A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants

Part of paid clinical trials in Miami, Florida.

Sponsor
Trevi Therapeutics
Study ID
NCT07487740
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • NAL ER — DRUG
    Oral tablets

Study Details

The primary purpose of this study is to evaluate the effect of a high-fat, high-calorie meal on the relative bioavailability of NAL ER following single oral doses.

Key Dates

Start date
Feb 27, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: NAL ER Dose A
    Participants will receive NAL ER Dose A on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences.
  • Experimental: Cohort 2: NAL ER Dose B
    Participants will receive NAL ER Dose B on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences.

Primary Outcome Measure

Relative Bioavailability of NAL ER [ Time Frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of Miami, LLC.MiamiFlorida33172
Hadaza Catala
[email protected]
305-817-2900

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By research site
Clinical Pharmacology of Miami, LLC.· Miami, FL

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