Hepatitis CPhase 1NCT02095860
Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325
A Phase 1 study testing DCV 3DAA FDC in people with Hepatitis C, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- DCV 3DAA FDC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2014
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects ages 18 to 49 years, inclusive.
- Women of childbearing potential must be using an acceptable method of contraception for at least 4 weeks prior to study drug administration.
Who cannot join
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy
- History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease
- Use of tobacco-containing or nicotine-containing products
- Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat:
Show all 15Show fewer
- PR ≥210 msec
- QRS ≥120 msec
- QT ≥500 msec
- QTcF ≥450 msec
- Any of the following laboratory results outside of the ranges specified below prior to study drug administration, confirmed by repeat:
- Alanine aminotransferase (ALT) >Upper limit of normal (ULN)
- Aspartate aminotransferase (AST) >ULN
- Total bilirubin (TBILI) >ULN
- Creatinine >ULN
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthcare Discoveries, Llc D/B/A Icon Development Solutions
San Antonio, Texas, 78209
About this study
Official title: An Open-label, Randomized, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Daclatasvir, Asunaprevir, and BMS-791325 Following Administration of a Single Fixed Dose Combination of DCV 3DAA FDC in Healthy Subjects
The purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy subjects.
Read the detailed description
IND Number: 100,932/79,599/101,943
Primary Purpose:
Other: Phase 1 clinical pharmacology bioavailability study to assess food effect
- Conditions
- Hepatitis C
- Being tested
- DCV 3DAA FDC
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCV 3DAA FDCDrug
Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: DCV 3DAA FDC fasted state | Experimental | DCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state Receives: Drug: DCV 3DAA FDC |
| Treatment B: DCV 3DAA FDC with high-fat meal | Experimental | DCV 3DAA FDC tablet by mouth once on specified days with high-fat meal Receives: Drug: DCV 3DAA FDC |
| Treatment C: DCV 3DAA FDC with light meal | Experimental | DCV 3DAA FDC tablet by mouth once on specified days with light meal Receives: Drug: DCV 3DAA FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325
Measured: Day 1 to Day 13
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of DCV, ASV and BMS-791325
Measured: Day 1 to Day 13
Secondary outcomes (12)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for DCV, ASV and BMS-791325
Measured: Day 1 to Day 13
Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325
Measured: Day 1 to Day 13
Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325
Measured: Day 1 to Day 13
AUC(0-T) for BMS-794712
Measured: Day 1 to Day 13
AUC(INF) for BMS-794712
Measured: Day 1 to Day 13
Cmax for BMS-794712
Measured: Day 1 to Day 13
Tmax for BMS-794712
Measured: Day 1 to Day 13
T-HALF for BMS-794712
Measured: Day 1 to Day 13
Safety measured by incidence of adverse event (AEs), serious AEs (SAEs) and AEs leading to discontinuation
Measured: Day 1 to Day 13
Safety measured by abnormalities in vital sign measurements
Measured: Day 1 to Day 13
Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations
Measured: Day 1 to Day 13
Safety measured by marked abnormalities in clinical laboratory test results
Measured: Day 1 to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionMay 2014
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02095860
- Sponsor's protocol ID
- AI443-111
- Status last verified
- Oct 2014
- First submitted
- 21 Mar 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Daclatasvir, Asunaprevir, and BMS-791325 Following Administration of a Single Fixed Dose Combination of DCV 3DAA FDC in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02095860
- Acronym / sponsor ID
- AI443-111
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Mar 2014 (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 this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy subjects.
Detailed description
IND Number: 100,932/79,599/101,943
Primary Purpose:
Other: Phase 1 clinical pharmacology bioavailability study to assess food effect
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A: DCV 3DAA FDC fasted state | Experimental | Drug: DCV 3DAA FDCDCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state |
| Treatment B: DCV 3DAA FDC with high-fat meal | Experimental | Drug: DCV 3DAA FDCDCV 3DAA FDC tablet by mouth once on specified days with high-fat meal |
| Treatment C: DCV 3DAA FDC with light meal | Experimental | Drug: DCV 3DAA FDCDCV 3DAA FDC tablet by mouth once on specified days with light meal |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female subjects ages 18 to 49 years, inclusive.
- Women of childbearing potential must be using an acceptable method of contraception for at least 4 weeks prior to study drug administration.
Key exclusion criteria (15 listed)
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy
- History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease
- Use of tobacco-containing or nicotine-containing products
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 |
|---|---|---|
| DCV 3DAA FDCFixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 | Drug | Treatment A: DCV 3DAA FDC fasted state, Treatment B: DCV 3DAA FDC with high-fat meal, Treatment C: DCV 3DAA FDC with light meal |
Primary outcome
Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325
Time frame: Day 1 to Day 13
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of DCV, ASV and BMS-791325
Time frame: Day 1 to Day 13
12 secondary outcomes
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for DCV, ASV and BMS-791325
Time frame: Day 1 to Day 13
Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325
Time frame: Day 1 to Day 13
Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325
Time frame: Day 1 to Day 13
AUC(0-T) for BMS-794712
Time frame: Day 1 to Day 13
AUC(INF) for BMS-794712
Time frame: Day 1 to Day 13
Cmax for BMS-794712
Time frame: Day 1 to Day 13
Tmax for BMS-794712
Time frame: Day 1 to Day 13
T-HALF for BMS-794712
Time frame: Day 1 to Day 13
Safety measured by incidence of adverse event (AEs), serious AEs (SAEs) and AEs leading to discontinuation
Time frame: Day 1 to Day 13
Safety measured by abnormalities in vital sign measurements
Time frame: Day 1 to Day 13
Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations
Time frame: Day 1 to Day 13
Safety measured by marked abnormalities in clinical laboratory test results
Time frame: Day 1 to Day 13
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 10 Oct 2014.
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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
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 DCV 3DAA FDC in people with Hepatitis C, 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 15 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 10 Oct 2014. 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 plasma concentration (Cmax) of DCV, ASV and BMS-791325 (time frame: Day 1 to Day 13). The study lists 2 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 10 Oct 2014.