Hepatitis CPhase 1NCT02104843

Drug Interaction Between Daclatasvir/Asunaprevir/BMS-791325 and Rosuvastatin

A Phase 1 study testing Daclatasvir, Asunaprevir and BMS-791325 FDC, BMS-791325 and Rosuvastatin in people with Hepatitis C, run by Bristol-Myers Squibb.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 combination therapy on the exposure of Rosuvastatin. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis C
What is being tested?: Daclatasvir, Asunaprevir and BMS-791325 FDC, BMS-791325 and Rosuvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: No sites listed yet
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy subjects with no clinically significant deviations from normal in medical history, physical exam findings, 12 lead ECG measurements and clinical laboratory tests
Females must be of non-childbearing potential

Who cannot join

Women of childbearing potential
Any significant acute or chronic medical condition
Inability to tolerate oral medications
Inability to be venipunctured and/or tolerate venous access
Abnormal liver function tests
Current or recent (within 3 months of dosing) gastrointestinal disease

About this study

Official title: Effect of Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Therapy on the Pharmacokinetics of Rosuvastatin

The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 combination therapy on the exposure of Rosuvastatin.

Read the detailed description

IND Number: 79,599/101,943

Primary Purpose: Other - Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Conditions: Hepatitis C
Being tested: Daclatasvir, Asunaprevir and BMS-791325 FDC, BMS-791325, Rosuvastatin
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Daclatasvir, Asunaprevir and BMS-791325 FDCDrug
BMS-791325Drug
RosuvastatinDrug
Also called Crestor®

Study groups in NCT02104843
Study group	Role	What they receive
Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin	Experimental	Treatment A: Rosuvastatin tablet orally on specified days Treatment B: Daclatasvir, Asunaprevir and BMS-791325 Fixed dose combination (FDC) + BMS-791325 tablet orally on specified days Treatment C: Daclatasvir, Asunaprevir and BMS-791325 FDC + BMS-791325 + Rosuvastatin tablet orally on specified days Receives: Drug: Daclatasvir, Asunaprevir and BMS-791325 FDC; Drug: BMS-791325; Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum observed concentration (Cmax) of Rosuvastatin
Measured: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of Rosuvastatin
Measured: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin
Measured: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)

Secondary outcomes (10)

Time of maximum observed concentration (Tmax) of Rosuvastatin
Measured: Days 1 and 15 (predose through 96 hours)
Half life (T-HALF) of Rosuvastatin
Measured: Days 1 and 15 (predose through 96 hours)
Apparent total body clearance (CLT/F) of Rosuvastatin
Measured: Days 1 and 15 (predose through 96 hours)
Maximum observed concentration (Cmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
Measured: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
Trough observed plasma concentration (predose) (Ctrough) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
Measured: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
Measured: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
Time of maximum observed concentration (Tmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
Measured: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
Observed plasma concentration at 12 hours after dosing in a pharmacokinetic (PK) profile (C12) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
Measured: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
Safety measured by incidence of Adverse events (AEs), Serious adverse events (SAEs) and AEs leading to discontinuation
Measured: Days 1 through 19
Safety measured by results of vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests
Measured: Days 1 through 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014May 2014

First posted4 Apr 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02104843
Sponsor's protocol ID: AI443-115
Status last verified: Jul 2014
First submitted: 2 Apr 2014
Last updated: 18 Jul 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Therapy on the Pharmacokinetics of Rosuvastatin
ClinicalTrials.gov ID: NCT02104843
Acronym / sponsor ID: AI443-115
Conditions: Hepatitis C
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 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: 4 Apr 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 primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 combination therapy on the exposure of Rosuvastatin.

Detailed description

IND Number: 79,599/101,943

Primary Purpose: Other - Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin	Experimental	Drug: Daclatasvir, Asunaprevir and BMS-791325 FDC, Drug: BMS-791325, Drug: RosuvastatinTreatment A: Rosuvastatin tablet orally on specified days Treatment B: Daclatasvir, Asunaprevir and BMS-791325 Fixed dose combination (FDC) + BMS-791325 tablet orally on specified days Treatment C: Daclatasvir, Asunaprevir and BMS-791325 FDC + BMS-791325 + Rosuvastatin tablet orally on specified days

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy subjects with no clinically significant deviations from normal in medical history, physical exam findings, 12 lead ECG measurements and clinical laboratory tests
Females must be of non-childbearing potential

Key exclusion criteria (6 listed)

Women of childbearing potential
Any significant acute or chronic medical condition
Inability to tolerate oral medications
Inability to be venipunctured and/or tolerate venous access
Abnormal liver function tests

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
Daclatasvir, Asunaprevir and BMS-791325 FDC	Drug	Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin
BMS-791325	Drug	Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin
RosuvastatinAlso: Crestor®	Drug	Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin

Primary outcome

Maximum observed concentration (Cmax) of Rosuvastatin
Time frame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of Rosuvastatin
Time frame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin
Time frame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)

10 secondary outcomes

Time of maximum observed concentration (Tmax) of Rosuvastatin
Time frame: Days 1 and 15 (predose through 96 hours)
Half life (T-HALF) of Rosuvastatin
Time frame: Days 1 and 15 (predose through 96 hours)
Apparent total body clearance (CLT/F) of Rosuvastatin
Time frame: Days 1 and 15 (predose through 96 hours)
Maximum observed concentration (Cmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
Time frame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
Trough observed plasma concentration (predose) (Ctrough) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
Time frame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
Time frame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
Time of maximum observed concentration (Tmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
Time frame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
Observed plasma concentration at 12 hours after dosing in a pharmacokinetic (PK) profile (C12) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
Time frame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
Safety measured by incidence of Adverse events (AEs), Serious adverse events (SAEs) and AEs leading to discontinuation
Time frame: Days 1 through 19
Safety measured by results of vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests
Time frame: Days 1 through 19

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 18 Jul 2014.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
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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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Daclatasvir, Asunaprevir and BMS-791325 FDC, BMS-791325 and Rosuvastatin in people with Hepatitis C, 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 2 inclusion and 6 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 18 Jul 2014. 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 concentration (Cmax) of Rosuvastatin (time frame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02104843.

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 18 Jul 2014.