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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTrevi Therapeutics

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m2) at Screening.

Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.

Disqualifiers

Positive results for coronavirus infection (COVID-19) at Screening or check-in (Day -1).

History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.

Positive urine drug or alcohol results at Screening or check in (Day -1).

Smoker who has smoked or used nicotine containing products within the last 3 months prior to the first dose and throughout the study, confirmed by a negative cotinine test at Screening and check-in (Day -1).

Trial design

Design model

Crossover

Treatments tested in this trial

  • NAL ER

    Drug

    Oral tablets

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cohort 1: NAL ER Dose AExperimental treatment 1 intervention
Group B: Cohort 2: NAL ER Dose BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Relative Bioavailability of NAL ER

Time frame
Predose and at multiple timepoints postdose (from Day 1 to Day 8)

Secondary outcomes

1

Maximum Plasma Concentration (Cmax) of NAL ER

Time frame
Predose and at multiple timepoints postdose (from Day 1 to Day 8)
2

Time to Reach Maximum Observed Concentration (Tmax) of NAL ER

Time frame
Predose and at multiple timepoints postdose (from Day 1 to Day 8)
3

Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER

Time frame
Predose and at multiple timepoints postdose (from Day 1 to Day 8)
4

Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER

Time frame
Predose and at multiple timepoints postdose (from Day 1 to Day 8)

Other outcomes

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