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TMC278

Phase 1

HIV Infections | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jun 27, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

TMC278 · 1 trial · 1 indication

Phase 1 1
NCT01288755TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and RaltegravirHIV Infections
COMPLETED24 Analytics
PHASE1COMPLETED
TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in exposure to TMC278 following co-administration with raltegravir and vice versa
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 Endpoints

Number of participants with adverse events as a measure of safety and tolerability - TMC278 and raltegravir.
97 to 99 days (until and including last safety follow-up visit)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALTMC278 One 25 mg tablet once daily for 11 days (TrtA and C)
002EXPERIMENTALRaltegravir One 400 mg tablet twice daily for 4 days (Trt B) and for 11 days (TrtC)

Interventions

NameTypeDescription
TMC278DRUGOne 25 mg tablet, once daily, for 11 days (TrtA and C)
RaltegravirDRUGOne 400 mg tablet, twice daily, for 4 days (Trt B) and for 11 days (TrtC)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

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 surg...

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Frequently asked questions about TMC278

What is TMC278 used for?

TMC278 is an investigational small molecule being studied for the treatment of HIV Infections. It is currently in Phase 1 clinical development. The drug is being evaluated for its potential role in managing HIV, though it is not yet approved and remains under investigation.

Who makes TMC278?

TMC278 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this investigational drug for HIV Infections, and it is currently in Phase 1 development.

What phase is TMC278 in?

TMC278 is in Phase 1 clinical development. It is an investigational drug for HIV Infections and has not been approved. One Phase 1 study has been completed, and the drug remains under evaluation in early-stage clinical research.

What clinical trials is TMC278 in?

TMC278 has one completed clinical trial, NCT01288755, titled "TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir." This Phase 1 study enrolled 24 participants and was a controlled, randomized trial in healthy volunteers.

What does TMC278 target?

TMC278 is a small molecule being studied for HIV Infections. Its specific molecular target has not been disclosed in available information. The drug is in Phase 1 development by Merck & Company, Inc., and its mechanism of action is not publicly detailed.