Hepatitis CPhase 1NCT01181804

Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED)

A Phase 1 study testing boceprevir in people with Hepatitis C, run by Merck Sharp & Dohme LLC.

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis C
What is being tested?: boceprevir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 177 participants
Where: No sites listed yet
Study dates: Jun 2010to Dec 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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedules.
Subjects must be willing to give written informed consent for pharmacogenetic
testing, and able to adhere to applicable visit schedules.
Subjects of either gender and of any race between the ages of 18 and 65
years, inclusive, having a Body Mass Index (BMI) between 18 and 32,
inclusive. BMI = weight (kg)/height (m)^2. (Individuals with values outside (or

Show all 44Show fewer

indicate lower or higher) of these ranges may be enrolled if clinically
acceptable to the investigator and sponsor.)
Subjects' clinical laboratory tests (complete blood count [CBC], blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator and within an allowed expanded range supplied by sponsor. However, subject's liver function test results (ie, aspartate aminotransferase [AST], alanine aminotransferase [ALT]) must not be elevated above normal limits at Screening and on Day -1. No rescreening of liver function tests will be allowed.
Subjects must be free of any clinically significant disease that would interfere with the study evaluations.
The Screening 12 lead electrocardiogram [ECG] conduction intervals must be within gender specific normal range (e.g, ECG QTcB,measure in males ≤430 msec and QTcB measure in females ≤450 msec, PR interval ≤200 msec).
Vital sign measurements (taken after ~3 minutes in a sitting position) must be
within the following ranges: (Individuals with values outside of these ranges
may be enrolled if clinically acceptable to the investigator and sponsor.)
oral body temperature, between 35.0°C and 37.5°C
systolic blood pressure, 90 to 140 mm Hg
diastolic blood pressure, 45 to 90 mm Hg
pulse rate, 40 to 100 bpm
Female subjects must be:
postmenopausal (defined as 12 months with no menses, age > 40
years and with a follicle-stimulating hormone [FSH] level of >40 u/mL, and serum E2 < 73 pmol/L), or
surgically sterilized at least 3 months prior to baseline (eg, documented
hysterectomy or tubal ligation), or
premenopausal and if unsterilized must have used a medically
accepted method of contraception for 3 months (or abstained from
sexual intercourse) prior to the screening period, and agree to use a
medically accepted method of contraception during the trial (including
the screening period prior to receiving trial medication) and for
2 months after stopping the trial medication. An acceptable method of
contraception includes one of the following:
stable oral, transdermal, injectable, or sustained-release vaginal
hormonal contraceptive regimen without breakthrough uterine
bleeding for 3 months prior to Screening; in addition, during
study use of condom and/or spermicide (when marketed in the
country).
intrauterine device (inserted at least 2 months prior to Screening
visit); in addition, during study use of condom and/or spermicide
(when marketed in the country).
condom (male or female) with spermicide (when marketed
within the country),
diaphragm or cervical cap with spermicide (when marketed
within the country) and condom (male),
Non-vasectomized men must agree to use a condom with spermicide or abstain from sexual intercourse, during the trial and for 1 month after stopping the medication.

Who cannot join

Female subjects who are pregnant, intend to become pregnant (within
3 months of ending the study), or are breastfeeding.
Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study.
Any surgical or medical condition which might significantly alter the
absorption, distribution, metabolism or excretion of any drug. The investigator
should be guided by evidence of any of the following, and be discussed with

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the sponsor prior to enrollment into the trial:
history or presence of inflammatory bowel disease, ulcers,
gastrointestinal or rectal bleeding;
history of major gastrointestinal tract surgery such as gastrectomy,
gastroenterostomy, or bowel resection;
history of pancreatic injury or pancreatitis;
history or presence of liver disease or liver injury;
history or presence of impaired renal function as indicated by clinically
significant elevation in creatinine, blood urea nitrogen [BUN]/urea, urinary albumin, or
clinically significant urinary cellular constituents ; or
history of urinary obstruction or difficulty in voiding.
Subject who has a history of any infectious disease within 4 weeks prior to
drug administration that in the opinion of the investigator, affects the subject's ability to participate in the trial.
Subjects who are positive for hepatitis B surface antigen, hepatitis C
antibodies or human immunodeficiency virus [HIV].
Subjects who have a positive screen for drugs with a high potential for abuse
(during the Screening period or clinical conduct of the trial).
Subjects with a history of psychiatric or personality disorders that in the
opinion of the investigator and sponsor, affects the subject's ability to
participate in the trial.
Subjects with a history of alcohol or drug abuse in the past 2 years.- Subjects who have donated blood in the past 60 days.
Subjects who have previously received boceprevir.
Subjects who are currently participating in another clinical study or have
participated in a clinical study (e.g., laboratory or clinical evaluation) within 30 days of baseline.
Subjects who are part of the study staff personnel or family members of the
study staff personnel.
Subjects who have demonstrated allergic reactions (eg, food, drug, atopic
reactions or asthmatic episodes) which, in the opinion of the investigator and
sponsor, interfere with their ability to participate in the trial.
Subjects who smoke more than 10 cigarettes or equivalent tobacco use per
day.
Subjects who have a history of malignancy.
Subjects who have received any prohibited treatment (prescription and non prescription medication except acetaminophen, potent inhibitors and inducers of cytochrome P3A [CYP3A4], or vitamins and herbals) more recently than the indicated washout period prior to Randomization which, in the opinion of the investigator and sponsor, interferes with their ability to participate in the trial.

