Clinical trials: Cytochrome P-450 Enzyme System
Diabetes
Pharmacokinetics of Antiplatelet Drugs in Diabetic pAtients
Clopidogrel efficacy appears diminished in patients with type 2 diabetes (T2D) who continue to show an increased risk of adverse cardiovascular events and mortality compared to those without T2D.The aim of the first project is to…
- Trial name
- PANDDA (NCT02302508)
- Testing
- Clopidogrel, Prasugrel, Ticagrelor
- Where
- Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Parkinson Disease
Study to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Inducer Carbamazepine on Tavapadon Pharmacokinetics in Healthy Adult Participants
The primary purpose of this study is to evaluate the effect of carbamazepine, a strong CYP3A4 inducer, on the steady-state pharmacokinetics (PK) of tavapadon in healthy adult participants.
- Trial name
- NCT05581823
- Testing
- Tavapadon, Carbamazepine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Cerevel Therapeutics, LLC
Inhibition, Induction
Pharmacokinetic Interactions of Metamizole (Dipyrone) in Healthy Subjects
Investigators conducted a single center, two-phased, open, controlled pharmacokinetic study to investigate the drug-drug interaction potential of metamizole. For this reason, healthy male volunteers were screened.
- Conditions
- Inhibition, Induction, Drug-Drug Interaction
- Trial name
- NCT03990129
- Testing
- Metamizole
- Where
- Switzerland
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Wilson Disease
Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants
This is a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of bupropion, a sensitive cytochrome P450 2B6 (CYP2B6) substrate, in healthy male and female…
- Trial name
- NCT04526210
- Testing
- ALXN1840, Bupropion Hydrochloride
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
Hereditary Angioedema
An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates
This is an open-label, single sequence study to evaluate the effect of BCX7353 on hepatic and intestinal cytochrome P450 enzymes using probe substrate drugs in healthy subjects.
- Trial name
- NCT02819102
- Testing
- BCX7353 and probes
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- BioCryst 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
Hypogonadism
CYP19A1 (Cytochrome P450 Family 19 Subfamily A Member 1) Gene and Pharmacogenetics of Response to Testosterone Therapy
Testosterone (T) replacement prevents bone loss and relieves symptoms associated with androgen deficiency in male patients with hypogonadism, but at the expense of an increase in prostate-related adverse events and in the…
- Trial name
- NCT01378299
- Testing
- Testosterone Cypionate
- Where
- 2 sites in United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
HIV Infections
Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone
The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.
- Trial name
- NCT00362726
- Testing
- Rosiglitazone maleate, Atazanavir Sulphate, Atazanavir Sulphate + Rosiglitazone maleate
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Pain
Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers
This study evaluates the analgesic effect of Omnitram and tramadol during concurrent administration of paroxetine. Paroxetine administration is expected to diminish the analgesic effect of tramadol, but not Omnitram.
- Trial name
- NCT03312777
- Testing
- Omnitram, Tramadol
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Syntrix Biosystems, Inc.
Healthy
Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered
The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of…
- Trial name
- NCT00966966
- Testing
- SAM-531 and gemfibrozil
- Where
- Netherlands
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
A Study to Assess Effects of Clarithromycin on Pharmacokinetics of JNJ-54861911 in Healthy Male Participants
The purpose of this study is to assess the effects of strong cytochrome P450 (CYP) 3A4 inhibitors (Itraconazole and Clarithromycin), on pharmacokinetics (PK) (study of the way a drug enters and leaves the blood and tissues over…
- Trial name
- NCT02197884
- Testing
- JNJ-54861911, 25 mg, Itraconazole 200 mg, Clarithromycin 500 mg
- Where
- Belgium
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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)
Hepatic Cirrhosis
Evaluation of the PK of NRL972 Following Pre- and co-Administration of Ursodeoxycholic Acid and Cloxacillin
A study in healthy volunteers to determine whether different drugs metabolised by the liver have any effects on how NRL972 is processed within the body.
- Trial name
- NCT00857480
- Testing
- NRL972
- Where
- Bulgaria
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Norgine
Hepatitis C
Study to Determine the Potential DDIs When the Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Tablet (FDC) is Coadministered With a Cocktail of Cytochrome P450 (CYP) Probe Substrates and Transporter Probe Substrates (Digoxin and Pravastatin) in Healthy Subjects
The primary purpose of this study is to assess the effect of the Daclatasvir/Asunaprevir/BMS-791325 fixed dose combination (FDC) tablet on the pharmacokinetics of the cocktail CYP and transporter probe substrates and to assess…
- Trial name
- NCT02045966
- Testing
- Cocktail, DCV 3DAA FDC, BMS-791325
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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
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
Healthy
Drug-drug Interaction Study of Evobrutinib With Midazolam in Healthy Participants
The study will investigate the effect of single dose and multiple doses of M2951 on midazolam Pharmacokinetics (PK) in healthy participants.
- Trial name
- NCT04697511
- Testing
- Midazolam, M2951
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Metabolism, Alzheimer's Disease
Drug Interaction Study Between AZD3480 and Cytochrome P450
The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 activity.
- Trial name
- Cocktail (NCT00692510)
- Testing
- AZD3480, Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)
- Where
- Sweden
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- AstraZeneca