Hepatitis C InfectionPhase 1NCT02175602
Study of Drug Combination on Pharmacokinetics in Healthy Volunteers
A Phase 1 study testing Escitalopram, Sertraline and DCV 3DAA FDC in people with Hepatitis C Infection, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325 on the pharmacokinetics of selective serotonin reuptake inhibitors. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Infection
- What is being tested?
- Escitalopram, Sertraline and DCV 3DAA FDC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Aug 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed Informed Consent Form
- Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.
- Target Population
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, psychiatric history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results.
- Age and Reproductive Status
- Males and females, ages 25 to 55 years, inclusive.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
- Women must not be breastfeeding.
Who cannot join
- 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 (appendectomies with no complications are allowed at the investigator's discretion).
- Any major surgery within 4 weeks of study drug administration.
- Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration).
- Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
About this study
Official title: Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of Selective Serotonin Reuptake Inhibitors in Healthy Subjects
The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325 on the pharmacokinetics of selective serotonin reuptake inhibitors.
- Conditions
- Hepatitis C Infection
- Being tested
- Escitalopram, Sertraline, DCV 3DAA FDC, BMS-791325
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
10 milligrams administered each morning
SertralineDrug
Also called Zoloft
50 milligrams administered each morning
DCV 3DAA FDCDrug
Fixed dose combination (daclatasvir [DCV] 30 milligrams, asunaprevir [ASV] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily
BMS-791325Drug
75 milligrams single-agent film coated oral tablet administered twice daily
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2 | Experimental | Sertraline (50 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Sertraline (50 milligrams each morning) days 23-29 Receives: Drug: Sertraline; Drug: DCV 3DAA FDC; Drug: BMS-791325 |
| Cohort 1 | Experimental | Escitalopram (10 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Escitalopram (10 milligrams each morning) days 23-29 Receives: Drug: Escitalopram; Drug: DCV 3DAA FDC; Drug: BMS-791325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial blood samples for plasma SSRI (selective serotonin reuptake inhibitor) of escitalopram or sertraline
Measured: Before dosing (0 hour) through 24 hours after SSRI administration on day 7 and day 29
Serial blood samples for determination of plasma concentrations of DCV (daclatasvir), ASV (asunaprevir), BMS-791325, and the metabolite BMS-794712
Measured: Before dosing (0 hour) through 12 hours after SSRI administration on day 22 and day 29
Secondary outcomes (1)
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
Measured: Two to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ikenna Ogbaa, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175602
- Sponsor's protocol ID
- AI443-116
- Status last verified
- Feb 2015
- First submitted
- 24 Jun 2014
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of Selective Serotonin Reuptake Inhibitors in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02175602
- Acronym / sponsor ID
- AI443-116
- Conditions
- Hepatitis C Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- First posted
- 26 Jun 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 Daclatasvir, Asunaprevir, and BMS-791325 on the pharmacokinetics of selective serotonin reuptake inhibitors.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 2 | Experimental | Drug: Sertraline, Drug: DCV 3DAA FDC, Drug: BMS-791325Sertraline (50 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Sertraline (50 milligrams each morning) days 23-29 |
| Cohort 1 | Experimental | Drug: Escitalopram, Drug: DCV 3DAA FDC, Drug: BMS-791325Escitalopram (10 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Escitalopram (10 milligrams each morning) days 23-29 |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed Informed Consent Form
- Target Population
- Age and Reproductive Status
Key exclusion criteria (5 listed)
- 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 (appendectomies with no complications are allowed at the investigator's discretion).
- Any major surgery within 4 weeks of study drug administration.
- Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration).
- Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
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 |
|---|---|---|
| EscitalopramAlso: Lexapro10 milligrams administered each morning | Drug | Cohort 1 |
| SertralineAlso: Zoloft50 milligrams administered each morning | Drug | Cohort 2 |
| DCV 3DAA FDCFixed dose combination (daclatasvir [DCV] 30 milligrams, asunaprevir [ASV] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily | Drug | Cohort 1, Cohort 2 |
| BMS-79132575 milligrams single-agent film coated oral tablet administered twice daily | Drug | Cohort 1, Cohort 2 |
Primary outcome
Serial blood samples for plasma SSRI (selective serotonin reuptake inhibitor) of escitalopram or sertraline
Time frame: Before dosing (0 hour) through 24 hours after SSRI administration on day 7 and day 29
Serial blood samples for determination of plasma concentrations of DCV (daclatasvir), ASV (asunaprevir), BMS-791325, and the metabolite BMS-794712
Time frame: Before dosing (0 hour) through 12 hours after SSRI administration on day 22 and day 29
1 secondary outcome
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
Time frame: Two to three months
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 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.
Ikenna Ogbaa, MD principal investigator
PPD Development, LP
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Escitalopram, Sertraline and DCV 3DAA FDC 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 8 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: finished, as of the sponsor's last update on 10 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?
Serial blood samples for plasma SSRI (selective serotonin reuptake inhibitor) of escitalopram or sertraline (time frame: Before dosing (0 hour) through 24 hours after SSRI administration on day 7 and day 29). 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 Feb 2015.