Hepatitis CPhase 1NCT02103569

Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325

A Phase 1 study testing FDC of Daclatasvir, Asunaprevir and BMS-791325, FDC of Norethindrone and Ethinyl Estradiol and BMS-791325 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 purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive agent. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Hepatitis C
What is being tested?: FDC of Daclatasvir, Asunaprevir and BMS-791325, FDC of Norethindrone and Ethinyl Estradiol and BMS-791325
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: Apr 2014to Jul 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 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy females within age of 18-40 years
Must be a Women of Childbearing potential
Must be on a stable regimen of oral contraceptive therapy for at least 3 consecutive months prior to study start

Who cannot join

Subjects must not have any significant acute or chronic medical illnesses or conditions precluding safe use of oral contraceptives
Prior exposure to DCV, ASV or BMS-791325 within 30 days of dosing on study day 1
Smoking within 6 months of study start

About this study

Official title: Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects

The purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive agent.

Read the detailed description

IND Number: 79,599 and 101,943

Other: Phase 1 Clinical Pharmacology drug interaction study in healthy female subjects

Conditions: Hepatitis C
Being tested: FDC of Daclatasvir, Asunaprevir and BMS-791325, FDC of Norethindrone and Ethinyl Estradiol, 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.

FDC of Daclatasvir, Asunaprevir and BMS-791325Drug
FDC of Norethindrone and Ethinyl EstradiolDrug
Also called Loestrin®
BMS-791325Drug

Study groups in NCT02103569
Study group	Role	What they receive
Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325	Experimental	Cycle 1- Low dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days Cycle 2- High dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days and High dose FDC of Norethindrone and Ethinyl Estradiol + FDC of Daclatasvir, Asunaprevir and BMS-791325 + BMS-791325 tablets orally on specified days Receives: Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325; Drug: FDC of Norethindrone and Ethinyl Estradiol; Drug: BMS-791325

What is being measured

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

Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone
Measured: Day 21 to Day 49
Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone
Measured: Day 21 to Day 49

Secondary outcomes (7)

Dose-normalized area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone
Measured: Day 1 to Day 50
Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone
Measured: Day 1 to Day 50
Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone
Measured: Day 1 to Day 50
Safety measured by occurrence of Adverse events (AEs), serious AEs and AEs leading to discontinuation
Measured: Day 1 to Day 50
Safety measured by abnormalities in vital sign measurements
Measured: Day 1 to Day 50
Safety measured by findings on Electrocardiogram (ECG) measurements and physical examinations
Measured: Day 1 to Day 50
Safety measured by marked abnormalities in clinical laboratory test results
Measured: Day 1 to Day 50

Timeline

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

Apr 2014Jul 2014

First posted4 Apr 2014 (estimated)
Study startApr 2014
Primary completionJul 2014
Study completionJul 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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02103569
Sponsor's protocol ID: AI443-016
Status last verified: Aug 2014
First submitted: 1 Apr 2014
Last updated: 15 Aug 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

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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2014. 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 a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
ClinicalTrials.gov ID: NCT02103569
Acronym / sponsor ID: AI443-016
Conditions: Hepatitis C
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Jul 2014 (actual)
Study completion: Jul 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 purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive agent.

Detailed description

IND Number: 79,599 and 101,943

Other: Phase 1 Clinical Pharmacology drug interaction study in healthy female subjects

Study design

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

Arm	Type	Receives
Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325	Experimental	Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325, Drug: FDC of Norethindrone and Ethinyl Estradiol, Drug: BMS-791325Cycle 1- Low dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days Cycle 2- High dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days and High dose FDC of Norethindrone and Ethinyl Estradiol + FDC of Daclatasvir, Asunaprevir and BMS-791325 + BMS-791325 tablets orally on specified days

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy females within age of 18-40 years
Must be a Women of Childbearing potential
Must be on a stable regimen of oral contraceptive therapy for at least 3 consecutive months prior to study start

Key exclusion criteria (3 listed)

Subjects must not have any significant acute or chronic medical illnesses or conditions precluding safe use of oral contraceptives
Prior exposure to DCV, ASV or BMS-791325 within 30 days of dosing on study day 1
Smoking within 6 months of study start

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
FDC of Daclatasvir, Asunaprevir and BMS-791325	Drug	Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325
FDC of Norethindrone and Ethinyl EstradiolAlso: Loestrin®	Drug	Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325
BMS-791325	Drug	Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325

Primary outcome

Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone
Time frame: Day 21 to Day 49
Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone
Time frame: Day 21 to Day 49

7 secondary outcomes

Dose-normalized area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone
Time frame: Day 1 to Day 50
Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone
Time frame: Day 1 to Day 50
Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone
Time frame: Day 1 to Day 50
Safety measured by occurrence of Adverse events (AEs), serious AEs and AEs leading to discontinuation
Time frame: Day 1 to Day 50
Safety measured by abnormalities in vital sign measurements
Time frame: Day 1 to Day 50
Safety measured by findings on Electrocardiogram (ECG) measurements and physical examinations
Time frame: Day 1 to Day 50
Safety measured by marked abnormalities in clinical laboratory test results
Time frame: Day 1 to Day 50

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 15 Aug 2014.

Related trials for Hepatitis C

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Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
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Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
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

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 FDC of Daclatasvir, Asunaprevir and BMS-791325, FDC of Norethindrone and Ethinyl Estradiol and BMS-791325 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 3 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 15 Aug 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?

Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone (time frame: Day 21 to Day 49). 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?

On the ClinicalTrials.gov record for NCT02103569.

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 15 Aug 2014.