Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT01396005
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) between 18 and 36, inclusive
* Reliable participation in a methadone maintenance or buprenorphine maintenance or buprenorphine/naloxone maintenance program for at least two (2) months prior to Day 1.
* Is receiving once daily oral dose of methadone therapy at a stable
individualized dose for at least 4 weeks, receiving once
daily buprenorphine dose at a stable individualized dose for at 4 weeks with, if on buprenorphine only therapy, naloxone added for at least 2 weeks prior to Day 1.
* 12-lead electrocardiogram (ECG) conduction intervals within gender-specific normal range
* Vital signs within normal range
* Clinical laboratory tests within normal range
* Women who are postmenopausal, surgically sterilized, or premenopausal and use a medically-accepted method of contraception.
Exclusion Criteria:
* Pregnancy, breast feeding, or intention to become pregnant or father a child while on study or within 3 months after end of trial
* History or presence of inflammatory bowel disease, ulcers, or 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
* History of urinary obstruction or difficulty in voiding
* 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
* Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
* Positive screen for drugs with a high potential for abuse such as cocaine, amphetamines, methylenedioxymethamphetamine (MDMA), barbiturates, benzodiazepines, or opiates/opioids
* Excessive use of alcohol in the 2 weeks prior to Day -1, defined as greater than 3 glasses of alcoholic beverages (1 is approximately equivalent to: beer \[284 mL/10 oz\], wine
\[125 mL/4 oz\], or distilled spirits \[25 mL/1 oz\]) per day.
* Blood donation in the past 60 days
* Previous administration of SCH 503034 (boceprevir)
* Current participation in another clinical study or participation in a clinical study (e.g., laboratory or clinical evaluation) within 30 days of baseline
* Study staff personnel or family members of the study staff personnel
* Demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) that, in the opinion of the investigator and sponsor, interfere with their ability to participate in the trial
* History of malignancy within 5 years from Screening
* Consumption of excessive amounts (equivalent to \> 6 cups of brewed coffee/day) of coffee, tea, cola or other caffeinated beverages
* Receipt of any of the following more recently than the washout period prior to Baseline: inhibitors or inducers of cytochrome (CYP) P450, CYP2B6, CYP3A4, and CYP2D6; or oral contraceptives containing drospirenone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01396005
Study Brief:
Protocol Section:
NCT01396005