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

Healthy Volunteer Clinical Trial

Official title:

A Phase I, Open-Label, Randomized, Four-Treatment Period, Four-Sequence, Single-Dose, Crossover, Pharmacokinetic Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525484
• Other study ID #: GP29830
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2015
• Last updated: November 1, 2016
• Start date: August 2015
• Est. completion date: August 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Participants who have used cigarettes (including vapor cigarettes), cigars, and nicotine-containing products within 3 months before screening or plan to use them through completion of the follow-up telephone call

• Participants with a history of alcoholism or drug abuse, per discretion of the investigator, within 2 years of screening or a positive qualitative drug screen for drugs of abuse at screening or Day -1

• Participants who have not withheld alcoholic beverages/alcohol-containing products or caffeinated beverages/caffeine- or xanthine-containing products at least 72 hours before first study dose administration or who plan to consume them during the study or a positive qualitative drug screen for alcohol at screening or Day -1

• Participants with an abnormal diet (as determined by the investigator) within the 28 days before first study dose administration

• Participants who have not withheld consuming cruciferous vegetables (broccoli, kale, Brussels sprouts), grapefruit or grapefruit juice, or chargrilled meat 48 hours before dosing or who plan to consume them during the study

• Participants who cannot refrain from strenuous exercise from 48 hours before first study dose administration through completion of the study

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Pirfenidone
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax) of Pirfenidone		11 days	No
Primary	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	No
Primary	AUC from Time Zero to Infinity (AUC[0-inf]) of Pirfenidone		11 days	No
Secondary	Ratio of AUC(0-t) to AUC(0-inf) of Pirfenidone		11 days	No
Secondary	Terminal Elimination Rate Constant of Pirfenidone		11 days	No
Secondary	Apparent Terminal Half-Life (t1/2) of Pirfenidone		11 days	No
Secondary	Time to Peak Plasma Concentration of Pirfenidone		11 days	No