A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Crossover Multicenter Study to Explore the Safety and Efficacy of Oral PIPE-791 As Treatment in Subjects with Chronic Osteoarthritis Pain (COAP) or Chronic Low Back Pain (CLBP)
The primary goal of this clinical trial is to learn if PIPE-791 is safe and well-tolerated in adults with chronic osteoarthritis pain (COAP) or chronic low back pain (CLBP). The study will also explore whether PIPE-791 lowers pain in people with COAP or CLBP. Subjects will: * Complete a washout period to stop their current pain medications. * Take a daily dose of PIPE-791 or placebo for 4 weeks, then reverse treatment assignment for another 4 weeks. * Record pain levels and track dosing in a daily e-diary. * Visit the clinic for checkups and lab tests throughout the study. * Complete phone assessments during the treatment periods.
• Male or female 18 to 70 years of age, inclusive, at the first Screening visit.
• Only one of the following chronic pain diagnoses at least 6 months prior to Screening:
• Osteoarthritis of the knee OR low back pain (with or without painful lumbosacral radiculopathy)
• Plain radiographs of the knee or lumbar spine consistent with diagnosis within 9 months prior to or during Screening.
• History of related daily pain for at least 6 months prior to Screening.
• Have a body mass index \<40 (inclusive) at Screening.
• Willing to maintain a consistent regimen of any ongoing (stable format and frequency for the duration of study participation) non-pharmacologic pain-relieving therapies.
• Willing to discontinue medications taken for chronic pain conditions and usage of transcutaneous electrical nerve stimulation for the duration of the study.
• Male or female subjects with reproductive potential agree to comply with a highly effective contraceptive method as per protocol through 90 days after last study drug administration.
• Subjects taking systemic hormone-replacement therapy must be on a stable dose and regimen for at least 1 month prior to Screening.
• General good medical health with no clinically significant or relevant abnormalities except those attributed to the underlying chronic pain condition, including medical history, physical exam, vital signs, ECG, and laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigator.
• Ability to use an eDiary to record daily pain scores.