Clinical trials: Rilpivirine
Healthy
A Single-Dose Pharmacokinetics and Safety Study of TMC278 in Healthy Adult Japanese Participants
The purpose of this study is to evaluate the pharmacokinetics and safety of TMC278 after a single oral dose of TMC278 25 mg tablet (27.5 mg as the hydrochloride salt) under fed conditions in healthy Japanese adult male…
- Trial name
- NCT01804244
- Testing
- TMC278
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Healthy Subject
A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers
This was a Phase 1, open-label, randomized, single center, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study between SACT-1 and Edurant® tablet.
- Trial name
- NCT05358756
- Testing
- SACT-1, EDURANT 25Mg Tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Aptorum International Limited
Healthy
A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants
The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics (what the medication does to the body) of TMC278…
- Trial name
- NCT01656018
- Testing
- TMC278, Long acting (LA)
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
HIV Infections
Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants
This is a phase 1, open label study in healthy participants to assess the pharmacokinetics of cabotegravir and rilpivirine in plasma following the administration of a single 600 milligram (mg) and a 900 mg intramuscular (IM)…
- Trial name
- NCT04371380
- Testing
- Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir extended release suspension for injection (long-acting)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Human Volunteers
TMC278-TiDP6-C152: A Study to Assess the Effects of TMC278 and Efavirenz (EFV) on the QT/QTc Interval (Heart Conduction and Heart Rhythm) in Healthy Volunteers.
This is a study to evaluate the effect of TMC278 25 mg daily on the QT/QTc interval (heart conduction and heart rhythm) in healthy volunteers.
- Trial name
- NCT00744809
- Testing
- TMC278; Moxifloxacin; Efavirenz
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatitis C, HIV
TMC125IFD1001 - Drug-Drug Interaction of Etravirine With Telaprevir and TMC278 With Telaprevir.
The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed into the body when administered together.
- Trial name
- NCT01336829
- Testing
- ETR/telaprevir, TMC278/telaprevir, telaprevir/ETR
- Where
- Belgium
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections
TMC278-TiDP15-C158 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of a Single Dose or Three Successive Doses of Intramuscularly (IM) Injected Long Acting Formulation of TMC278
The purpose of this study is to examine the safety, local tolerability and pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of a…
- Trial name
- NCT01031589
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Healthy
A Study to Explore the Pharmacokinetics of Rilpivirine With Rifabutin in Healthy Participants
The purpose of this study is to explore the pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin in healthy participants.
- Trial name
- NCT01615614
- Testing
- Rilpivirine, Rifabutin
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Infection, Human Immunodeficiency Virus
Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy Subjects
Treatment of human immunodeficiency virus (HIV) infection requires daily oral administration of a combination of antiretroviral drugs to reduce the patient's HIV levels.
- Trial name
- NCT02373930
- Testing
- DTG 50 mg, RPV 25 mg, DTG/RPV 50 mg/25 mg: Product Code AS
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Hepatitis C Virus
TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and Tenofovir
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 on the steady-state pharmacokinetics of TMC278 or Tenofovir , and vice versa.
- Trial name
- NCT01205139
- Testing
- TMC435, TDF, TMC435 + TDF
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV-1
TMC278-TiDP15-C150: Trial to Examine Safety, Tolerability and Plasma Pharmacokinetics of Multiple Doses of TMC278LA.
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…
- Trial name
- NCT00741741
- Testing
- TMC278
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV, AIDS
TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.
The purpose of this study is to investigate the pharmacokinetic interaction between the combination of ethinylestradiol and norethindrone and TMC278 25 mg once daily.
- Conditions
- HIV, AIDS, Oral Contraceptive
- Trial name
- NCT00739622
- Testing
- TMC278
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV
TMC278-TiDP6-C121: Drug-drug Interaction Trial to Investigate the Potential Interaction Between TMC278 25 mg Daily and Methadone, at Steady State.
The purpose of this Phase I, open-label, single-sequence drug-drug interaction trial in patients on stable methadone maintenance therapy is to investigate the potential interaction between TMC278 25 mg daily and methadone, at…
- Trial name
- NCT00744770
- Testing
- TMC278
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Infections, Human Immunodeficiency Virus and Hepatitis
A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects
This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects.
- Trial name
- NCT01467531
- Testing
- Dolutegravir, Rlipivirine, GSK1265744
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy
A Study to Investigate the Effect of Steady-State TMC278 on the Pharmacokinetics of a Single Dose of Digoxin
The purpose of this study is to investigate the effect of steady-state (constant concentration of medication in the blood) TMC278 on the single dose pharmacokinetics (what the body does to the medication) of digoxin.
- Trial name
- NCT01519128
- Testing
- Treatment A: Digoxin, Treatment B: TMC278
- Where
- Belgium
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Healthy
A Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration in Healthy Japanese Adult Male Participants
The purpose of this study is to evaluate the pharmacokinetics (PK) of rilpivirine/Tenofovir/Emtricitabine (RPV/TFV/FTC) after a single-oral administration of Complera (the fixed-dose combination of RPV, FTC, Tenefovir disoproxil…
- Trial name
- NCT02530060
- Testing
- Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDC
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
HIV Infections
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter…
- Trial name
- NCT05418868
- Testing
- Cabotegravir 200 mg/mL, CAB >=400 mg/mL, CAB Formulation I
- Where
- 3 sites in United States
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections in Healthy Adult Subjects
LAI115428 is a Phase I, randomized, repeat dose escalation study to determine the safety, tolerability, and PK profile of intramuscular and subcutaneous injections of GSK1265744 in a long acting parenteral (LAP) formulation in…
- Trial name
- NCT01593046
- Testing
- GSK1265744 Oral, GSK1265744 LAP 800mg intramuscular injection, GSK1265744 LAP 200mg subcutaneous injection
- Where
- 2 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent
Dolutegravir (DTG), a human immunodeficiency virus (HIV)-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are each approved in the United States (US), European…
- Trial name
- NCT03984838
- Testing
- JULUCA (Dolutegravir and Rilpivirine) 50mg/25mg FDC tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy
A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Rilpivirine Tablets (RPV)
Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance.
- Trial name
- NCT07001488
- Testing
- Azvudine tablets(FNC) and Rilpivirine Tablets (RPV), Azvudine tablets (FNC) and Rilpivirine Tablets (RPV)
- Where
- China
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Henan Genuine Biotech Co., Ltd.