Hepatitis C InfectionPhase 1NCT02323594
A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir
A Phase 1 study testing Daclatasvir and Asunaprevir in people with Hepatitis C Infection, run by Bristol-Myers Squibb.
Trial summary
Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable tablets. Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet 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 Infection
- What is being tested?
- Daclatasvir and Asunaprevir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Feb 2015
- 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
- Signed Written Informed Consent must be obtained from the subjects in accordance with requirements of the study center's Institutional review Board (IRB)/ Institutional Ethics Committee (IEC)
- Target Population: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- Age and Reproductive Status : Males and females, ages 18 to 49 years, inclusive. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 24 hours prior to the start of study drug and must be using an acceptable method of contraception for 4 weeks prior to study drug administration. Women must not be breastfeeding.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for duration of treatment with study drug females must still undergo pregnancy testing as described in this section.
Who cannot join
- Medical History and Concurrent Diseases : Any significant acute or chronic medical illness. Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug. Any major surgery within 4 weeks of study drug administration. Any gastrointestinal surgery that could impact upon the absorption of study drug (appendectomies with no complications are allowed at the investigator's discretion). Inability to tolerate oral medication, smokers or recent durg or alcohol abuse and Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
- Physical and Laboratory Test Findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population, positive urine screen for drugs, positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibodies.
- Allergies and Adverse Drug Reaction : History of allergy to DCV, ASV, Hepatitis C virus (HCV) NS3 protease inhibitors, HCV NS5A replication cofactors, or related compounds.
About this study
Official title: A Bioequivalence Study of the 90-mg Daclatasvir Tablet Relative to the 3 × 30-mg Daclatasvir Phase 3 Tablets, and Relative Bioavailability Studies of Chewable Pediatric Tablets of Daclatasvir and Asunaprevir in Healthy Adult Subjects
Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable tablets.
Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet
- Conditions
- Hepatitis C Infection
- Being tested
- Daclatasvir, 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.
DaclatasvirDrug
Treatment A= single oral dose of Daclatasvir (DCV) tablet and Treatment B= single oral dose of DCV pediatric chewable tablet
DaclatasvirDrug
Treatment C= single oral dose of Daclatasvir (DCV) pediatric chewable tablet and Treatment D= single oral dose of DCV pediatric chewable tablet
AsunaprevirDrug
Treatment E= single oral dose of Asunaprevir (ASV) tablet and Treatment F= single oral dose of ASV pediatric chewable tablet and Treatment G= single oral dose of of ASV pediatric chewable tablet
DaclatasvirDrug
Treatment H= single oral dose of Daclatasvir (DCV) tablet and Treatment I= single oral dose of DCV tablets
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Daclatasvir | Experimental | Single oral dose of Daclatasvir (DCV) tablet and single oral dose of DCV pediatric chewable tablet Receives: Drug: Daclatasvir |
| Group 2: Daclatasvir | Experimental | Single oral dose of Daclatasvir (DCV) pediatric chewable tablet and single oral dose of DCV pediatric chewable tablet Receives: Drug: Daclatasvir |
| Group 3: Asunaprevir | Experimental | Single oral dose of Asunaprevir (ASV) tablet, single oral dose of ASV pediatric chewable tablet and single oral dose of ASV pediatric chewable tablets Receives: Drug: Asunaprevir |
| Group 4: Daclatasvir | Experimental | Single oral dose of Daclatasvir (DCV) tablet and single oral dose of DCV tablets Receives: Drug: Daclatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration [Cmax]
Measured: Before dosing through 96 hours
Area under the concentration-time curve [AUC] from time zero extrapolated to infinite time [AUC(INF)]
Measured: Before dosing through 96 hours
AUC from time zero to the time of last quantifiable concentration [AUC(0-T)]
Measured: Before dosing through 96 hours
Time of maximum observed plasma concentration [Tmax]
Measured: Before dosing through 96 hours
Terminal plasma half life [T-HALF])
Measured: Before dosing through 96 hours
Secondary outcomes (6)
Adverse Event reports
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
Measured: 30 days after last dose
Vital sign measurements
Measured: 30 days after last dose
ECGs
Measured: 30 days after last dose
Physical examinations
Measured: 30 days after last dose
Clinical laboratory tests
Measured: 30 days after last dose
The incidence of reported AEs will be tabulated and reviewed for potential significance and clinical importance.
