A Clinical Trial of GRT7040 in Adults With Acute Pain Following Bunionectomy

This is a randomized, double-blind, double-dummy, placebo- and active controlled, 2-part Phase 2 trial.

In Part A, there will be three trial arms. In Part B there will be five trial arms.

The trial duration for Parts A and B will be approximately 6 weeks (notwithstanding visit windows) consisting of a Screening Period (up to 28 Days), randomization and IMP administration on Day 1, followed by a 48 h of Treatment Period, and a 10-day Safety Follow-up (SFU) Period.

Excluding the Screening Period, each participant will participate in the trial for approximately 13 (± 2) days (from Day 1 to the End-of-Trial [EoT] Visit).

Screening will occur within 28 days before administration of the IMP. Informed consent will be obtained prior to performing any trial-related procedures or assessments.

Inclusion criteria

• Adults scheduled for a primary unilateral bunionectomy with distal first metatarsal osteotomy and internal fixation under regional anesthesia.
• Able and willing to provide informed consent and comply with study procedures.
• Body weight ≥50 kg and BMI 18 to 40 kg/m².
• Medically fit for surgery and study treatment based on medical history, physical examination, ECG, vital signs, and laboratory assessments.
• Meets protocol-specified contraception requirements.
• After surgery, reports moderate to severe pain (Verbal Rating Scale) with a Numeric Pain Rating Scale (NPRS) score ≥4 within 9 hours after removal of the popliteal sciatic block.
• Able to follow commands and has complied with protocol-required perioperative analgesic guidelines.

Exclusion criteria

• Clinically significant medical conditions or laboratory abnormalities that could increase risk or interfere with study assessments.
• Major surgery within 6 months prior to screening or anticipated need for major surgery during the study.
• Prior bunionectomy or related surgery on either applicable foot.
• Peripheral neuropathy affecting the legs.
• Clinically significant cardiac disease, arrhythmias, QT prolongation risk, or abnormal ECG findings.
• Sleep apnea requiring positive airway pressure therapy.
• American Society of Anesthesiologists (ASA) physical status classification ≥3.
• Contraindication, intolerance, allergy, or unwillingness to receive study-related analgesics, NSAIDs, acetaminophen/hydrocodone, local anesthetics, or study drug components.
• Participation in another interventional clinical trial within the protocol-defined exclusion period.
• Significant renal impairment, hepatic impairment, positive HIV, hepatitis B, or hepatitis C tests.
• History of substance abuse or addiction within the previous 3 years or positive drug/alcohol screening as specified by the protocol.
• Blood or plasma donation exceeding protocol limits before screening.
• Pregnant, breastfeeding, planning pregnancy during the study, or unwilling to comply with contraception requirements.
• Postoperative factors precluding randomization, including unsuccessful popliteal block placement, surgical complications, non-adherence to postoperative analgesic requirements, or medical complications during surgery.