- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01288755
TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir
June 23, 2011 updated by: Tibotec Pharmaceuticals, Ireland
A Phase I, Open-label, Randomized, Crossover Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC278 25 mg q.d. and Raltegravir 400 mg b.i.d.
The purpose of this study is to investigate the effect of steady-state concentrations of raltegravir (administered as 400 mg, twice daily) on the steady-state pharmacokinetics of TMC278 (25 mg, once daily), and vice versa.
Steady state is a term that means that the drug has been given long enough so that the plasma levels will remain at about the same level with each subsequent dose.
TMC278 is being investigated for the treatment of human immunodeficiency virus (HIV) infection.
Raltegravir is a commercially available antiretroviral drug for treatment of HIV infection.
Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
Study Overview
Detailed Description
TMC278 is being investigated for treatment of HIV infection.
Raltegravir is a commercially available HIV drug.
The results of this study will provide dosing recommendations for coadministration of TMC278 and raltegravir in HIV-infected patients.
This is a Phase I, open-label (both participant and investigator know the name of the medication given at a certain moment), randomized (sequence of treatment with study medications is assigned by chance), crossover trial in 24 healthy volunteers to investigate the pharmacokinetic interaction between TMC278 and raltegravir, at steady state.
The study will consist of 3 phases: a screening phase, an open-label treatment phase consisting of 2 treatment periods, and end-of-study or withdrawal assessments.
The duration of participation in the study for an individual participant will be up to 3 months (including screening).
All participants will be randomly assigned to 1 of 2 possible treatment sequences and receive the following 2 treatments (Trt-s): TMC278 25 mg, once daily, alone for 11 days (TrtA), and raltegravir 400 mg, twice daily, alone for 4 days immediately followed by coadministration of the same raltegravir dose plus TMC278 25 mg, once daily, for 11 days (TrtB+C).
There will be a washout period (a period where no study drug will be taken in view of having all the medication eliminated from the body before starting a new treatment) of at least 14 days between last intake of study medication in one session and first intake of study medication in the subsequent session.
Pharmacokinetic profiles of both compounds will be determined through blood samples taken at regular intervals during the study.
Safety and tolerability will be assessed during the study period and in follow-up.
Blood and urine samples, electrocardiogram (ECG) and vital signs (blood pressure and heart rate) will be taken at screening, before medication intake in TrtA on Days 1, 11, and 12 (Day 12 is without ECG), in TrtB+C on Days 1, 4, 5, 15, and 16 (Day 16 is without ECG) and at the 2 follow-up visits (but without ECG) at 1 week and 4 weeks after last dose of study medication in the last session.
A physical examination will be performed at screening, on Days 10 and 12 of TrtA, on Days 3, 14, and 16 of TrtB+C, and at both follow-up visits.
Healthy volunteers will stay overnight in the study center for 3 nights in TrtA and for 5 nights in TrtB+C.
Each volunteer will receive in a randomized order 2 treatments, minimum 14 days apart from each other.
TrtA is TMC278 25 mg, once daily, for 11 days.
TrtB+C is raltegravir 400 mg, twice daily, alone for first 4 days (TrtB) followed by coadministration of 400 mg raltegravir, twice daily, and TMC278 25 mg, once daily, on Days 5 to 15 (TrtC).
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy, based on physical examination, medical history, vital signs, ECG, blood biochemistry, hematology and urinalysis
- Body Mass Index of 18 to 30.0 kg/m2
- Non-smoking for at least 3 months prior to screening
- Women must be postmenopausal for at least 2 years, or be surgically sterile.
Exclusion Criteria:
- Infected with Hepatitis A, B, or C Virus
- Infected with human immunodeficiency virus (HIV)
- History of clinically relevant hearth rhythm disturbances
- Having previously participated in more than 1 study with raltegravir, TMC125, TMC120 and/or TMC278 or having developed rash, erythema or urticaria while participating in a trial with aforementioned compounds
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
TMC278 One 25 mg tablet once daily for 11 days (TrtA and C)
|
One 25 mg tablet, once daily, for 11 days (TrtA and C)
|
Experimental: 002
Raltegravir One 400 mg tablet twice daily for 4 days (Trt B) and for 11 days (TrtC)
|
One 400 mg tablet, twice daily, for 4 days (Trt B) and for 11 days (TrtC)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in exposure to TMC278 following co-administration with raltegravir and vice versa
Time Frame: Measured on Days 5, 12, 13, 14, 15, and 16 (TrtC). Reference for exposure to raltegravir only (TrtB), measured on Days 1, 2, 3, and 4. Reference for exposure to TMC278 only (TrtA), measured on Days 1, 8, 9, 10, 11, and 12.
|
Measured on Days 5, 12, 13, 14, 15, and 16 (TrtC). Reference for exposure to raltegravir only (TrtB), measured on Days 1, 2, 3, and 4. Reference for exposure to TMC278 only (TrtA), measured on Days 1, 8, 9, 10, 11, and 12.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events as a measure of safety and tolerability - TMC278 and raltegravir.
Time Frame: 97 to 99 days (until and including last safety follow-up visit)
|
97 to 99 days (until and including last safety follow-up visit)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
January 7, 2011
First Submitted That Met QC Criteria
February 1, 2011
First Posted (Estimate)
February 2, 2011
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 23, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- HIV Integrase Inhibitors
- Integrase Inhibitors
- Raltegravir Potassium
- Rilpivirine
Other Study ID Numbers
- CR017773
- TMC278-TiDP6-C153
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on TMC278
-
Tibotec Pharmaceuticals, IrelandCompleted
-
Janssen Research & Development, LLCCompleted
-
Tibotec Pharmaceuticals, IrelandCompletedHepatitis C | HIVBelgium
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
University of California, San FranciscoNational Cancer Institute (NCI)Unknown
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)CompletedLymphoma | Leukemia | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
ViiV HealthcareGlaxoSmithKlineCompletedInfection, Human Immunodeficiency VirusUnited States
-
Tibotec Pharmaceuticals, IrelandCompletedHuman Immunodeficiency Virus Type 1United States, France, United Kingdom, China, Germany, South Africa, Russian Federation, Argentina, Brazil, Puerto Rico, Austria, Thailand, Mexico, Uganda
-
Janssen R&D IrelandCompleted
-
Janssen Research & Development, LLCCompletedHIVItaly, Thailand, Spain, Uganda, Portugal, South Africa