25 completed, 4 terminated, 1 recruiting. 30 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 30 | Completed 25, Terminated 4, Recruiting 1 |
| Phase 2 | 2 | Completed 1, Recruiting 1 |
Follow Cobicistat: new trials by email Literature Review of Cobicistat trials Research Report on Cobicistat
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| KF2024#1-trial: Esketamine Interaction Study Esketamine Nasal Spray, Esketamine 28 mg, Cobicistat 150 MG - Drug Interactions, Food-drug Interaction | Phase 1 | Completed | Helsinki University Central Hospital | 12 | 2024-12-09 | 2026-03-05 |
| A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants. Plixorafenib, Cobicistat - Healthy Participants | Phase 1 | Completed | Fore Biotherapeutics | 28 | 2024-04-24 | 2026-03-27 |
| Electrophysiological Effects of Potential QT Prolonging Drugs Clarithromycin, Pimozide, Placebo (Part 1) - Drug-induced QT Prolongation, Pharmacokinetics | Phase 1 | Completed | Food and Drug Administration (FDA) | 44 | 2023-03-21 | 2023-06-22 |
| A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients with Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma Cobicistat Oral Tablet, Gemcitabin, Nab paclitaxel - CYP3A Inhibitor, Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma | Phase 1 | Terminated | German Cancer Research Center | 6 | 2022-12-07 | 2025-03-25 |
| A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers PBI-200 Tablet, Ritonavir Oral Tablet, Cobicistat Oral Tablet - Drug-drug Interaction | Phase 1 | Completed | Pyramid Biosciences | 21 | 2022-09-09 | 2023-01-20 |
| Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels Vesatolimod, Cobicistat, Voriconazole - Human Immunodeficiency Virus Type 1 (HIV-1) Infection | Phase 1 | Terminated | Gilead Sciences | 18 | 2022-08-19 | 2024-12-03 |
| A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions Atazanavir, Cobicistat, Atazanavir/Cobicistat Mini-tablet - Healthy Participants | Phase 1 | Completed | Bristol-Myers Squibb | 42 | 2022-05-13 | 2022-10-31 |
| A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions Darunavir, Cobicistat, Darunavir/Cobicistat FDC - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 22 | 2021-01-26 | 2025-02-03 |
| A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC, Darunavir, Emtricitabine/Tenofovir Alafenamide - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 37 | 2021-01-05 | 2025-02-03 |
| A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time Atazanavir/Cobicistat, Reyataz Atazanavir, Cobicistat - Healthy Participants | Phase 1 | Completed | Bristol-Myers Squibb | 34 | 2020-02-26 | 2021-11-23 |
| Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat Cobicistat 150 MG, Placebo, GHB - Pharmacokinetic Interactions, HIV | Phase 1 | Completed | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | 12 | 2020-01-30 | 2020-07-22 |
| A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC, Darunavir, Emtricitabine/Tenofovir Alafenamide - Healthy | Phase 1 | Terminated | Janssen Pharmaceutica N.V., Belgium | 16 | 2020-01-23 | 2020-07-07 |
| A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation revumenib, cobicistat - Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia | Phase 1 / Phase 2 | Recruiting | Syndax Pharmaceuticals | 447 | 2019-11-05 | 2026-10-09 |
| Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Health Volunteers Cobicistat, Darunavir/Cobicistat, Rivaroxaban - Healthy Volunteers | Phase 1 | Completed | National Institutes of Health Clinical Center (CC) | 12 | 2019-06-04 | 2023-12-01 |
| Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Considered for Future On-demand Peri-exposure HIV Prophylaxis Regimens Genvoya - HIV/AIDS | Phase 1 | Completed | Emory University | 41 | 2019-03-13 | 2021-08-13 |
| ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer CPI-1205, Cobicistat, Enzalutamide - Metastatic Castration Resistant Prostate Cancer (mCRPC) | Phase 1 / Phase 2 | Completed | Constellation Pharmaceuticals | 175 | 2017-11-15 | 2025-10-29 |
| Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants Darunavir (DRV), Cobicistat (COBI), Emtricitabine (FTC) - Healthy | Phase 1 | Completed | Janssen Scientific Affairs, LLC | 30 | 2016-12-01 | 2025-02-03 |
| Pharmacokinetic Effect of Evotaz/Microgynon Co-administration Microgynon 30®, Evotaz® - HIV | Phase 1 | Terminated | St Stephens Aids Trust | 13 | 2016-07-01 | 2018-01-02 |
| First-in-Human Study of an Oral Plasmodium Falciparum Plasma Membrane Protein Inhibitor SJ733, Cobicistat - Malaria | Phase 1 | Completed | St. Jude Children's Research Hospital | 44 | 2016-03-01 | 2019-01-02 |
| THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC Maraviroc (Part 1), Maraviroc (Part 2), Darunavir/cobicistat (Part 2) - Healthy Subjects | Phase 1 | Completed | ViiV Healthcare | 47 | 2015-11-06 | 2017-04-17 |
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Acquired Immunodeficiency Syndrome (7) · Infections (2) · Neoplasms (2) · Adenocarcinoma (1) · Carcinoma (1) · Chemsex (1) · Hemorrhage (1) · Hepatitis C (1) · Leukemia (1) · Leukemia, Biphenotypic, Acute (1) · Leukemia, Myeloid, Acute (1) · Malaria (1) · Neoplasms by Histologic Type (1) · Neoplasms, Glandular and Epithelial (1) · Pancreatic Neoplasms (1)
Bristol-Myers Squibb (4) · St Stephens Aids Trust (3) · Janssen Research & Development, LLC (2) · Janssen Sciences Ireland UC (2) · National Institutes of Health Clinical Center (CC) (2) · ViiV Healthcare (2) · Constellation Pharmaceuticals (1) · Emory University (1) · Food and Drug Administration (FDA) (1) · Fore Biotherapeutics (1) · Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia (1) · German Cancer Research Center (1) · Gilead Sciences (1) · Helsinki University Central Hospital (1) · Janssen Pharmaceutica N.V., Belgium (1)
United States (17) · Netherlands (5) · Belgium (3) · United Kingdom (3) · Germany (2) · Spain (2) · Australia (1) · Canada (1) · Finland (1) · France (1) · Israel (1) · Italy (1) · Lithuania (1) · Puerto Rico (1)
Colleen M Hadigan, M.D. (2) · Marta Boffito (2) · Aditya H. Gaur, MD (1) · Angela R Smith, M.D. (1) · Colleen Kelley, MD (1) · David Burger, PharmD, PhD (1) · Janne T Backman, MD, PhD (1)
PMID 30412360, PMID 25361436, PMID 27798211, PMID 28848011, PMID 30192390, PMID 32275867, PMID 33741715, PMID 34267079, PMID 34561695, PMID 35315687, PMID 35598441, PMID 36922593, PMID 37335552, PMID 37920921, PMID 39121437, PMID 39909979, PMID 40332046, PMID 40952649, PMID 41621809
2019 (3), 2015 (2)