NA

• Register: EUCTR
• Last refreshed on: 28 August 2014
• Main ID: EUCTR2011-004159-38-BE
• Date of registration: 18/11/2011
• Prospective Registration: Yes
• Primary sponsor: Janssen R&D Ireland
• Public title: NA
• Scientific title: A Phase I, open label, randomized, crossover trial in healthy subjects to investigate the effect of steady-state TMC278 on the pharmacokinetics of a single dose of digoxin. - NA
• Date of first enrolment: 06/12/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004159-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Belgium

Contacts

• Name: Janssen Biologics BV
• Affiliation: Janssen-Cilag International N.V. - Clinical Registry Group

• Name: Janssen Biologics BV
• Affiliation: Janssen-Cilag International N.V. - Clinical Registry Group

Key inclusion & exclusion criteria

Inclusion criteria:
1. Men or women between 18 and 55 years of age, extremes included.
2. Men must agree to use a highly effective method of birth control (i.e., male condom with either female intrauterine device (IUD), diaphragm, cervical cap or hormone based contraceptives by their female partner) when having sexual intercourse with a female partner of childbearing potential, and to not donate sperm during the study and for 3 months after receiving the last dose of study drug.
Men who had a vasectomy and have a female partner of childbearing potential must agree to use a male condom during the study and for 3 months after receiving the last dose of study drug.
If the female sexual partner is postmenopausal for at least 2 years or is surgically sterile (has had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of becoming pregnant), she is not considered to be of childbearing potential and hence the birth control methods mentioned are not applicable.
Note: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction.
If a subject's partner becomes pregnant in the time between when the subject starts taking the study drug until 1 month after the last dose, the investigator must be informed immediately.
3. Women must:
- be postmenopausal for at least 2 years, OR
- be surgically sterile (have had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of
becoming pregnant).
4. Women must have a negative pregnancy test at screening.
5. Subjects must be non-smoking.
6. Subject must have a Body Mass Index (BMI) of 18.5 to 30.0 kg/m2, extremes included
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. A positive HIV-1 or HIV-2 test at screening.
2. Hepatitis A, B or C infection (confirmed by hepatitis A immunoglobulin (IgM), HBsAg, or hepatitis C virus antibody, respectively) at screening.
3. A positive urine drug test at screening or on Day -1 of Treatment A or on Day 1 of Treatment B. Urine will be tested for the presence of amphetamines, barbiturates,
benzodiazepines, cocaine, cannabinoids, methadone, and opioids.
Note: a positive test may be repeated once to exclude a technical error. Retesting will take place during the same visit. Subjects with a confirmed positive urine drug test at screening or on Day -1 of Treatment A or on Day 1 of Treatment B of Session 1 will be excluded.
4. Female subjects should not be breastfeeding.
5. Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrine, renal, hepatic, respiratory, inflammatory or infectious disease.
6. Currently significant diarrhea or gastric stasis that in the investigator’s opinion could influence drug absorption or bioavailability.
7. Less than 2 or 3 bowel movements on average per week.
8. Any history of significant skin disease such as but not limited to drug rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis or urticaria.
9. Previously demonstrated clinically significant allergy or hypersensitivity to the drug or any of the excipients of the drug administered in this study (i.e., TMC278, digoxin or digitalis preparations).
10. Use of concomitant medication, including over-the-counter (OTC) products, herbal medications, and dietary supplements .
11. Having previously participated in more than 1 study (single or multiple dose) with TMC125 (etravirine), TMC120 (dapivirine) and/or TMC278 (rilpivirine hydrochloride, formerly known as R278474) or having developed a rash, erythema or urticaria while participating in a study with the aforementioned compounds.
12. Received an investigational product (including investigational vaccines) or used an investigational medical device within 60 days before the planned start of treatment or currently enrolled in an investigational study.
13. History of clinically relevant heart rhythm disturbances.
14. History of idiopathic hypertrophic subaortic stenosis (IHSS, hypertrophic cardiomyopathy), AV block, ventricular tachycardia/ventricular fibrillation or family history of sudden cardiac death.
15. Wolff (Wolfe)-Parkinson-White (WPW) syndrome or any other clinically relevant abnormality on ECG on Day 1 of the first session.
NOTE: Investigators should ensure that all study enrollment criteria have been met at screening.
If a subject's status changes after screening but before first dose of study drug is given such that they now meet an exclusion criterion, they should be excluded from participation in the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

HIV-1 infection
MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Body processes [G] - Immune system processes [G12]

Intervention(s)

Product Name: TMC278 (as the hydrochloric salt)
Product Code: GFI-314585-CA-026/F006
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: rilpivirine hydrochloride
CAS Number: 700361-47-3
Current Sponsor code: TMC278 (as the hydrochloric salt)
Other descriptive name: R314585
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: Lanoxin
Product Name: Lanoxin 0,250 mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: DIGOXIN
CAS Number: 20830-75-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Primary Outcome(s)

Main Objective: To investigate the effect of steady-state TMC278 on the single dose PK of digoxin.

Secondary Objective: To determine the short-term safety and tolerability of coadministration of TMC278 and digoxin.

Primary end point(s):

Secondary ID(s)

TMC278IFD1001

Source(s) of Monetary Support

Janssen R&D Ireland