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

Official title

A Randomized, Phase 1, Open-Label, Two-Treatment, Two- Period, Two-Sequence, Single-Dose Crossover Study to Evaluate the Effect of Food on the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Subjects

Overview

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.

Interventions

• Drug NAL ER
  Oral tablets

Primary outcome measures

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

Secondary outcome measures (7)

• Maximum Plasma Concentration (Cmax) of NAL ER [Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)]
• Time to Reach Maximum Observed Concentration (Tmax) of NAL ER [Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)]
• 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)]
• 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)]
• Apparent Terminal Rate Constant (λz) of NAL ER [Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)]
• Apparent Terminal Half-Life (t1/2) of NAL ER [Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)]
• Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to Day 18]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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).
• History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
• Hemoglobin, absolute neutrophil count, or platelet levels outside of the reference range at Screening.
• History of prolonged QT syndrome or a corrected QT (QTc) interval.
• Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• Participation in another clinical study within 5 half-lives or 30 days, whichever is longer, of the Baseline visit.

Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Clinical Pharmacology of Miami, LLC. — Miami

Identifiers

NCT: NCT07487740 · NAL00-107

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