Idiopathic Pulmonary Fibrosis (IPF)Phase 1NCT03981094
A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants
A Phase 1 study testing BMS-986278 and Pirfenidone in people with Idiopathic Pulmonary Fibrosis (IPF), run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The main objectives of this study are to characterize the PK of BMS-986278 after administration of a single dose of BMS-986278 alone or in combination with pirfenidone, as well as to characterize the PK of pirfenidone after administration of a single dose of pirfenidone alone or in combination with BMS-986278 Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- BMS-986278 and Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 30 Jul 2019
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent.
- Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
Who cannot join
- Women of child bearing potentia (WOCBP), pregnant or breastfeeding.
- History of significant cardiovascular disease.
- Participants who have smoked or used smoking cessation or nicotine containing products within 3 months of the first dose of study.
- Other protocol defined inclusion/exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
PRA Health Sciences - Salt Lake
Salt Lake City, Utah, 84124
About this study
Official title: An Open Label Study to Assess the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 Following a Single Oral Dose Administration in Healthy Participants
The main objectives of this study are to characterize the PK of BMS-986278 after administration of a single dose of BMS-986278 alone or in combination with pirfenidone, as well as to characterize the PK of pirfenidone after administration of a single dose of pirfenidone alone or in combination with BMS-986278
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- BMS-986278, Pirfenidone
- 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.
BMS-986278Drug
suspension
PirfenidoneDrug
capsule
| Study group | Role | What they receive |
|---|---|---|
| BMS-986278 | Experimental | Not described Receives: Drug: BMS-986278 |
| Pirfenidone | Experimental | Not described Receives: Drug: Pirfenidone |
| BMS-986278 + Pirfenidone | Experimental | Not described Receives: Drug: BMS-986278; Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination
Measured: Up to day 5 of each period (Each period is 7 days; 3 periods total)
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986278 and pirfenidone alone or in combinaton
Measured: Up to day 5 of each period (Each period is 7 days; 3 periods total)
Area under the plasma concentration-time curve extrapolated to infinity [(AUC(INF)] of BMS-986278 and pirfenidone alone or in combinaton
Measured: Up to day 5 of each period (Each period is 7 days; 3 periods total)
Secondary outcomes (15)
Incidence of AEs (adverse events), SAEs (serious adverse events), and AEs leading to discontinuation
Measured: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Number of Participants With Clinically Significant Change in Clinical Laboratory Values
Measured: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Number of Participants With Clinically Significant Change in Vital Signs
Measured: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)
Measured: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Number of Participants With Clinically Significant Change in Physical Examination
Measured: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Volume of distribution at terminal phase (VzF) of BMS-986278 and metabolite alone or in combination with pirfenidone
Measured: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
Time of maximum observed serum concentration (Tmax) of BMS-986278 and metabolite alone or in combination with pirfenidone
Measured: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
Elimination half-life (T-HALF) of BMS-986278 and metabolite alone or in combination with pirfenidone
Measured: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
Oral clearance (CL/F) of BMS-986278 and metabolite alone or in combination with pirfenidone
Measured: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
Time of maximum observed serum concentration (Tmax) of pirfenidone and metabolite alone or in combination with BMS-986278
Measured: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Elimination half-life (T-HALF) of pirfenidone and metabolite alone or in combination with BMS-986278
Measured: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Oral clearance (CL/F) of pirfenidone and metabolite alone or in combination with BMS-986278
Measured: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Volume of distribution at terminal phase (VzF) Plasma Pharmokinetics of pirfenidone and metabolite alone or in combination with BMS-986278
Measured: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Renal clearance (Clr) in Urine of pirfenidone alone or in combination with BMS-986278
Measured: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Cumulative amount recovered in urine [Ae(0-T)] of pirfenidone alone or in combination with BMS-986278
Measured: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start10 May 2019
- Primary completion27 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will be conducted in three periods, so that all the randomized participants receive treatment (participants receive pirfenidone only, or BMS-986278 only, or both together during each treatment period).
