Hepatitis CPhase 1NCT01886599
Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease
A Phase 1 study testing Asunaprevir in people with Hepatitis C, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Asunaprevir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2012to Feb 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group A: Subjects with normal renal function
- Group B: Patients with end stage renal disease
- Group C: Patients with mild renal impairment
- Group D: Patients with moderate renal impairment
- Group E: Patients with severe renal impairment
Who cannot join
- History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease
- Hepatitis B or C
- Human Immunodeficiency Virus (HIV)
- Recent gastrointestinal disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Orleans Center For Clinical Research
Knoxville, Tennessee, 37920
Davita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: Open-Label, Parallel Group, Multiple-Dose Study to Evaluate the Pharmacokinetics and Safety of Asunaprevir in Subjects With Renal Function Impairment
The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function
Read the detailed description
Primary Purpose:
Other: The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function
- Conditions
- Hepatitis C
- Being tested
- Asunaprevir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsunaprevirDrug
Also called BMS-650032
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Subjects with normal renal function | Experimental | Asunaprevir 100 mg tablet by mouth twice daily for 7 days Receives: Drug: Asunaprevir |
| Arm B: Subjects with end stage renal disease | Experimental | Asunaprevir 100 mg tablet by mouth twice daily for 7 days Receives: Drug: Asunaprevir |
| Arm C: Subjects with mild renal impairment | Experimental | Asunaprevir 100 mg tablet by mouth twice daily for 7 days Receives: Drug: Asunaprevir |
| Arm D: Subjects with moderate renal impairment | Experimental | Asunaprevir 100 mg tablet by mouth twice daily for 7 days Receives: Drug: Asunaprevir |
| Arm E: Subjects with severe renal impairment | Experimental | Asunaprevir 100 mg tablet by mouth twice daily for 7 days Receives: Drug: Asunaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(TAU) of Asunaprevir assessed using plasma concentrations on Day 7
Area under the concentration-time curve in one dosing interval [AUC(TAU)] will be calculated from the blood drug concentration versus time curve
Measured: 11 time points on Day 7
Secondary outcomes (16)
Plasma protein binding (PB) of Asunaprevir will be determined from the 1 hour and 3 hour time points post-dose
Measured: 1 and 3 hours of Day 7
Maximum observed plasma concentration (Cmax) of Asunaprevir
Pharmacokinetic (PK) parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Unbound Maximum observed plasma concentrations (Cmaxu) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Time of maximum observed plasma concentration (Tmax) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Minimum observed plasma concentration at one dose interval (C12) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Minimum observed plasma concentration at Pre-AM dose (Ctrough) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 3 time points up to Day 7 (blood) and 2 time points on Days 1 and 7 (urine)
Unbound area under the concentration-time curve in one dosing interval [AUC(TAU)u] of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Area under the concentration-time curve till time of last sampling [AUC(0-T)] of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 11 (blood) and 2 (urine) time points on Day 7
Terminal elimination half life (T-Half) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Percent urinary recovery (%UR) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 3 time points up to Day 7 (urine)
Apparent total body clearance (CLT/F) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Unbound apparent clearance (CLU/F) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Renal clearance (CLR) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Apparent volume of distribution (Vd/F) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Accumulation index (AI): Ratio of AUC(TAU) on Day 7 to AUC(TAU) on Day 1
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Measured: 22 (blood) and 3 (urine) time points on Days 1 and 7
Safety and tolerability endpoints include all AEs and serious AEs, clinical laboratory tests, ECGs, vital signs and physical examination results
All recorded adverse events (AEs) will be listed and tabulated by system organ class, preferred term and renal function group. Vital signs and clinical laboratory test results will be listed and summarized by renal function group and time. Any significant physical examination findings and clinical laboratory results will be listed. Electrocardiogram (ECG) readings will be evaluated by the investigator and abnormalities, if present, will be listed
Measured: Up to Day 15 and until 30 days post discontinuation of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startNov 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT01886599
- Sponsor's protocol ID
- AI447-033
- Status last verified
- Nov 2013
- First submitted
- 24 Jun 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Parallel Group, Multiple-Dose Study to Evaluate the Pharmacokinetics and Safety of Asunaprevir in Subjects With Renal Function Impairment
- ClinicalTrials.gov ID
- NCT01886599
- Acronym / sponsor ID
- AI447-033
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 26 Jun 2013 (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.
