TMC278-TiDP15-C150: Trial to Examine Safety, Tolerability and Plasma Pharmacokinetics of Multiple Doses of TMC278LA.
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ClinicalTrials.gov Identifier: NCT00741741
The purpose of this study is: to determine the safety, (local) tolerability and plasma exposure over time of single intramuscular (IM) doses of 600 and 1200 mg of a new formulation (F006) of TMC278LA, to determine the safety, (local) tolerability and long-term plasma exposure over time of 2 dose regimens of 4 monthly IM doses of a new formulation (F006) of TMC278LA., To determine the safety, (local) tolerability and long-term plasma exposure over time of 1 dose regimen of 4 monthly subcutaneous (SC) doses of a new formulation (F006) of TMC278LA.
Safety, (local) tolerability and TMC278 PK of multiple doses of a novel formulation of TMC278LA throughout the study till WK24, WK28, WK32 or beyond WK32 (i.e. till TMC278 is below 20 ng/ml and till all AEs are resolved/stabilized)
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients aged between 18 and 55 years, extremes included
Non-smokers for at least 3 months prior to selection
Normal weight as defined by a Body Mass Index (BMI: weight in kg divided by height in meters squared) of 18.0 to 30.0 kg/m2, extremes included
Informed Consent Form signed voluntarily
Able to comply with protocol requirements
Normal 12-lead electrocardiogram (ECG) (in triplicate) at screening including: a) normal sinus rhythm (heart rate [HR] between 40 and 100 bpm), b) QTc interval <= 450 ms, c) QRS interval lower than 120 ms, d) PR interval <= 220 ms
Healthy on the basis of a pre-study physical examination, medical history, vital signs and the results of blood biochemistry and hematology tests and a urinalysis carried out at screening
Patient agrees not to participate in any other clinical trial until 6 weeks after being informed that his/her TMC278 exposure is below 20 ng/ml (all panels)
Females participating in the clinical study must be of non-childbearing potential (e.g. surgically sterilized or postmenopausal with no menstrual bleeding for at least 2 years prior the clinical study
If the patient is a sexually active man and not surgically sterilized, he must be willing to abstain from sexual intercourse, or use a condom plus another form of contraception (e.g., spermicide, IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant. This will avoid pregnancy caused by possibly damaged sperm. Males must use a condom during sexual intercourse with pregnant or lactating females. Male patients must not father a child from administration of the first dose and up to one month after the last dose of the IMP.
Past history of heart arrhythmias (extrasystolic, tachycardia at rest) or having baseline prolongation of QTc interval > 450 ms, history of risk factors for Torsade de Pointes syndrome (hypokalemia, family history of long QT Syndrome)
History or suspicion of alcohol, barbiturate, amphetamine, recreational or narcotic drug use that could impact compliance to protocol requirements and/or safety
Hepatitis A infection (confirmed by hepatitis A antibody), or hepatitis B infection (confirmed by hepatitis B surface antigen), or hepatitis C infection (confirmed by hepatitis C virus antibody) or HIV-1 or HIV-2 infection at screening
A positive urine drug test at study screening. Urine will be tested for the presence of amphetamines, benzodiazepines, cocaine, cannabinoids, opioids, methadone and barbiturates
Currently active or underlying gastro-intestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease
History of clinically relevant skin disease such as, but not limited to, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria
History of drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous clinical studies with experimental drugs
Use of concomitant medication, including over-the-counter products, herbal medication (including St. John's Wort) and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen in a period of 14 days before the first IMP administration
Participation in an investigational drug trial within 30 days prior to the first injection with IMP, Donation of blood or plasma in the 60 days preceding the injection with the IMP, Having previously participated in a clinical study with oral TMC278 (previously known as R278474) or TMC278LA, Vulnerable subjects (e.g., persons kept in detention)