Hepatic ImpairmentPhase 1NCT02985632
A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
A Phase 1 study testing BMS-986141 in people with Hepatic Impairment, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- BMS-986141
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jan 2017to 7 Jul 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women not of childbearing potential (WNOCBP), and males, ages 18 to 70 years, inclusive.
- BMI of 20.0 to 38.0 kg/m2 inclusive
- Participants who a history of normal renal function
- Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
- Healthy subjects to the extent possible matched to four subjects with hepatic impairment with regard to body weight, age and gender, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Who cannot join
- Any nonhepatic significant acute or chronic medical illness that could affect participant safety or data interpretation as determined by the investigator.
- History of recurrent dizziness or fall risk within 4 weeks of study drug administration
- History of primarily cholestatic liver diseases, autoimmune liver disease, metastatic liver disease or active alcoholic hepatitis
- History of known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Pharmacology of Miami
Miami, Florida, 33014
Clinical Research Center
Orlando, Florida, 32809
Texas Liver Institute
San Antonio, Texas, 78215
About this study
Official title: Single-dose Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.
- Conditions
- Hepatic Impairment
- Being tested
- BMS-986141
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986141Drug
| Study group | Role | What they receive |
|---|---|---|
| Mild Hepatic Impairment Subjects | Experimental | Subjects given an oral dose of BMS-986141. Receives: Drug: BMS-986141 |
| Moderate Hepatic Impairment Subjects | Experimental | Subjects given an oral dose of BMS-986141. Receives: Drug: BMS-986141 |
| Healthy Subjects | Experimental | Subjects given an oral dose of BMS-986141. Receives: Drug: BMS-986141 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of BMS-986141
Measured: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141
Measured: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141
Measured: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141
Measured: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Secondary outcomes (1)
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation.
Measured: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start11 Jan 2017 (estimated)
- Primary completion18 May 2017 (estimated)
- Study completion7 Jul 2017 (estimated)
Why it stopped: Business objectives have changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985632
- Sponsor's protocol ID
- CV006-030
- Status last verified
- Feb 2017
- First submitted
- 5 Dec 2016
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
- ClinicalTrials.gov ID
- NCT02985632
- Acronym / sponsor ID
- CV006-030
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2017 (estimated)
- Primary completion
- 18 May 2017 (estimated)
- Study completion
- 7 Jul 2017 (estimated)
- First posted
- 7 Dec 2016 (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.
An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Hepatic Impairment Subjects | Experimental | Drug: BMS-986141Subjects given an oral dose of BMS-986141. |
| Moderate Hepatic Impairment Subjects | Experimental | Drug: BMS-986141Subjects given an oral dose of BMS-986141. |
| Healthy Subjects | Experimental | Drug: BMS-986141Subjects given an oral dose of BMS-986141. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women not of childbearing potential (WNOCBP), and males, ages 18 to 70 years, inclusive.
- BMI of 20.0 to 38.0 kg/m2 inclusive
- Participants who a history of normal renal function
- Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
- Healthy subjects to the extent possible matched to four subjects with hepatic impairment with regard to body weight, age and gender, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Key exclusion criteria (5 listed)
- Any nonhepatic significant acute or chronic medical illness that could affect participant safety or data interpretation as determined by the investigator.
- History of recurrent dizziness or fall risk within 4 weeks of study drug administration
- History of primarily cholestatic liver diseases, autoimmune liver disease, metastatic liver disease or active alcoholic hepatitis
- History of known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)
- Other protocol defined 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-986141 | Drug | Healthy Subjects, Mild Hepatic Impairment Subjects, Moderate Hepatic Impairment Subjects |
Primary outcome
Maximum observed plasma concentration (Cmax) of BMS-986141
Time frame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141
Time frame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141
Time frame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141
Time frame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
1 secondary outcome
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation.
Time frame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites 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-986141 in people with Hepatic Impairment, run by Bristol-Myers Squibb at 3 sites 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was withdrawn before enrolling participants, so there are no results.
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 plasma concentration (Cmax) of BMS-986141 (time frame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)). The study lists 4 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 6 Feb 2017.