Clinical trials: Cytochrome P-450 Enzyme System
Liver Cirrhosis
In Vivo Determination of Cytochrome P450 Activities in Patients With Liver Cirrhosis
Subjects will receive the "Basel phenotyping cocktail" capsule orally with 120-200ml tap water in fasted state. After intake peripheral venous blood samples will be drawn.
- Trial name
- CombiCapsLC (NCT03337945)
- Testing
- "Basel phenotyping cocktail" capsule
- Where
- Switzerland
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Crohn's Disease
A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects
The purpose of this study is to test the effects of study drug (GSK1605786) on the blood levels of multiple commonly used drugs that are given to measure how your liver breaks down the study drug.
- Trial name
- NCT01489943
- Testing
- GSK1605786 500 mg, Midazolam 3 mg, Pioglitazone 15 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections
Optimizing Antiretroviral Therapy in HIV-Infected Children and Adolescents
This was a feasibility study aimed at elevating protease inhibitors (PI) dosage as a part of active antiretroviral therapy (HAART).
- Trial name
- NCT00207948
- Testing
- Dose adjustment of Kaletra
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Children's National Research Institute
Type 2 Diabetes
Evaluation of CYP450 Activities in Diabetic Patients vs. Non-diabetic Subjects
Type 2 diabetes (T2D) could modulate CYP450 activities involved in drug-metabolism and cardiovascular homeostasis. We propose to carry out, for the first time, a comprehensive characterization of the effects of T2D on the…
- Trial name
- NCT02291666
- Testing
- CRCHUM-MT cocktail
- Where
- Canada
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Rheumatoid Arthritis
Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin
Drug-drug interaction study in healthy men and women not of childbearing potential. Assess the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and…
- Trial name
- NCT03131973
- Testing
- BMS-986195, Methotrexate, Leucovorin
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
B-Cell Chronic Lymphocytic Leukemia
Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy
The purpose of this study is to assess the effect of a moderate Cytochrome P450 (CYP) 3A inhibitor (erythromycin) and a strong CYP3A inhibitor (voriconazole) on the steady-state pharmacokinetics (PK [the study of the way a drug…
- Trial name
- NCT02381080
- Testing
- Ibrutinib, Erythromycin, Voriconazole
- Where
- 6 sites in Canada, Russia and 1 more
- Volunteers
- 26 people
- Sponsor
- Janssen Research & Development, LLC
Atopic Dermatitis
Open Label, Drug-Drug Interaction (DDI) Study of Dupilumab (REGN668/SAR231893) in Patients With Moderate to Severe Atopic Dermatitis (AD)
This is an open-label, single-sequence DDI study designed to examine the effects of dupilumab on the pharmacokinetics of selected cytochrome P450 substrates in adult patients with moderate to severe AD.
- Trial name
- NCT02647086
- Testing
- Dupilumab, Midazolam, Omeprazole
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Regeneron Pharmaceuticals
Crohn Disease, Ulcerative Colitis
A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis
The purpose of this study is to evaluate the potential effects of an intravenous (IV) induction and subcutaneous (SC) maintenance administration of ustekinumab on the pharmacokinetic (PK) of a cocktail of representative probe…
- Trial name
- NCT03358706
- Testing
- Ustekinumab IV Infusion, Ustekinumab SC Injection, Midazolam 2 mg
- Where
- 16 sites in United States, Belgium and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hormone Receptor-Positive Breast, Gynecologic
Endoxifen in Adults With Hormone Receptor Positive Solid Tumors
Background: Some types of cancer cells that have hormone receptors on their surfaces need the hormone estrogen to grow. The drug tamoxifen blocks estrogen from binding to the tumor cells, which helps to slow or stop the growth of…
- Conditions
- Hormone Receptor-Positive Breast, Gynecologic, Desmoid, Hormone Receptor-Positive Neoplasms
- Trial name
- NCT01273168
- Testing
- Z-Endoxifen
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- National Cancer Institute (NCI)
Liver Cirrhosis
A Study to Compare How Different Substances (Caffeine, Warfarin, Omeprazole, Metoprolol, and Midazolam) Are Handled by the Body of Healthy People and People With Liver Cirrhosis
This study is open to healthy adults and adults with liver cirrhosis. The purpose of this study is to compare how different medicines are handled by the body in people with and without liver cirrhosis.
