A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants

NCT02525484 | Completed Phase 1

• 1 other identifier: GP29830
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, open-label, randomized, four-treatment period, four-sequence, single-dose, crossover pharmacokinetic study to determine the bioequivalence of pirfenidone after administration of tablet and capsule dosage forms under both fed and fasted conditions.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax) of Pirfenidone

  11 days

• Area Under the Plasma Concentration Versus Time Curve (AUC) from Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Pirfenidone

  11 days

• AUC from Time Zero to Infinity (AUC[0-inf]) of Pirfenidone

  11 days

Secondary Outcomes (4)

• Ratio of AUC(0-t) to AUC(0-inf) of Pirfenidone

  11 days

• Terminal Elimination Rate Constant of Pirfenidone

  11 days

• Apparent Terminal Half-Life (t1/2) of Pirfenidone

  11 days

• Time to Peak Plasma Concentration of Pirfenidone

  11 days

Study Arms (4)

Pirfenidone ACBD treatment sequence

EXPERIMENTAL

Participants will be given 801 milligrams (mg) single oral doses of pirfenidone on Days 1, 4, 7 and 10 during the study. Participants will be administered, capsules (3 x 267-mg capsule) in fed state (treatment A) on Day 1 and in fasted state (treatment C) on Day 4, 801-mg tablet in fed state (treatment B) on Day 7 and in fasted state (treatment D) on Day 10.

Drug: Pirfenidone

Pirfenidone BADC treatment sequence

EXPERIMENTAL

Participants will be given 801 mg single oral doses of pirfenidone on Days 1, 4, 7 and 10 during the study. Participants will be administered, 801-mg tablet in fed state (treatment B) on Day 1, capsules (3 x 267-mg capsule) in fed state (treatment A) on Day 4, 801-mg tablet in fasted state (treatment D) on Day 7 and capsules (3 x 267-mg capsule) in fasted state (treatment C) on Day 10.

Drug: Pirfenidone

Pirfenidone CDAB treatment sequence

EXPERIMENTAL

Participants will be given 801 mg single oral doses of pirfenidone on Days 1, 4, 7 and 10 during the study. Participants will be administered, capsules (3 x 267-mg capsule) in fasted state (treatment C) on Day 1, 801-mg tablet in fasted state (treatment D) on Day 4, capsules (3 x 267-mg capsule) in fed state (treatment A) on Day 7 and 801-mg tablet in fed state (treatment B) on Day 10.

Drug: Pirfenidone

Pirfenidone DBCA treatment sequence

EXPERIMENTAL

Participants will be given 801 mg single oral doses of pirfenidone on Days 1, 4, 7 and 10 during the study. Participants will be administered, 801-mg tablet in fasted state (treatment D) on Day 1 and in fed state (treatment C) on Day 4, capsules (3 x 267-mg capsule) in fasted state (treatment C) on Day 7 and in fed state (treatment A) on Day 10.

Drug: Pirfenidone

Interventions

Pirfenidone DRUG

Pirfenidone 801 mg single oral doses will be given either in the form of tablet or capsules under fed or fasted conditions on Days 1, 4, 7 and 10.

Pirfenidone ACBD treatment sequence; Pirfenidone BADC treatment sequence; Pirfenidone CDAB treatment sequence; Pirfenidone DBCA treatment sequence

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants between 18 and 55 years of age, inclusive, at the time of screening
• Participants of body mass index of 18.5-30.0 kilograms per square meter (kg/m\^2), inclusive
• Participants of reproductive potential must be willing to use reliable contraceptive methods

You may not qualify if:

• Participants with significant medical history or unstable hepatic, pulmonary, metabolic, neurologic, cardiovascular, gastrointestinal, hematologic, or psychiatric systems, in the opinion of the investigator that may alter the absorption, metabolism, or elimination of study drug
• Participants with calculated creatinine clearance rate less than (\<) 30 milliliters per minute (mL/min) (calculated using the Cockcroft-Gault equation) at screening
• Participants with any use of, or intent to use, medications, including prescription, over-the-counter, herbal preparations, or vitamin/mineral supplementation other than study medications from 14 days before screening through the follow-up telephone call (except for contraception purpose)
• Participants who have received fluvoxamine therapy within 28 days before screening
• Participants who have received any medications known to chronically alter drug absorption, metabolism, or elimination processes within 28 days of screening, or participants who are taking drugs known to affect liver function, in the opinion of the Sponsor or investigator
• Participants who have taken investigative drug and/or device in another clinical study within 28 days or within the investigational drug 5 half-lives, whichever is longer, before screening
• Participants previously dosed in any pirfenidone clinical study
• Participants with any hypersensitivity or idiosyncratic reaction to pirfenidone or the constituents of pirfenidone
• Participants with any elevation of liver test results (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyl transferase \[GGT\], direct bilirubin, or alkaline phosphatase above the upper limit of normal)
• Participants with the following hemoglobin levels at screening: males \< 13.5 grams per deciliter (g/dL), females \< 11.5 g/dL
• Females with a positive serum pregnancy test or who are breastfeeding
• Participants who are seropositive for hepatitis B surface antigen, hepatitis C virus antibodies, or human immunodeficiency (HIV) antibodies at screening
• Participants who have a clinically significant abnormal electrocardiogram (ECG) at screening or a Fridericia corrected QT interval (QTcF) greater than (\>) 500 milliseconds (ms) at screening
• Participants with a plasma donation within 28 days before screening or with a donation of blood or blood products or significant blood loss within 56 days before screening
• Participants with poor venous access

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Merritt Island, Florida, 32953, United States

Location

MeSH Terms

Interventions

pirfenidone

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 17, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)