PEPI-TiDP23-C104 is a First in Human Study With a Single Dose Escalation Part and a Multiple Dosing Part for Compounds TMC589337 and TMC589354.
This study has been terminated.
(The premature end of this trial was a business decision and not due to safety or efficacy concerns of the compounds.)
Information provided by:
Tibotec Pharmaceuticals, Ireland
First received: May 21, 2009
Last updated: April 26, 2010
Last verified: April 2010
The purpose of the study is to determine the safety, tolerability, and plasma pharmacokinetics (i.e., the levels of TMC589337 and TMC589354 circulating in your blood over time) of increasing single oral doses of TMC589337 and TMC589354 and of multiple increasing oral doses followed by a single dose of TMC310911 to assess the potential boosting effect on the latter compound. In this study 3 investigational new drugs are involved. These new investigational drugs called TMC589337 and TMC589354 (from the PEPI family) and TMC310911 are in process of development for the treatment of Human Immunodeficiency Virus-Type 1 (HIV-1). TMC589337 and TMC589354 are novel molecules with no antiviral activity to be used to enhance the pharmacokinetics profile of a drug. TMC310911 is a novel and potent compound and belong to a medication class called protease inhibitors (PI).
Drug: TMC589337, TMC589354, TMC310911, placebo
Primary Purpose: Treatment
||Phase I, Double-blind, Randomized, Placebo-controlled Trial in Healthy Volunteers to Examine Safety, Tolerability, Plasma Pharmacokinetics of TMC589337&TMC589354 After Increasing Single Oral Doses & in an Open-label Part After Different Repeated Doses in Combination With Single Oral Dose of TMC310911
Primary Outcome Measures:
- The trial objectives are to determine the safety, tolerability and plasma pk of TMC589337/TMC589354 after increasing single oral doses from 40 mg up to 400 mg and after increasing multiple oral doses. [ Time Frame: 8 weeks. This includes a treatment, washout and follow up period and is excluding screening period of maximum 21 days before first medication intake) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The trial objectives are to determine the safety, tolerability and plasma pk interaction between TMC310911 and TMC589337 or TMC589354. [ Time Frame: 8 weeks. This includes a treatment, washout and follow up period and is excluding screening period of maximum 21 days before first medication intake) ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2009 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Nonsmokers for at least 3 months prior to selection
- Weight as defined by a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
- Informed Consent Form (ICF) signed voluntarily
- Able to comply with protocol requirements
- Healthy on the basis of a pretrial physical examination, medical history, the results of blood biochemistry and hematology tests, a urinalysis, vital signs, and a 12-lead electrocardiogram (ECG).
- Past history of clinically significant heart arrhythmias (extrasystolic, tachycardia at rest)
- having baseline prolongation of QTc interval > 450 ms, history of risk factors for Torsade de Pointes syndrome (hypokalemia, family history of long QT Syndrome)
- Female, except if postmenopausal for more than 2 years, or posthysterectomy or postsurgical sterilization (without reversal operation)
- Currently active clinically relevant or significant underlying gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease
- History of clinically relevant skin disease or allergy including drug allergy as well.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908414
Tibotec Pharmaceuticals, Ireland
||Tibotec Pharmaceuticals Limited Clinical Trial
||Tibotec Pharmaceutical Limited
No publications provided
||Compound Development Team Leader, Tibotec Pharmaceuticals Limited, Ireland
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 21, 2009
||April 26, 2010
||Ireland: Irish Agriculture and Food Development Authority
Keywords provided by Tibotec Pharmaceuticals, Ireland:
ClinicalTrials.gov processed this record on May 26, 2015