Idiopathic Pulmonary FibrosisPhase 1NCT05428150
Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers
A Phase 1 study testing Esbriet 267 MG Oral Capsule and EXCL-100, 600 MG Oral Tablet in people with Idiopathic Pulmonary Fibrosis, run by Excalibur Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a randomized, open-label, 2-treatment, 2-period, crossover steady state study conducted to evaluate the comparative bioavailability/bioequivalence of pirfenidone after multi-dose administration of EXCL-100 at doses of 1200 mg (600 mg x 2) in the fed state, and Esbriet® 801 mg (267 mg capsule x 3) given in the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Esbriet 267 MG Oral Capsule and EXCL-100, 600 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2022to 25 Sep 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a male or female aged 18 to 65 years inclusive with a body mass index at time of screening between 18 and 32 kg/m2.
- Subject is in good health, as determined by the investigator, as documented by the medical history, physical examination, vital sign assessment, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations.
- Abnormalities or deviations outside the normal ranges for any clinical assessments (laboratory tests, ECG, vital signs) may be repeated once during the screening period at the discretion of the Investigator(s), and results that continue to be outside the normal ranges must be judged by the investigator to be not clinically significant and acceptable for study participation.
- At Screening, ALT, AST, and total bilirubin values must be ≤ 1.5 times the upper limit of normal (ULN).
- All other laboratory test results that are outside the normal range at Screening and judged by the investigator to be not clinically significant, may be repeated. Results that continue to be outside the normal range must be judged by the investigator to be not clinically significant and acceptable for study participation.
- Male and female
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- Female subjects of childbearing potential who are not pregnant as confirmed by a negative serum pregnancy test at Screening and urine pregnancy test on Day -1 of Period 1, non-lactating, using effective methods of contraception for a minimum of one complete menstrual cycle prior to the Screening visit and agree to continue using until 30 days after the last dose of study drug. Effective methods of birth control include: Hormonal methods of contraception including oral contraceptives containing combined estrogen and progesterone, a vaginal ring, injectable and implantable hormonal contraceptives, intrauterine hormone-releasing system (eg, Mirena) and progestogen-only hormonal contraception associated with inhibition of ovulation, nonhormonal intrauterine device (IUD), bilateral tubal occlusion, or vasectomized partner, if that partner is the sole sexual partner.
- Female subjects of non-childbearing potential must be surgically sterile (e.g., hysterectomy, bilateral tubal ligation, bilateral salphingectomy and/or bilateral oophorectomy) or post-menopausal (no menses for >1 year with follicle stimulating hormone [FSH] in the post-menopausal range at screening, based on the central laboratory's range).
- Female subject must not donate eggs during the study and for at least 30 days after the last dose of study drug.
- Male subjects who have not had a vasectomy must agree to use an effective method of contraception (condom with spermicide) during the study and until 90 days after the last dose of the study drug, and to not donate sperm during the study and for at least 90 days after the last dose of study drug.
- Subject is willing to remain in the study facility for the duration of the confinement periods.
- Subject is able to communicate with the investigator and is willing to comply with the requirements of the entire study.
- Subject understands and signs the informed consent form.
Who cannot join
- History or presence of clinically significant (CS) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychiatric, or other major disease, as determined by the Investigator.
- Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the drug.
- History of severe allergic or anaphylactic reactions.
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C virus antibody (HCV), or positive human immunodeficiency virus (HIV) test result at Screening.
- A positive result on SARS-CoV-2 (COVID-19) tests assessed by rapid antigen testing (RAT) at Day -1 of Period 1.
- History of alcohol abuse or illicit drug use within 1 year of Screening or consumption of alcohol greater than 21 units per week. A unit of alcohol is equivalent to 1 can of beer, 1 glass of wine, or the equivalent of 1 alcoholic drink.
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- A positive urine drug or breath alcohol test result at Screening or Day -1 of Period 1.
- Smoking and the use of nicotine-containing products (including nicotine patches, gum, inhalers, and e-cigarettes) within 6 months of the Screening visit or positive urine cotinine tests at Screening or Day -1 of Period 1) and inability to refrain from nicotine from Screening until the end of the study.
- Standard donation of blood or blood products within 30 days of Day-1 of Period 1 .
- Use of any investigational drug within 30 days of Day-1 of Period 1 .
- Participants previously dosed in any pirfenidone clinical study.
- Use of CYP1A2 inhibitors (e.g., enoxacin, ciprofloxacin) or CYP1A2 inducers within 14 days prior to screening and for the duration of the study.
- Participants who have received fluvoxamine therapy within 28 days before screening.