The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function
Detailed description
Primary Purpose:
Other: The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A: Subjects with normal renal function | Experimental | Drug: AsunaprevirAsunaprevir 100 mg tablet by mouth twice daily for 7 days |
| Arm B: Subjects with end stage renal disease | Experimental | Drug: AsunaprevirAsunaprevir 100 mg tablet by mouth twice daily for 7 days |
| Arm C: Subjects with mild renal impairment | Experimental | Drug: AsunaprevirAsunaprevir 100 mg tablet by mouth twice daily for 7 days |
| Arm D: Subjects with moderate renal impairment | Experimental | Drug: AsunaprevirAsunaprevir 100 mg tablet by mouth twice daily for 7 days |
| Arm E: Subjects with severe renal impairment | Experimental | Drug: AsunaprevirAsunaprevir 100 mg tablet by mouth twice daily for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Group A: Subjects with normal renal function
- Group B: Patients with end stage renal disease
- Group C: Patients with mild renal impairment
- Group D: Patients with moderate renal impairment
- Group E: Patients with severe renal impairment
Key exclusion criteria (4 listed)
- History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease
- Hepatitis B or C
- Human Immunodeficiency Virus (HIV)
- Recent gastrointestinal disease
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 |
|---|---|---|
| AsunaprevirAlso: BMS-650032 | Drug | Arm A: Subjects with normal renal function, Arm B: Subjects with end stage renal disease, Arm C: Subjects with mild renal impairment, Arm D: Subjects with moderate renal impairment, Arm E: Subjects with severe renal impairment |
Primary outcome
AUC(TAU) of Asunaprevir assessed using plasma concentrations on Day 7
Time frame: 11 time points on Day 7
Area under the concentration-time curve in one dosing interval [AUC(TAU)] will be calculated from the blood drug concentration versus time curve
16 secondary outcomes
Plasma protein binding (PB) of Asunaprevir will be determined from the 1 hour and 3 hour time points post-dose
Time frame: 1 and 3 hours of Day 7
Maximum observed plasma concentration (Cmax) of Asunaprevir
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Unbound Maximum observed plasma concentrations (Cmaxu) of Asunaprevir
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Time of maximum observed plasma concentration (Tmax) of Asunaprevir
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Minimum observed plasma concentration at one dose interval (C12) of Asunaprevir
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Minimum observed plasma concentration at Pre-AM dose (Ctrough) of Asunaprevir
Time frame: 3 time points up to Day 7 (blood) and 2 time points on Days 1 and 7 (urine)
Unbound area under the concentration-time curve in one dosing interval [AUC(TAU)u] of Asunaprevir
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Area under the concentration-time curve till time of last sampling [AUC(0-T)] of Asunaprevir
Time frame: 11 (blood) and 2 (urine) time points on Day 7
Terminal elimination half life (T-Half) of Asunaprevir
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Percent urinary recovery (%UR) of Asunaprevir
Time frame: 3 time points up to Day 7 (urine)
Apparent total body clearance (CLT/F) of Asunaprevir
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Unbound apparent clearance (CLU/F) of Asunaprevir
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Renal clearance (CLR) of Asunaprevir
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Apparent volume of distribution (Vd/F) of Asunaprevir
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Accumulation index (AI): Ratio of AUC(TAU) on Day 7 to AUC(TAU) on Day 1
Time frame: 22 (blood) and 3 (urine) time points on Days 1 and 7
Safety and tolerability endpoints include all AEs and serious AEs, clinical laboratory tests, ECGs, vital signs and physical examination results
Time frame: Up to Day 15 and until 30 days post discontinuation of dosing
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 11 Nov 2013.
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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 Asunaprevir in people with Hepatitis C, 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 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 11 Nov 2013. 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 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(TAU) of Asunaprevir assessed using plasma concentrations on Day 7 (time frame: 11 time points on Day 7). 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 11 Nov 2013.