Chronic Hepatitis CPhase 1NCT00983957

Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects

A Phase 1 study testing BMS-790052 and Ortho Tri-Cyclen® in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 3 sites in 2 countries.

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 BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Chronic Hepatitis C
What is being tested?: BMS-790052 and Ortho Tri-Cyclen®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 3 sitesin 2 countries
Study dates: Oct 2009to Feb 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy female subjects, 18-45 years, BMI 18-32 kg/m².
Must be using an adequate method of contraception to avoid pregnancy throughout the study.

Who cannot join

Abnormal Pap smear within 1 yr of dosing, and abnormal menstrual cycle during the 3 months prior to enrollment.
Any significant or chronic uncontrolled medical illness.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United States2 sites

Covance Clinical Research Unit, Inc.
Austin, Texas, 78752
MDS Pharma Services (US), Inc
Tempe, Arizona, 85283

Other trials in United States

Canada1 site

Local Institution
Saint-Laurent, Quebec, H4R2N6

Other trials in Canada

About this study

Official title: The Effect of the Co-administration of BMS-790052 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri-Cyclen®) in Healthy Female Subjects

The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects.

Conditions: Chronic Hepatitis C
Being tested: BMS-790052, Ortho Tri-Cyclen®
Medical subject headings: Hepatitis C, Chronic

What participants receive

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

BMS-790052Drug
Tablets, Oral, 60 mg, once daily, 10 days
Ortho Tri-Cyclen®Drug
Tablets, Oral, once daily, 78 days

Study groups in NCT00983957
Study group	Role	What they receive
BMS-790052 plus Ortho Tri-Cyclen®	Experimental	Not described Receives: Drug: BMS-790052; Drug: Ortho Tri-Cyclen®

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol
Ethinyl Estradiol is an analyte of Ortho Tri-Cyclen. Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry (LC-MS/MS) by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Days 49 and 77
Area Under the Concentration-Time Curve (AUC) in 1 Dosing Interval of Ethinyl Estradiol
Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Time of Maximum Observed Plasma Concentration of Ethinyl Estradiol
Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Maximum Observed Plasma Concentration of Norelgestromin
Norelgestromin is a major active metabolite of norgestimate (NGM) which is found in Ortho Tri-Cyclen. Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Area Under the Concentration-Time Curve in 1 Dosing Interval of Norelgestromin
Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in nanograms multiplied by hours (h) per milliliter (ng*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Time of Maximum Observed Plasma Concentration of Norelgestromin
Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77

Secondary outcomes (7)

Maximum Observed Plasma Concentration of Norgestrel
Norgestrel is an NGM metabolite and was measured in plasma using liquid chromatography-mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Area Under the Concentration-Time Curve in 1 Dosing Interval of Norgestrel
Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Time of Maximum Observed Plasma Concentration of Norgestrel
Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Measured: For AEs from start of treatment (Day 1) up to Day 78 or discharge and for SAEs from Day 1 to 30 days after last dose of study drug
Number of Participants With Laboratory Test Abnormalities
Laboratory marked abnormalities were defined as Hematocrit (low) as <0.85*Pre-treatment (PreRx), Hemoglobin (low) as <0.85*PreRx, Aspartate Aminotransferase (AST) (high) as >1.25*PreRx if PreRx > upper limits of normal (ULN); >1.25*ULN if PreRx <=ULN; >1.25*ULN if PreRx = Missing, Blood in urine (high) as ≥2 PreRx if PreRx ≥1; ≥2 if PreRx <1; ≥2 if PreRx = Missing.
Measured: From start of treatment (Day 1) up to Day 78 or discharge
Number of Participants Demonstrating a Clinically Meaningful Effect in Vital Signs
Vital Signs were measured after the participant was seated quietly for at least 5 minutes and included systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature. Baseline = Last non-missing pretreatment value.
Measured: Baseline, Day 28, Day 29, Day 67, Day 68, Day 78, Day of discharge
Number of Participants Demonstrating a Clinically Meaningful Effect in ECG Parameters
The electrocardiogram (ECG) evaluations were performed within ± 15 minutes of the relative time points. ECGs were recorded after the participants were in supine position for at least 5 minutes. ECG parameters measured were: PR interval, QRS complex, QT interval and corrected QT (QTc).
Measured: Screening, Day 1, Day 67, Day 77

Timeline

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

Oct 2009Feb 2010

First posted24 Sep 2009 (estimated)
Study startOct 2009
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic 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: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00983957
Sponsor's protocol ID: AI444-020
Status last verified: Sep 2015
First submitted: 23 Sep 2009
Last updated: 16 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
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?

See locations

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RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
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Enrolling by invitationObservational study
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All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of the Co-administration of BMS-790052 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri-Cyclen®) in Healthy Female Subjects
ClinicalTrials.gov ID: NCT00983957
Acronym / sponsor ID: AI444-020
Conditions: Chronic Hepatitis C
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 24 Sep 2009 (estimated)
Results: Posted 16 Sep 2015

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 BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects.

Study design

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

Arm	Type	Receives
BMS-790052 plus Ortho Tri-Cyclen®	Experimental	Drug: BMS-790052, Drug: Ortho Tri-Cyclen®

Who may qualify

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

Key inclusion criteria (2 listed)

Healthy female subjects, 18-45 years, BMI 18-32 kg/m².
Must be using an adequate method of contraception to avoid pregnancy throughout the study.

