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

Trevi Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Nintedanib; Drug: Pirfenidone; Drug: NAL ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT07015398

NAL00-105

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.]

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 4 patient groups

Cohort A1 - NAL ER + Pirfenidone

Experimental group

Description:

Participants will receive NAL ER followed by NAL ER co-administered with pirfenidone.

Treatment:

Drug: NAL ER

Drug: Pirfenidone

Cohort A2 - NAL ER + Nintedanib

Experimental group

Description:

Participants will receive NAL ER followed by NAL ER co-administered with nintedanib.

Treatment:

Drug: NAL ER

Drug: Nintedanib

Cohort B1 - Pirfenidone + NAL ER

Experimental group

Description:

Participants will receive pirfenidone followed by pirfenidone co-administered with NAL ER.

Treatment:

Drug: NAL ER

Drug: Pirfenidone

Cohort B2 - Nintedanib + NAL ER

Experimental group

Description:

Participants will receive nintedanib followed by nintedanib co-administered with NAL ER.

Treatment:

Drug: NAL ER

Drug: Nintedanib