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981094
- Sponsor's protocol ID
- IM027-041
- Status last verified
- May 2020
- First submitted
- 21 May 2019
- Last updated
- 15 May 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Assess the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 Following a Single Oral Dose Administration in Healthy Participants
- ClinicalTrials.gov ID
- NCT03981094
- Acronym / sponsor ID
- IM027-041
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 10 May 2019 (actual)
- Primary completion
- 27 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 10 Jun 2019 (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.
The main objectives of this study are to characterize the PK of BMS-986278 after administration of a single dose of BMS-986278 alone or in combination with pirfenidone, as well as to characterize the PK of pirfenidone after administration of a single dose of pirfenidone alone or in combination with BMS-986278
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will be conducted in three periods, so that all the randomized participants receive treatment (participants receive pirfenidone only, or BMS-986278 only, or both together during each treatment period).
| Arm | Type | Receives |
|---|---|---|
| BMS-986278 | Experimental | Drug: BMS-986278 |
| Pirfenidone | Experimental | Drug: Pirfenidone |
| BMS-986278 + Pirfenidone | Experimental | Drug: BMS-986278, Drug: Pirfenidone |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed Informed Consent.
- Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
Key exclusion criteria (4 listed)
- Women of child bearing potentia (WOCBP), pregnant or breastfeeding.
- History of significant cardiovascular disease.
- Participants who have smoked or used smoking cessation or nicotine containing products within 3 months of the first dose of study.
- Other protocol defined inclusion/exclusion criteria could apply.
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 |
|---|---|---|
| BMS-986278suspension | Drug | BMS-986278, BMS-986278 + Pirfenidone |
| Pirfenidonecapsule | Drug | BMS-986278 + Pirfenidone, Pirfenidone |
Primary outcome
Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination
Time frame: Up to day 5 of each period (Each period is 7 days; 3 periods total)
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986278 and pirfenidone alone or in combinaton
Time frame: Up to day 5 of each period (Each period is 7 days; 3 periods total)
Area under the plasma concentration-time curve extrapolated to infinity [(AUC(INF)] of BMS-986278 and pirfenidone alone or in combinaton
Time frame: Up to day 5 of each period (Each period is 7 days; 3 periods total)
15 secondary outcomes
Incidence of AEs (adverse events), SAEs (serious adverse events), and AEs leading to discontinuation
Time frame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Number of Participants With Clinically Significant Change in Clinical Laboratory Values
Time frame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Number of Participants With Clinically Significant Change in Vital Signs
Time frame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)
Time frame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Number of Participants With Clinically Significant Change in Physical Examination
Time frame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Volume of distribution at terminal phase (VzF) of BMS-986278 and metabolite alone or in combination with pirfenidone
Time frame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
Time of maximum observed serum concentration (Tmax) of BMS-986278 and metabolite alone or in combination with pirfenidone
Time frame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
Elimination half-life (T-HALF) of BMS-986278 and metabolite alone or in combination with pirfenidone
Time frame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
Oral clearance (CL/F) of BMS-986278 and metabolite alone or in combination with pirfenidone
Time frame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
Time of maximum observed serum concentration (Tmax) of pirfenidone and metabolite alone or in combination with BMS-986278
Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Elimination half-life (T-HALF) of pirfenidone and metabolite alone or in combination with BMS-986278
Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Oral clearance (CL/F) of pirfenidone and metabolite alone or in combination with BMS-986278
Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Volume of distribution at terminal phase (VzF) Plasma Pharmokinetics of pirfenidone and metabolite alone or in combination with BMS-986278
Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Renal clearance (Clr) in Urine of pirfenidone alone or in combination with BMS-986278
Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Cumulative amount recovered in urine [Ae(0-T)] of pirfenidone alone or in combination with BMS-986278
Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
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 15 May 2020.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BMS-986278 and Pirfenidone in people with Idiopathic Pulmonary Fibrosis (IPF), run by Bristol-Myers Squibb 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 2 inclusion and 4 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 15 May 2020. 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?
Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination (time frame: Up to day 5 of each period (Each period is 7 days; 3 periods total)). 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 15 May 2020.