Measured: 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C InfectionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca N Wood-Horrall, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323594
- Sponsor's protocol ID
- AI447-111
- Status last verified
- Dec 2014
- First submitted
- 9 Dec 2014
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study of the 90-mg Daclatasvir Tablet Relative to the 3 × 30-mg Daclatasvir Phase 3 Tablets, and Relative Bioavailability Studies of Chewable Pediatric Tablets of Daclatasvir and Asunaprevir in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02323594
- Acronym / sponsor ID
- AI447-111
- Conditions
- Hepatitis C Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 Dec 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.
Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable tablets.
Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Daclatasvir | Experimental | Drug: DaclatasvirSingle oral dose of Daclatasvir (DCV) tablet and single oral dose of DCV pediatric chewable tablet |
| Group 2: Daclatasvir | Experimental | Drug: DaclatasvirSingle oral dose of Daclatasvir (DCV) pediatric chewable tablet and single oral dose of DCV pediatric chewable tablet |
| Group 3: Asunaprevir | Experimental | Drug: AsunaprevirSingle oral dose of Asunaprevir (ASV) tablet, single oral dose of ASV pediatric chewable tablet and single oral dose of ASV pediatric chewable tablets |
| Group 4: Daclatasvir | Experimental | Drug: DaclatasvirSingle oral dose of Daclatasvir (DCV) tablet and single oral dose of DCV tablets |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed Written Informed Consent must be obtained from the subjects in accordance with requirements of the study center's Institutional review Board (IRB)/ Institutional Ethics Committee (IEC)
- Target Population: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- Age and Reproductive Status : Males and females, ages 18 to 49 years, inclusive. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 24 hours prior to the start of study drug and must be using an acceptable method of contraception for 4 weeks prior to study drug administration. Women must not be breastfeeding.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for duration of treatment with study drug females must still undergo pregnancy testing as described in this section.
Key exclusion criteria (3 listed)
- Medical History and Concurrent Diseases : Any significant acute or chronic medical illness. Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug. Any major surgery within 4 weeks of study drug administration. Any gastrointestinal surgery that could impact upon the absorption of study drug (appendectomies with no complications are allowed at the investigator's discretion). Inability to tolerate oral medication, smokers or recent durg or alcohol abuse and Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
- Physical and Laboratory Test Findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population, positive urine screen for drugs, positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibodies.
- Allergies and Adverse Drug Reaction : History of allergy to DCV, ASV, Hepatitis C virus (HCV) NS3 protease inhibitors, HCV NS5A replication cofactors, or related compounds.
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 |
|---|---|---|
| DaclatasvirTreatment A= single oral dose of Daclatasvir (DCV) tablet and Treatment B= single oral dose of DCV pediatric chewable tablet | Drug | Group 1: Daclatasvir |
| DaclatasvirTreatment C= single oral dose of Daclatasvir (DCV) pediatric chewable tablet and Treatment D= single oral dose of DCV pediatric chewable tablet | Drug | Group 2: Daclatasvir |
| AsunaprevirTreatment E= single oral dose of Asunaprevir (ASV) tablet and Treatment F= single oral dose of ASV pediatric chewable tablet and Treatment G= single oral dose of of ASV pediatric chewable tablet | Drug | Group 3: Asunaprevir |
| DaclatasvirTreatment H= single oral dose of Daclatasvir (DCV) tablet and Treatment I= single oral dose of DCV tablets | Drug | Group 4: Daclatasvir |
Primary outcome
Maximum observed plasma concentration [Cmax]
Time frame: Before dosing through 96 hours
Area under the concentration-time curve [AUC] from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Before dosing through 96 hours
AUC from time zero to the time of last quantifiable concentration [AUC(0-T)]
Time frame: Before dosing through 96 hours
Time of maximum observed plasma concentration [Tmax]
Time frame: Before dosing through 96 hours
Terminal plasma half life [T-HALF])
Time frame: Before dosing through 96 hours
6 secondary outcomes
Adverse Event reports
Time frame: 30 days after last dose
Vital sign measurements
Time frame: 30 days after last dose
ECGs
Time frame: 30 days after last dose
Physical examinations
Time frame: 30 days after last dose
Clinical laboratory tests
Time frame: 30 days after last dose
The incidence of reported AEs will be tabulated and reviewed for potential significance and clinical importance.
Time frame: 30 days after last dose
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 24 Feb 2015.
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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.
Rebecca N Wood-Horrall, MD principal investigator
PPD Development, LP
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Daclatasvir and Asunaprevir in people with Hepatitis C Infection, run by Bristol-Myers Squibb.
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 4 inclusion and 3 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 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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] (time frame: Before dosing through 96 hours). The study lists 5 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 24 Feb 2015.