Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201) (NCT06629402) | Clinical Trial Compass
CompletedPhase 2
Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)
United States16 participantsStarted 2023-10-05
Plain-language summary
The primary objective of the study is to evaluate the onset of analgesia following administration of a single oral dose of PF614 (50 mg or 100 mg) or placebo in healthy male subjects in an experimental pain model (cold pressor test \[CPT\]).
Who can participate
Age range18 Years – 55 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Non-smoking males, ages 18-55 years, inclusive, in good general health.
✓. Body mass index (BMI) within the range of 18.0 to 34.0 kg/m2, inclusive, and a minimum weight of 50.0 kg.
✓. Subjects must have completed at least 2 CPTs at Screening (minimum 30 minutes apart or when the dorsal surface hand skin temperature had returned to baseline temperature \[±2°C\]), with both tests resulting in latency time of greater than 20 seconds and less than 120 seconds.
✓. Subjects must have had prior therapeutic experience with use of opioids for analgesia without showing signs of opioid-induced vomiting, dysphoria, or clinically significant sedation.
✓. Subjects must have agreed to use a double-barrier contraceptive method (condom and spermicide, or condom along with female partner's contraceptive method \[oral, injectable, implanted, transdermal, or intrauterine device (IUD) with or without hormones\]), or at least one partner was confirmed to be surgically sterile, or subject must have agreed to remain abstinent from heterosexual intercourse at the time of Screening, during the study, and for 90 days following the last administration of study drug. Subjects must have agreed to not donate sperm during the study and for 90 days following the last administration of study drug.
✓. Subjects must have been able to speak, read, and understand English sufficiently to allow completion of all study assessments.
✓. Subjects must have been able to provide written informed consent.
✓. Subjects must have been willing and able to follow study instructions and been likely to complete all study requirements.
Exclusion criteria
What they're measuring
1
Change from Baseline (pre-dose) in Time to Pain Onset (defined as time to first pain)
Timeframe: 6 hours
2
Change from Baseline in Pain Tolerance (defined as latency time required for removal of hand from water bath)
✕. Lifetime history or presence of substance or alcohol use disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition, Text Revision (DSM-V-TR).
✕. History or presence of clinically significant abnormality, as assessed by physical examination, medical history, electrocardiograms (ECGs), vital signs, or laboratory values, which, in the opinion of an investigator, would have jeopardized the safety of the subject or the validity of the study results. Retesting may have been permitted at the discretion of an investigator.
✕. History or presence of acute respiratory depression, chronic pulmonary disease, cor pulmonale, delirium tremens, central nervous system (CNS) depression, or increased cerebrospinal or intracranial pressure.
✕. History or presence of peripheral neuropathy or significant trauma or injury to non-dominant hand.
✕. Documented history of, or currently active, seizure disorder (excluding febrile seizures in childhood), history of clinically significant head injury or syncope of unknown origin.
✕. History or presence of obstructive sleep apnea.
✕. History of gastrointestinal disturbance requiring frequent use of antacids.
✕. History of or presence of trypsin deficiency.