Key exclusion criteria (2 listed)

Abnormal Pap smear within 1 yr of dosing, and abnormal menstrual cycle during the 3 months prior to enrollment.
Any significant or chronic uncontrolled medical illness.

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
BMS-790052Tablets, Oral, 60 mg, once daily, 10 days	Drug	BMS-790052 plus Ortho Tri-Cyclen®
Ortho Tri-Cyclen®Tablets, Oral, once daily, 78 days	Drug	BMS-790052 plus Ortho Tri-Cyclen®

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Days 49 and 77
Ethinyl Estradiol is an analyte of Ortho Tri-Cyclen. Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry (LC-MS/MS) by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Area Under the Concentration-Time Curve (AUC) in 1 Dosing Interval of Ethinyl Estradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Time of Maximum Observed Plasma Concentration of Ethinyl Estradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Maximum Observed Plasma Concentration of Norelgestromin
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Norelgestromin is a major active metabolite of norgestimate (NGM) which is found in Ortho Tri-Cyclen. Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Area Under the Concentration-Time Curve in 1 Dosing Interval of Norelgestromin
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in nanograms multiplied by hours (h) per milliliter (ng*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Time of Maximum Observed Plasma Concentration of Norelgestromin
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.

7 secondary outcomes

Maximum Observed Plasma Concentration of Norgestrel
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Area Under the Concentration-Time Curve in 1 Dosing Interval of Norgestrel
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Time of Maximum Observed Plasma Concentration of Norgestrel
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died
Time frame: For AEs from start of treatment (Day 1) up to Day 78 or discharge and for SAEs from Day 1 to 30 days after last dose of study drug
Number of Participants With Laboratory Test Abnormalities
Time frame: From start of treatment (Day 1) up to Day 78 or discharge
Number of Participants Demonstrating a Clinically Meaningful Effect in Vital Signs
Time frame: Baseline, Day 28, Day 29, Day 67, Day 68, Day 78, Day of discharge
Number of Participants Demonstrating a Clinically Meaningful Effect in ECG Parameters
Time frame: Screening, Day 1, Day 67, Day 77

Results and safety

Results posted to the registry on 16 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ortho Tri-Cyclen + Daclatasvir	20	18

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Days 49 and 77. Geometric mean (Geometric Coefficient of Variation). Unit: picogram per millilitre (pg/mL)

Measure	Ortho Tri-Cyclen n = 20	Ortho Tri-Cyclen + Daclatasvir n = 18
Value	118.53 (34)	134.70 (30)

Ortho Tri-Cyclen vs Ortho Tri-Cyclen + Daclatasvir: Adjusted geometric mean ratio: 1.105 (90% CI 1.023 to 1.195)

Population analysed: All participants who received the study drug.

Primary outcome: Area Under the Concentration-Time Curve (AUC) in 1 Dosing Interval of Ethinyl Estradiol

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77. Geometric mean (Geometric Coefficient of Variation). Unit: pg*h/mL

Measure	Ortho Tri-Cyclen n = 20	Ortho Tri-Cyclen + Daclatasvir n = 18
Value	959.37 (38)	994.40 (35)

Ortho Tri-Cyclen vs Ortho Tri-Cyclen + Daclatasvir: Adjusted geometric mean: 1.009 (90% CI 0.951 to 1.070)

Population analysed: All participants who received the study drug.

Primary outcome: Time of Maximum Observed Plasma Concentration of Ethinyl Estradiol

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77. Median (Full Range). Unit: hours

Measure	Ortho Tri-Cyclen n = 20	Ortho Tri-Cyclen + Daclatasvir n = 18
Value	1.5 (1.0 to 2.0)	1.5 (1.0 to 2.0)

Population analysed: All participants who received the study drug

Primary outcome: Maximum Observed Plasma Concentration of Norelgestromin

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per millilitre (ng/mL)

Measure	Ortho Tri-Cyclen n = 20	Ortho Tri-Cyclen + Daclatasvir n = 18
Value	1.99 (20)	2.10 (20)

Ortho Tri-Cyclen vs Ortho Tri-Cyclen + Daclatasvir: Adjusted geometric mean ratio: 1.059 (90% CI 0.988 to 1.135)

Population analysed: All participants who received the study drug.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of treatment (Day 1) up to Day 78 or discharge. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Treated Participants	0 of 20 (0%)	16 of 20 (80%)	Not reported
Ortho Tri-Cyclen Days 1-28	0 of 20 (0%)	8 of 20 (40%)	Not reported
Ortho Tri-Cyclen Days 29-46	0 of 20 (0%)	3 of 20 (15%)	Not reported
Ortho Tri-Cyclen Days 47-56	0 of 20 (0%)	7 of 20 (35%)	Not reported
Ortho Tri-Cyclen Days 57-67	0 of 18 (0%)	5 of 18 (27.8%)	Not reported
Ortho Tri-Cyclen + Daclatasvir Days 68-77	0 of 18 (0%)	12 of 18 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-790052 and Ortho Tri-Cyclen® in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 3 sites in 2 countries.

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 2 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 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 16 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Ethinyl Estradiol (time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Days 49 and 77). The study lists 6 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 NCT00983957.

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 16 Oct 2015.