EMBEDA B4541006 PK of Chronic Pain

Principal Investigator: Nicole Mihalopoulos
Keywords: Chronic Pain , Pfizer , pediatric , Embeda Department: Pediatric Administration
IRB Number: 00076691 Co Investigator:  
Specialty: Pediatrics, General, Pediatrics, General
Sub Specialties: Adolescent Medicine,
Recruitment Status: Recruiting

Contact Information

Rachel Douglas
rachel.douglas@hsc.utah.edu
801-587-2570

Brief Summary

Objectives

Primary

To demonstrate the safety of PF-06412528 in children 7 to 17 years of age treated with PF-06412528 for moderate-to-severe pain.

To characterize the PK of morphine in children 7 to 17 years of age treated with PF-06412528 for moderate-to-severe pain.

Secondary

To determine the exposures of naltrexone and 6--naltrexol in children 7 to 17 years of age treated with PF-06412528 for moderate-to-severe pain.

Inclusion Criteria

1. Subjects between the ages of 7 and 17 years, inclusive, at the time of enrollment.

2. Having confirmed moderate-to-severe pain requiring around-the-clock treatment with an opioid analgesic.

3. Be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent to ≥ 20 mg per day of morphine, for a period of 3 consecutive days immediately prior to first day of dosing with PF-06412528.

4. Have parental/guardian (or adult caregiver) capable of providing informed consent, supervising the storage and administration of study drug, and complying with scheduled visits, treatment plan, and all other study procedures (see Section 4.4).

5. Evidence of a personally signed and dated informed consent document indicating that the subject’s parent or legal/parental/guardian (eg, caregiver) has been informed of all pertinent aspects of the study. Subjects will be required to provide assent in compliance with local regulations and Institutional Review Board (IRB) requirements.

6. Male subjects able to father children and female subjects of childbearing potential who are sexually active and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of PF-06412528. 

7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Caregiver(s)

A subject’s caregiver(s) must meet all of the following criteria for the subject to be eligible for enrollment into the study:

Is ≥18 years of age and has demonstrated responsibility as a caregiver through training to:

  • Recognize the signs and symptoms of opioid toxicity and withdrawal and recognize the need for immediate medical attention;
  • Administer study drug as directed and record time of each dose of study drug;
  • Monitor the subject and record observations of adverse events in the diary.
  • Is available to accompany the subject to clinic visits.
  • Can follow printed instructions in English or Spanish.
  • Is willing and able to give written informed consent for the subject.

Exclusion Criteria

1. A life-expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally.

2. Pregnant female subjects; breastfeeding female subjects; or male subjects with partners currently pregnant. 

3. History of known hypersensitivity to morphine, naltrexone, or opioid products in general.

4. Participation in other studies involving investigational drugs within 30 days prior to study entry and/or study participation. 

5. Significant respiratory depression and/or severe bronchial asthma.

6. Known or suspected of having paralytic ileus or has any other medical condition that, in the opinion of the Investigator, would pose a safety risk to taking PF-06412528.

7. Have other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. This may include, but not be limited to, a clinically significant medical condition (eg, cardiovascular, neurological, renal, hepatic, pulmonary, gastrointestinal [including dysphagia], endocrine, hematological, immunological, rheumatological, metabolic, psychiatric) or physical examination, vital signs, ECG, clinical laboratory test abnormalities during Screening that, in the judgment of the Investigator, would impact the safety of the subject during study participation.

8. Undergone surgery within 30 days prior to the first day of dosing.

9. Positive urine drug test (UDT) at screening for any illicit or scheduled drug not prescribed for the subject.

10. Subjects who are children of or related to investigational site staff members directly involved in the conduct of the study, site staff members otherwise supervised by the Investigator, or Pfizer employees directly involved in the conduct of the study.

11.Subject endorses a 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) ideation section or reports any suicidal behavior.  (Section 7.4.1).\

12. History of sleep apnea within the past year that would compromise the safety of the subject in the judgment of the investigator.
13. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal at the Screening Visit.
14. Epidural opioid <2 hours prior to the first dose of study drug.
15. Any planned surgery during the course of the study, with the exception of the placement of central or peripheral venous access devices.