About this study

Official title: A Definitive Bioequivalence Study of a New Boceprevir (SCH 503034) Tablet Formulation Compared to the Current Capsule Form in Healthy Male and Female Subjects.

This is a single-dose, randomized, cross-sectional comparison study examining the relative safety and resulting blood level profiles after administration of a new boceprevir tablet formulation versus its current capsule formulation for treatment of chronic hepatitis C. In Part 1 of the study participants will receive boceprevir tablets and capsules under fed conditions. In Part 2 of the study a new group of participants will receive boceprevir tablets and capsules under fasted conditions.

Conditions: Hepatitis C
Being tested: boceprevir
Keywords: boceprevir, hepatitis C, bioequivalence, SCH 503034
Medical subject headings: Hepatitis C

What participants receive

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

boceprevirDrug
Also called SCH 503034
Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.
boceprevirDrug
Also called SCH 503034
Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.
boceprevirDrug
Also called SCH 503034
Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.
boceprevirDrug
Also called SCH 503034
Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.

Study groups in NCT01181804
Study group	Role	What they receive
Boceprevir Tablets then Capsules (fed)	Experimental	Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition. Receives: Drug: boceprevir
Boceprevir Capsules then tablets (fed)	Experimental	Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition. Receives: Drug: boceprevir
Boceprevir Tablets then Capsules (fasted)	Experimental	Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast, and then 4 days later will take a single dose of boceprevir capsules, orally, following an overnight fast. Receives: Drug: boceprevir
Boceprevir Capsules then Tablets (fasted)	Experimental	Participants on this study arm will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast, and then 4 days later will take a single dose of boceprevir tablets, orally, following an overnight fast. Receives: Drug: boceprevir

What is being measured

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

Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State
AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.
Measured: Predose through 72 hours post-dose
Maximum Plasma Concentration (Cmax) of Boceprevir Tablets Versus Capsules in Fed State
Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.
Measured: Predose through 72 hours post-dose
AUCtf for Boceprevir Tablets Versus Capsules in Fasted State
AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.
Measured: Predose through 72 hours post-dose
Cmax of Boceprevir Tablets Versus Capsules in Fasted State
Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.
Measured: Predose through 72 hours post-dose
AUC From Hour 0 to Infinity (AUCinf) in Fed State
AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.
Measured: Predose through 72 hours post-dose
AUCinf in Fasted State
AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.
Measured: Predose through 72 hours post-dose
Half Life (t1/2) of Boceprevir in Fed State
T1/2 is the time required for a given drug concentration to decrease by 50%.
Measured: Predose through 72 hours post-dose
t1/2 Boceprevir in Fasted State
T1/2 is the time required for a given drug concentration to decrease by 50%.
Measured: Predose through 72 hours post-dose

Timeline

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

Jun 2010Dec 2010

First posted13 Aug 2010 (estimated)
Study startJun 2010
Primary completionDec 2010
Study completionDec 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 Hepatitis CStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 177 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01181804
Sponsor's protocol ID: P06992
Status last verified: Mar 2017
First submitted: 12 Aug 2010
Last updated: 7 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

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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Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Definitive Bioequivalence Study of a New Boceprevir (SCH 503034) Tablet Formulation Compared to the Current Capsule Form in Healthy Male and Female Subjects.
ClinicalTrials.gov ID: NCT01181804
Acronym / sponsor ID: P06992
Conditions: Hepatitis C
Keywords: boceprevir, hepatitis C, bioequivalence, SCH 503034
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 177 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 13 Aug 2010 (estimated)
Results: Posted 18 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Boceprevir Tablets then Capsules (fed)	Experimental	Drug: boceprevirParticipants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
Boceprevir Capsules then tablets (fed)	Experimental	Drug: boceprevirParticipants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
Boceprevir Tablets then Capsules (fasted)	Experimental	Drug: boceprevirParticipants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast, and then 4 days later will take a single dose of boceprevir capsules, orally, following an overnight fast.
Boceprevir Capsules then Tablets (fasted)	Experimental	Drug: boceprevirParticipants on this study arm will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast, and then 4 days later will take a single dose of boceprevir tablets, orally, following an overnight fast.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (44 listed)

Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedules.
Subjects must be willing to give written informed consent for pharmacogenetic
testing, and able to adhere to applicable visit schedules.
Subjects of either gender and of any race between the ages of 18 and 65
years, inclusive, having a Body Mass Index (BMI) between 18 and 32,

Key exclusion criteria (39 listed)

