A Phase 1b, Randomized 2-Part Single-Center Study to Evaluate the PK and Safety of Multiple Ascending Oral Doses of PF614 and the Food Effect and BA/BE of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects

PF614-102

This is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A) and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B). Both parts of the study will be conducted in healthy adult subjects.

2021-09-08

2022-03-21

2022-03-21

Completed

Early phase I

84

Inclusion Criteria: * Males or females, ages 18-50 years in good general health, * BMI between 18 and 32 kg/m (inclusive) * Subjects must have a negative screen for drugs of abuse, nicotine, alcohol, Hepatitis B, Hepatitis C, and HIV. * Female subjects of child bearing potential must have a negative serum pregnancy test at randomization * Females must be of non-child bearing potential (e.g. postmenopausal) or of childbearing potential and agree to use a highly effective form of contraception from the time of screening to two weeks after last dose of study medication. * Subjects must have normal findings in a physical examination and 12 lead ECG and normal Vital Signs * Clinical laboratory values must be Within Normal limits as defined by the clinical laboratory * Subjects must be able to provide coherent written informed consent * Subjects must be willing and able to follow study instructions and be likely to complete all study requirements. Exclusion Criteria: * History of allergy or sensitivity to oxycodone * History of loud snoring or sleep apnea * History of medical problems encountered with opioid therapy * Urinary cotinine levels indicative of smoking or history of smoking or regular tobacco use with 2 months prior to screening * History of alcoholism or drug abuse * Use of prescription medications within 14 days of study drug administration with exception of contraceptives used by female subjects * Use of any opioid within 30 days prior to screening * History of allergy or sensitivity to naltrexone * History of allergy or sensitivity to naloxone * Donation of blood within 30 days prior to screening * Donation of plasma within 30 days prior to screening * Acute illness at admission of clinical study unit * History of GI disturbance requiring use of antacid twice weekly or more * Females who are breastfeeding * Anticipated need for surgery or hospitalization during the study * Enrollment in an investigational drug study within 30 days prior to screening * Any condition that in the Investigator's opinion puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Part A will utilize a randomized, open label, multiple-ascending dose design with up to 3 separate dose groups of 8 subjects per group.\n\nPart B will utilize an open-label, single-dose, randomized, 4-way crossover design with 13 subjects in each treatment sequence.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 84, 'type': 'ACTUAL'}}

2022-09-19