NAL ER IPF Respiratory Function and Safety Study
Research type
Research Study
Full title
A Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Potential Modification of Respiratory Physiology of Escalating Doses of Nalbuphine Extended-Release Tablets (NAL ER) in Patients with Idiopathic Pulmonary Fibrosis (IPF)
IRAS ID
1008722
Contact name
Katherine Takaki
Contact email
Sponsor organisation
Trevi Therapeutics Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to assess the safety, tolerability & effects on breathing of increasing doses of an oral nalbuphine extended-release tablet (NAL ER), in patients with Idiopathic Pulmonary Fibrosis (IPF). The active ingredient, nalbuphine, binds to certain receptors in the brain and lungs, and may play a role in the cough reflex. Nalbuphine is currently only available as a generic medication in an injectable form. NAL ER is being developed as a potential treatment for the cough associated with IPF.\nThis is a single-blind study; patients will not be made aware whether they receive the study drug or placebo. The sponsor and investigators will know this information.\nAfter attending a Screening Visit, patients will be admitted to the clinical unit for a 48-hour Baseline Visit. On Day 1, eligible patients will remain in the unit and be randomised to receive twice daily increasing doses of NAL ER or placebo, over 8 days. Patients will remain admitted until Day 10. Two follow-up phone calls will be performed approx. 7 and 14 days after the last dose.\nInitially, a sentinel group of 4 patients will be enrolled. Once a Safety Monitoring Committee (SMC) has reviewed the sentinel data (up to Day 10), a decision will be made whether to continue to randomise a further 8 patients, with the possibility that the sponsor may choose to randomise up to 20.\nIPF patients who also have a diagnosis of Obstructive Sleep Apnoea (OSA) will be eligible to participate in the Screening and Baseline Visits but are not eligible to progress into the Treatment Phase. Following a SMC review, the protocol may be amended in the future to also allow IPF patients with OSA to participate.\nAssessments performed during the study include a chest x-ray, blood & urine samples, vital signs, physical examinations, ECGs, cough monitoring, respiratory monitoring, spirometry & capnography breathing tests, and questionnaires.\nThis study will take place in up to 4 study sites, across the UK and USA.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0042
Date of REC Opinion
29 May 2024
REC opinion
Further Information Favourable Opinion