Female subjects who are pregnant, intend to become pregnant (within
3 months of ending the study), or are breastfeeding.
Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study.
Any surgical or medical condition which might significantly alter the
absorption, distribution, metabolism or excretion of any drug. 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
boceprevirAlso: SCH 503034Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.	Drug	Boceprevir Tablets then Capsules (fed)
boceprevirAlso: SCH 503034Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.	Drug	Boceprevir Capsules then tablets (fed)
boceprevirAlso: SCH 503034Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.	Drug	Boceprevir Tablets then Capsules (fasted)
boceprevirAlso: SCH 503034Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.	Drug	Boceprevir Capsules then Tablets (fasted)

Primary outcome

Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State
Time frame: Predose through 72 hours post-dose
AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.
Maximum Plasma Concentration (Cmax) of Boceprevir Tablets Versus Capsules in Fed State
Time frame: Predose through 72 hours post-dose
Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.
AUCtf for Boceprevir Tablets Versus Capsules in Fasted State
Time frame: Predose through 72 hours post-dose
AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.
Cmax of Boceprevir Tablets Versus Capsules in Fasted State
Time frame: Predose through 72 hours post-dose
Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.
AUC From Hour 0 to Infinity (AUCinf) in Fed State
Time frame: Predose through 72 hours post-dose
AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.
AUCinf in Fasted State
Time frame: Predose through 72 hours post-dose
AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.
Half Life (t1/2) of Boceprevir in Fed State
Time frame: Predose through 72 hours post-dose
T1/2 is the time required for a given drug concentration to decrease by 50%.
t1/2 Boceprevir in Fasted State
Time frame: Predose through 72 hours post-dose
T1/2 is the time required for a given drug concentration to decrease by 50%.

Results and safety

Results posted to the registry on 18 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Boceprevir Tablets Then Capsules ( Fed)	30	30
Boceprevir Capsules Then Tablets ( Fed)	30	30
Boceprevir Tablets Then Capsules (Fasted)	0	0
Boceprevir Capsules Then Tablets (Fasted)	0	0

Primary outcome: Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State

Time frame: Predose through 72 hours post-dose. Geometric mean (90% Confidence Interval). Unit: ng*hr/mL

Measure	Boceprevir Tablets (Fed) n = 60	Boceprevir Capsules (Fed) n = 60
Value	7385 (6939 to 7859)	6644 (6243 to 7071)

Boceprevir Tablets (Fed): Least Squares Geometric Mean Ratio: 1.11 (90% CI 1.07 to 1.15), ANOVA

Population analysed: Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.

Primary outcome: Maximum Plasma Concentration (Cmax) of Boceprevir Tablets Versus Capsules in Fed State

Time frame: Predose through 72 hours post-dose. Geometric mean (90% Confidence Interval). Unit: ng*hr/mL

Measure	Boceprevir Tablets (Fed) n = 60	Boceprevir Capsules (Fed) n = 60
Value	2161 (1993 to 2343)	1515 (1394 to 1642)

Boceprevir Tablets (Fed) vs Boceprevir Capsules (Fed): Least Squares Geometric mean ratio: 1.43 (90% CI 1.32 to 1.54), ANOVA

Population analysed: Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.

Primary outcome: AUCtf for Boceprevir Tablets Versus Capsules in Fasted State

Time frame: Predose through 72 hours post-dose. Geometric mean (90% Confidence Interval). Unit: ng*hr/mL

Measure	Boceprevir Tablets (Fasted) n = 117	Boceprevir Capsules (Fasted) n = 117
Value	4329 (4109 to 4561)	3935 (3734 to 4146)

Boceprevir Tablets (Fasted) vs Boceprevir Capsules (Fasted): Least Squares Geometric mean ratio: 1.10 (95% CI 1.06 to 1.14), ANOVA

Population analysed: Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.

Primary outcome: Cmax of Boceprevir Tablets Versus Capsules in Fasted State

Time frame: Predose through 72 hours post-dose. Geometric mean (90% Confidence Interval). Unit: ng/mL

Measure	Boceprevir Tablets (Fasted) n = 117	Boceprevir Capsules (Fasted) n = 117
Value	1263 (1196 to 1333)	1103 (1044 to 1164)

Boceprevir Tablets (Fasted) vs Boceprevir Capsules (Fasted): Least Squares Geometric mean ratio: 1.15 (90% CI 1.09 to 1.21), ANOVA

Population analysed: Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Boceprevir Tablets (Fed)	0 of 60 (0%)	13 of 60 (21.7%)	Not reported
Boceprevir Capsules (Fed)	0 of 60 (0%)	6 of 60 (10%)	Not reported
Boceprevir Tablets (Fasted)	0 of 117 (0%)	7 of 117 (6%)	Not reported
Boceprevir Capsules (Fasted)	0 of 117 (0%)	5 of 117 (4.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing boceprevir in people with Hepatitis C, run by Merck Sharp & Dohme LLC.

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 44 inclusion and 39 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 7 Apr 2017. 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?

Yes. Results are posted in the registry (first posted 18 Apr 2012). 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?

Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State (time frame: Predose through 72 hours post-dose). The study lists 8 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 NCT01181804.

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 7 Apr 2017.