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)

Tracking Information
First Submitted Date ICMJE	August 12, 2010
First Posted Date ICMJE	August 13, 2010
Results First Submitted Date	March 23, 2012
Results First Posted Date	April 18, 2012
Last Update Posted Date	April 7, 2017
Study Start Date ICMJE	June 2010
Actual Primary Completion Date	December 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 23, 2012)	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%.
Original Primary Outcome Measures ICMJE; (submitted: August 12, 2010)	Plasma concentration measurement: Cmax [ Time Frame: 72 hours after administration of study drug ]Characterization of PK profile elements for both drug formulations; Plasma concentration measurement: AUCtf [ Time Frame: 72 hours after administration of study drug ]Characterization of PK profile elements for both drug formulations; Plasma concentration measurement: (AUC(I), if data allow). [ Time Frame: 72 hours after administration of study drug ]Characterization of PK profile elements for both drug formulations; Plasma concentration measurement: (t1/2 , if data allow). [ Time Frame: 72 hours after administration of study drug ]Characterization of PK profile elements for both drug formulations
Change History	Complete list of historical versions of study NCT01181804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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)
Official Title ICMJE	A Definitive Bioequivalence Study of a New Boceprevir (SCH 503034) Tablet Formulation Compared to the Current Capsule Form in Healthy Male and Female Subjects.
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Hepatitis C
Intervention ICMJE	Drug: boceprevir; Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.; Other Name: SCH 503034
Study Arms	Experimental: Boceprevir Tablets then Capsules (fed) 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. Intervention: Drug: boceprevir; Experimental: Boceprevir Capsules then tablets (fed) 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. Intervention: Drug: boceprevir; Experimental: Boceprevir Tablets then Capsules (fasted) 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. Intervention: Drug: boceprevir; Experimental: Boceprevir Capsules then Tablets (fasted) 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. Intervention: Drug: boceprevir
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 23, 2012)	177
Original Actual Enrollment ICMJE; (submitted: August 12, 2010)	60
Actual Study Completion Date	December 2010
Actual Primary Completion Date	December 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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 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: i. 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). ii. 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). iii. condom (male or female) with spermicide (when marketed within the country), iv. 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. Exclusion Criteria: 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 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01181804
Other Study ID Numbers ICMJE	P06992
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes Plan Description: 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
Responsible Party	Merck Sharp & Dohme Corp.
Study Sponsor ICMJE	Merck Sharp & Dohme Corp.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Merck Sharp & Dohme Corp.
Verification Date	March 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP