to an oral opioid for at least 1 dose (according to institution standard of care).

6. Has an indwelling access catheter for blood sampling.

7. Agrees to comply with all protocol requirements. If not old enough, the legally responsible parent(s) or legal guardian(s) must agree to comply with all protocol requirements.

8. Has been informed of the nature of the study and informed consent and assent (as appropriate) have been obtained from the legally responsible parent(s) or legal guardian(s) and the subject, respectively, in accordance with institutional review board requirements.

Exclusion Criteria:

1. Has the presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (except for the condition for which the procedure is being performed) as determined by the clinical investigator.

2. Has any clinical laboratory test result outside the normal range.

3. Has a positive test result for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody.

4. Had a clinically significant illness, except for the condition for which the procedure is being performed, in the 28 days before dosing with study drug as determined by the clinical investigator.

5. Is a lactating or breastfeeding female.

6. Uses any medication known to be an inhibitor or inducer of CYP3A4 within 14 days (for inhibitors such as the azole-antifungal agents voriconazole and ketoconazole, macrolide antibiotics such as erythromycin, and protease inhibitors such as ritonavir) or 28 days (for inducers such as rifampin, carbamazepine, and phenytoin) of dosing with study drug. Use of all other prescription medications, except required pre-op medications and birth control, is prohibited within 3 days of dosing with study drug. Use of any over-the-counter medications (including herbal or dietary supplements and therapeutic doses of vitamins), except for required pre-op medications, is prohibited within 24 hours of dosing with study drug, with the exception of topical spermicide. Use of St. John's wort is prohibited from 28 days before dosing until 14 days after dosing. Standard daily dose multivitamins (nontherapeutic doses) may be taken until enrollment into the study but will be restricted during the study.

7. Consumes alcohol-, caffeine-, or xanthine-containing products within 48 hours before dosing and during periods when blood samples are collected.

8. Consumes grapefruit, grapefruit products, Seville oranges, or pomelo-containing products within 14 days of dosing. Fruit juices, with the exception of apple and grape, will be prohibited during the study.

9. Is a smoker or has used nicotine or nicotine-containing products within 30 days of dosing.

10. Has a history of alcohol or drug addiction or abuse within the last year.

11. Subject 2 to <17 years of age, has a positive urine test result for drugs of abuse (amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates, phencyclidine, and benzodiazepines) or alcohol at Screening (not required for subjects less than 2 years of age).

12. Donated blood within 28 days or plasma within 14 days of dosing or plans to donate them within 4 weeks after completing the study.

13. Has a history of relevant drug allergies, food allergies, or both (i.e., allergy to oxycodone, allergy to related drugs, or any significant food allergy that could interfere with the study).

14. Is intolerant to direct venipuncture.

15. Received an investigational drug within 28 days of dosing.

16. Has taken oxycodone or oxymorphone within the 48 hours before anticipated dosing with study drug.

17. Is not suitable for entry into the study in the opinion of the investigator.