A Phase 1, Single-Center, Dose-Escalation and Fixed-Dose Crossover, Cohort Study to Determine the Safety and Pharmacokinetics of a Single Oral Dose of PF329 vs oral hydromorphone hydrochloride (HCl) in Healthy Subjects
- Conditions
- PainAnaesthesiology - Pain management
- Registration Number
- ACTRN12610000721000
- Lead Sponsor
- PharmacoFore, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1. Males or females, ages 18-50 years in good general health
2. Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive)
3. Subjects must have a negative screen for drugs of abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and Human Immunodeficiency Virus (HIV)
4. Female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test at randomization
5. Female subjects must use a medically acceptable method of birth control (oral or transdermal contraceptives, condom, spermicidal foam, Intra-Uterine Device (IUD), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner) from the time of screening through two weeks after the last study treatment
6. Subjects must have normal findings in a physical examination and 12-lead Electrocardiogram (ECG), and normal vital signs (respiratory rate between 12 and 20 breaths per minute, blood pressure between 100-140/60-90 mmHg, heart rate between 48-99 beats per minute, temperature between 35.8 degrees Celsius and 37.8 degrees Celsius), and Oxygen Saturation measured by pulse oximetry (SpO2) > 96 percent in the absence of supplemental oxygen.
7. Clinical laboratory values must be within the normal limits as defined by the clinical laboratory, unless the Investigator decides that out-of-range values are not clinically significant
8. Subjects must be able to provide meaningful written informed consent
9. Subjects must be willing and able to follow study instructions and be likely to complete all study requirements
1.History of allergy or sensitivity to hydromorphoneor sulfites
2.History of loud snoring or sleep apnea
3.History of medical problems encountered with opioid therapy
4.Urinary cotinine levels indicative of smoking or history of regular use of tobacco-containing or nicotine-containing products within 2 months prior to screening
5.History of alcoholism or drug abuse (prescription or illicit drugs)
6.Use of prescription or over-the-counter medications within 14 days of study drug administration, except for contraceptive medications used by female subjects
7.Use of any opioid within 30 days prior to screening
8.Donation of blood within 30 days prior to screening
9.Donation of plasma or participation in a plasmapheresis program within 7 days prior to screening
10.Acute illness (e.g., gastrointestinal illness, infection such as influenza, upper respiratory tract infection, or known inflammatory process) at admission to the clinical study unit
11.History of gastrointestinal disturbance requiring frequent use of antacid
12.Anticipated need for surgery or hospitalization during the study
13.Enrollment in an investigational drug study within 30 days prior to screening
14.Any condition, that in the Investigator’s opinion, (i) puts the subject at significant risk, (ii) could confound the study results or (iii) may interfere significantly with the subject’s participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method