Phase 1 Completed N=60 Randomized Treatment

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)

Source: ClinicalTrials.gov NCT01181804 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2012

Primary outcomePrimary: Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State — 7385; 6644 ng*hr/mL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State	7385; 6644	—
PRIMARY Maximum Plasma Concentration (Cmax) of Boceprevir Tablets Versus Capsules in Fed State	2161; 1515	—
PRIMARY AUCtf for Boceprevir Tablets Versus Capsules in Fasted State	4329; 3935	—
PRIMARY Cmax of Boceprevir Tablets Versus Capsules in Fasted State	1263; 1103	—
PRIMARY AUC From Hour 0 to Infinity (AUCinf) in Fed State	7457; 6879	—
PRIMARY AUCinf in Fasted State	4534; 4119	—
PRIMARY Half Life (t1/2) of Boceprevir in Fed State	1.61; 1.46	—
PRIMARY t1/2 Boceprevir in Fasted State	5.33; 6.39	—

Eligibility Criteria

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,

gastr

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01181804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.