A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants

A Phase 1, Two-Part, Open-Label Drug-Drug Interaction Study to Evaluate the Steady State Pharmacokinetics and Safety Following Co-Administration of Nalbuphine Extended-Release Tablets (NAL ER), and Pirfenidone or Nintedanib in Healthy Adult Subjects

The primary purpose of this study is to evaluate the effect of steady-state NAL ER on the pharmacokinetics (PK) of pirfenidone or nintedanib and the effect of steady-state pirfenidone or nintedanib on the PK of NAL ER in healthy participants.

Inclusion Criteria:

• Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m^2) 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).
• History or presence of alcohol or drug abuse.
• Positive urine drug or alcohol results.
• Smoker who has used nicotine containing products within the last 3 months.
• 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 QTc interval.
• Abnormal liver function at Screening or historical or concurrent liver disease.
• Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• Abnormal Estimated glomerular filtration rate (eGFR).
• History of difficulty donating blood or donation of blood or plasma within 56 days of Screening.
• Participation in another clinical study within 30 days of the baseline visit.

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