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)

NCT01181804 | Completed Phase 1 Results

• 1 other identifier: P06992
• Study Type: interventional
• Target: 177
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C

Keywords

boceprevir; hepatitis C; bioequivalence; SCH 503034

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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%.

  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%.

  Predose through 72 hours post-dose

Study Arms (4)

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.

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.

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.

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.

Drug: boceprevir

Interventions

boceprevir DRUG

Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.

Also known as: SCH 503034

Boceprevir Tablets then Capsules (fed)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Female subjects who are pregnant, intend to become pregnant (within
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Vice President, Late Stage Development Group Leader
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 7, 2017
• Results First Posted: April 18, 2012

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share