- Need for concomitant prescription medications, except for birth control and hormone replacement therapy, starting 14 days or 5 half-lives before dosing (Day 1 of Period 1), whichever is longer, through the completion of all study procedures, or subject needs an over the counter (OTC) medication including other herbal supplements or multivitamins, starting 7 days before dosing (Day 1 of Period 1) through the completion of all study procedures. Up to 2 grams per day of acetaminophen is allowed at the discretion of the PI.
- Regular caffeine consumption of greater than 300 mg/day. Inability to restrict consumption of caffeine to less than 300 mg/day (2 standard cups brewed coffee) during the study.
- Seated blood pressure was less than 90/40 mmHg or greater than 140/90 mmHg at screening. (After being seated for at least 5 minutes). Measurements can be repeated once to determine eligibility.
- Heart rate was less than 40 bpm or great than 99 bpm at screening. (After being seated for at least 5 minutes). Measurements can be repeated once to determine eligibility.
- Participants with calculated creatinine clearance rate less than (<) 60 milliliters per min (mL/min) (calculated using the CKD-EPI equation) at screening.
- Any clinically significant ECG abnormality at screening (as deemed by the Investigator and the Sponsor's Medical Monitor).
- QTcF interval > 450 msec (the average value for the triplicate ECG at Screening and Day -1 of Period 1), or history of prolonged QT syndrome.
- Other unspecified reasons that, in the opinion of the PI or Sponsor, make the subject unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227
About this study
Official title: Randomized, Crossover, Multi-Dose, Steady State, Comparative Pharmacokinetics and Relative Bioavailability Study of EXCL-100 Pirfenidone-Sustained Release Tablet (EXCL-100), and Esbriet® in Healthy Volunteers
This is a randomized, open-label, 2-treatment, 2-period, crossover steady state study conducted to evaluate the comparative bioavailability/bioequivalence of pirfenidone after multi-dose administration of EXCL-100 at doses of 1200 mg (600 mg x 2) in the fed state, and Esbriet® 801 mg (267 mg capsule x 3) given in the fed state, to healthy volunteers.
Read the detailed description
After signing the Institutional Review Board (IRB) approved Informed Consent Form (ICF), subjects will undergo a screening evaluation up to 28 days prior to dosing on Day 1 of Period 1. Subjects who satisfy the screening evaluation and who meet the inclusion and exclusion criteria will be enrolled in the study. Subjects will receive multiple doses of study drug according to their assigned sequence of treatment in Period 1. After completion of study procedures, a washout period will be completed prior to crossover to Period 2 to receive the second treatment in their sequence. Subjects will receive Regimens A (Esbriet® 801 mg three times daily with meals for 3 days) and B (EXCL-100, 1200 mg twice daily with meals) according to the randomization schedule. Pharmacokinetic (PK) blood samples will be taken on multiple days during the study periods.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Esbriet 267 MG Oral Capsule, EXCL-100, 600 MG Oral Tablet
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esbriet 267 MG Oral CapsuleDrug
Reference Formulation
EXCL-100, 600 MG Oral TabletDrug
Test Formulation
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Active comparator | Esbriet® 801 mg (267 mg oral capsule x 3), three times daily (TID) with meals (6 hours apart) for 3 days, total daily dose of 2403 mg, given under fed conditions. Subjects will receive a single dose on Day 4 after breakfast. Receives: Drug: Esbriet 267 MG Oral Capsule |
| Regimen B | Experimental | EXCL-100, 1200 mg (600 mg oral tablet x 2), twice daily with meals (BID, every 12 hours) for 3 days, total daily dose of 2400 mg, given under fed conditions. Subjects will receive a single dose on Day 4 after breakfast. Receives: Drug: EXCL-100, 600 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-inf
Area under plasma concentration-time curve from time 0 to infinity for pirfenidone and 5-carboxy pirfenidone
Measured: Up to Day 6 of Periods 1 and 2
Secondary outcomes (4)
AUC 0-24ss
Area under plasma concentration-time curve from time 0 to 24 hours for pirfenidone and 5-carboxy pirfenidone
Measured: Day 3 of Periods 1 and 2
AUC last
Time 0 to the time of the last quantifiable plasma concentration for pirfenidone and 5-carboxy pirfenidone
Measured: Up to Day 6 of Periods 1 and 2
C max
Observed maximum concentration for pirfenidone and 5-carboxy pirfenidone
Measured: Up to Day 6 of Periods 1 and 2
Safety and Tolerability
Adverse Events reported
Measured: From Day 1 of Period 1 through study completion (an average of 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start8 Aug 2022
- Primary completion25 Sep 2022
- Study completion25 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Excalibur Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renu Gupta, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428150
- Sponsor's protocol ID
- EXCL-100-102
- Status last verified
- Nov 2022
- First submitted
- 15 Jun 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Crossover, Multi-Dose, Steady State, Comparative Pharmacokinetics and Relative Bioavailability Study of EXCL-100 Pirfenidone-Sustained Release Tablet (EXCL-100), and Esbriet® in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05428150
- Acronym / sponsor ID
- EXCL-100-102
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Excalibur Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 25 Sep 2022 (actual)
- Study completion
- 25 Sep 2022 (actual)
- First posted
- 22 Jun 2022 (actual)
- 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 randomized, open-label, 2-treatment, 2-period, crossover steady state study conducted to evaluate the comparative bioavailability/bioequivalence of pirfenidone after multi-dose administration of EXCL-100 at doses of 1200 mg (600 mg x 2) in the fed state, and Esbriet® 801 mg (267 mg capsule x 3) given in the fed state, to healthy volunteers.
Detailed description
After signing the Institutional Review Board (IRB) approved Informed Consent Form (ICF), subjects will undergo a screening evaluation up to 28 days prior to dosing on Day 1 of Period 1. Subjects who satisfy the screening evaluation and who meet the inclusion and exclusion criteria will be enrolled in the study. Subjects will receive multiple doses of study drug according to their assigned sequence of treatment in Period 1. After completion of study procedures, a washout period will be completed prior to crossover to Period 2 to receive the second treatment in their sequence. Subjects will receive Regimens A (Esbriet® 801 mg three times daily with meals for 3 days) and B (EXCL-100, 1200 mg twice daily with meals) according to the randomization schedule. Pharmacokinetic (PK) blood samples will be taken on multiple days during the study periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Active comparator | Drug: Esbriet 267 MG Oral CapsuleEsbriet® 801 mg (267 mg oral capsule x 3), three times daily (TID) with meals (6 hours apart) for 3 days, total daily dose of 2403 mg, given under fed conditions. Subjects will receive a single dose on Day 4 after breakfast. |
| Regimen B | Experimental | Drug: EXCL-100, 600 MG Oral TabletEXCL-100, 1200 mg (600 mg oral tablet x 2), twice daily with meals (BID, every 12 hours) for 3 days, total daily dose of 2400 mg, given under fed conditions. Subjects will receive a single dose on Day 4 after breakfast. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is a male or female aged 18 to 65 years inclusive with a body mass index at time of screening between 18 and 32 kg/m2.
- Subject is in good health, as determined by the investigator, as documented by the medical history, physical examination, vital sign assessment, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations.
- Male and female
- Subject is willing to remain in the study facility for the duration of the confinement periods.
- Subject is able to communicate with the investigator and is willing to comply with the requirements of the entire study.
Key exclusion criteria (21 listed)
- History or presence of clinically significant (CS) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychiatric, or other major disease, as determined by the Investigator.
- Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the drug.
- History of severe allergic or anaphylactic reactions.
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C virus antibody (HCV), or positive human immunodeficiency virus (HIV) test result at Screening.
- A positive result on SARS-CoV-2 (COVID-19) tests assessed by rapid antigen testing (RAT) at Day -1 of Period 1.
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 |
|---|---|---|
| Esbriet 267 MG Oral CapsuleReference Formulation | Drug | Regimen A |
| EXCL-100, 600 MG Oral TabletTest Formulation | Drug | Regimen B |
Primary outcome
AUC 0-inf
Time frame: Up to Day 6 of Periods 1 and 2
Area under plasma concentration-time curve from time 0 to infinity for pirfenidone and 5-carboxy pirfenidone
4 secondary outcomes
AUC 0-24ss
Time frame: Day 3 of Periods 1 and 2
AUC last
Time frame: Up to Day 6 of Periods 1 and 2
C max
Time frame: Up to Day 6 of Periods 1 and 2
Safety and Tolerability
Time frame: From Day 1 of Period 1 through study completion (an average of 15 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 14 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Renu Gupta, MD study director
Chief Medical Officer
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 Esbriet 267 MG Oral Capsule and EXCL-100, 600 MG Oral Tablet in people with Idiopathic Pulmonary Fibrosis, run by Excalibur Pharmaceuticals, Inc. 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 13 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 14 Nov 2022. 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?
AUC 0-inf (time frame: Up to Day 6 of Periods 1 and 2). 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 14 Nov 2022.