- Trial name
- NCT05741385
- Testing
- Caffeine, Warfarin sodium, Omeprazole
- Where
- Germany
- Volunteers
- 4 people
- Sponsor
- Boehringer Ingelheim
Substance-Related Disorders
Role of CYP2B6, CYP3A4, and MDR1 in the Metabolic Clearance of Methadone
The purpose of this study is to determine to what extent CYP2B6, CYP3A4, and MDR1 polymorphisms affect the metabolism of methadone.
- Trial name
- NCT00504413
- Testing
- midazolam(drug), digoxin (drug), Bupropion (drug), Methadone (drug)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Washington
Wilson Disease
Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.
This was a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of celecoxib, a sensitive cytochrome P450 2C9 (CYP2C9) substrate, in healthy male and female…
- Trial name
- NCT04526197
- Testing
- ALXN1840, Celecoxib
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Gastrointestinal Neoplasms, Genitourinary Cancer
Immune Checkpoint Inhibitor (ICI)-Drug-Drug Interaction (DDI) Study
Immune checkpoint inhibitors (ICIs) (also called "immunotherapy") are an effective family of anti-cancer drugs, but they can cause serious side effects.
- Conditions
- Gastrointestinal Neoplasms, Genitourinary Cancer, Thoracic Cancer, Sarcoma
- Trial name
- NCT07389525
- Testing
- ICI Therapy
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Indiana University
Metabolism
Effect of Genetics on Metabolism of Efavirenz
This study will evaluate the effects of genetics on metabolism of the anti-HIV medicine efavirenz (Sustiva) and will see if Efavirenz interacts with bupropion (Zyban or Wellbutrin), a drug commonly used to treat depression and to…
- Trial name
- NCT00245986
- Testing
- Blood draw
- Where
- United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- National Institutes of Health Clinical Center (CC)
Anovulation, Disorder Due Cytochrome P450 CYP2D6 Variant
Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.
- Conditions
- Anovulation, Disorder Due Cytochrome P450 CYP2D6 Variant, Cytochrome P450 CYP3A Enzyme Deficiency
- Trial name
- NCT01289756
- Testing
- Clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Acute Ischemic Stroke
Clopidogrel Preventive Effect Based on CYP2C19 Genotype in Ischemic Stroke
The hypothesis of this study is that "the poor metabolizer or intermediate metabolizer of the cytochrome P450 2C19 genotype in patients with acute ischemic stroke is associated with increased risk of composite cardiovascular…
- Trial name
- NCT04072705
- Testing
- General principles of care and judgement of researcher
- Where
- 37 sites in South Korea
- Volunteers
- 2,927 people
- Sponsor
- Gangnam Severance Hospital
Colitis, Ulcerative, Crohn Disease
Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study
The purpose of this study is to evaluate in a step-wise approach the disease drug-drug interaction (DDI) potential for vedolizumab to indirectly affect the exposure of cytochrome P-450 (CYP) substrate drugs by modulating…
- Trial name
- NCT02760615
- Testing
- Caffeine, Losartan, Omeprazole
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Takeda
Sleep Apnea
Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea
The purpose of this research study is to determine the effect of chronic nighttime low oxygen saturations on selected body systems (liver) that break down drugs in children with obstructive sleep apnea syndrome (OSAS).
- Trial name
- NCT00310323
- Testing
- Dextromethorphan, Caffeine
- Where
- 2 sites in United States
- Volunteers
- 69 people
- Sponsor
- Virginia Commonwealth University
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Coronavirus Disease 2019 (COVID-19)
A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People With Weakened Immune Systems or at Increased Risk for Poor Outcomes Who Are Hospitalized Due to Severe COVID-19
A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People with Weakened Immune Systems or at Increased Risk for Poor Outcomes who are Hospitalized Due to Severe COVID-19
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Coronavirus Disease 2019 (COVID-19), Immunocompromised, Hospitalization
- Trial name
- EPIC-HOS (NCT05545319)
- Testing
- Nirmatrelvir, Ritonavir
- Where
- 11 sites in United States, Bulgaria
- Sponsor
- Pfizer
Inflammation
Impact of Acute and Chronic Inflammation on Cytochromes P450 Activity Measured With Dried Blood Spot
Cytochromes P450, main enzymes of drug metabolism, play a prominent role in the first-pass metabolism of oral substances. Inter-individual variability in their activity due to genetic and environmental factors has been observed…
- Trial name
- NCT03262051
- Testing
- CYP phenotyping
- Where
- Switzerland
- Volunteers
- 106 people
- Sponsor
- University Hospital, Geneva