Healthy VolunteerPhase 1NCT02525484
A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants
A Phase 1 study testing Pirfenidone in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Aug 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Pirfenidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of Pirfenidone
Measured: 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
Measured: 11 days
AUC from Time Zero to Infinity (AUC[0-inf]) of Pirfenidone
Measured: 11 days
Secondary outcomes (4)
Ratio of AUC(0-t) to AUC(0-inf) of Pirfenidone
Measured: 11 days
Terminal Elimination Rate Constant of Pirfenidone
Measured: 11 days
Apparent Terminal Half-Life (t1/2) of Pirfenidone
Measured: 11 days
Time to Peak Plasma Concentration of Pirfenidone
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525484
- Sponsor's protocol ID
- GP29830
- Status last verified
- Nov 2016
- First submitted
- 14 Aug 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02525484
- Acronym / sponsor ID
- GP29830
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone ACBD treatment sequence | Experimental | Drug: PirfenidoneParticipants 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. |
| Pirfenidone BADC treatment sequence | Experimental | Drug: PirfenidoneParticipants 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. |
| Pirfenidone CDAB treatment sequence | Experimental | Drug: PirfenidoneParticipants 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. |
| Pirfenidone DBCA treatment sequence | Experimental | Drug: PirfenidoneParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PirfenidonePirfenidone 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. | Drug | Pirfenidone ACBD treatment sequence, Pirfenidone BADC treatment sequence, Pirfenidone CDAB treatment sequence, Pirfenidone DBCA treatment sequence |
Primary outcome
Peak Plasma Concentration (Cmax) of Pirfenidone
Time frame: 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
Time frame: 11 days
AUC from Time Zero to Infinity (AUC[0-inf]) of Pirfenidone
Time frame: 11 days
4 secondary outcomes
Ratio of AUC(0-t) to AUC(0-inf) of Pirfenidone
Time frame: 11 days
Terminal Elimination Rate Constant of Pirfenidone
Time frame: 11 days
Apparent Terminal Half-Life (t1/2) of Pirfenidone
Time frame: 11 days
Time to Peak Plasma Concentration of Pirfenidone
Time frame: 11 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pirfenidone in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) of Pirfenidone (time frame: 11 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.