Clinical trials: Metabolites
Locally Advanced or Metastatic Solid Tumors
Oral Bioavailability and Mass Balance Trial With Pimasertib
This is a Phase 1, open-label, single centered trial to evaluate the mass balance, bioavailability and metabolism of pimasertib in cancer subjects with locally advanced or metastatic solid tumors.
- Trial name
- NCT01713036
- Testing
- Pimasertib
- Where
- Hungary
- Volunteers
- 6 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Contraception, Menopause
Study Conducted to Further Understand the Elimination Pathways, Metabolite Profile and PK Profile of 14C-estetrol
This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).
- Trial name
- NCT02720224
- Testing
- Estetrol
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Estetra
Healthy
Pharmacotoxicology of Trichloroethylene Metabolites
This is a research study to look at how Dichloroacetate (DCA), and investigational drug and chloral hydrate are broken down in the body.
- Trial name
- NCT01128270
- Testing
- Dichloroacetate environmental dose, Chloral Hydrate environmental dose, Dichloroacetate therapeutic dose
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of Florida
Epilepsy
Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites
The purpose of this study is to determine the effects of age on the pharmacokinetic profile of BIA 2-093 and its active metabolites.
- Trial name
- NCT02172755
- Testing
- BIA 2-093
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy Volunteers
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects
This single-center, open-label, non randomized Phase I study is being conducted to investigate the pharmacokinetics, mass balance and metabolite profiling and identification after a single oral dose of 100mg of [14C]-MD1003 in 6…
- Trial name
- NCT04223232
- Testing
- [14C]-MD1003
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- MedDay Pharmaceuticals SA
Drug-Drug Interaction, Healthy Volunteers
The Effects of Multiple Dose Fluoxetine and Metabolites on CYP1A2, CYP2C19, CYP2D6 and CYP3A4 Activity
Inhibitory drug-drug interactions (DDIs) are a considerable concern as inhibition of drug's clearance can lead to increased plasma concentrations and subsequent adverse events and toxicities.
- Trial name
- FLUOXETINE (NCT01361217)
- Testing
- Fluoxetine, Lovastatin, Omeprazole, caffeine, midazolam, dextromethorphan
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Washington
Healthy Volunteers
A Study of LY2835219 in Healthy Participants
The aim of this two-period study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and when it is given as a single oral dose in combination with rifampin (a Food and Drug…
- Trial name
- NCT02256267
- Testing
- LY2835219, Rifampin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Melanoma and Brain Metastases
Dabrafenib/Trametinib, BRAF or BRAF AND MEK Pre-op With BRAF and MEK Post-op, Phase IIB, Melanoma With Brain Mets,Biomarkers and Metabolites
This is a global, multi-centre, open-label, study of GSK2118436 conducted in up to 30 evaluable subjects with resectable, BRAF V600E or V600K mutation-positive metastatic melanoma to the brain.
- Trial name
- NCT01978236
- Testing
- Dabrafenib 150 mg, Trametinib 2.0 mg
- Where
- 3 sites in United States, Australia
- Volunteers
- 6 people
- Sponsor
- GlaxoSmithKline
Healthy Adults
Effect of Bismuth Subsalicylate on the Gut Microbiome and Host Response in Healthy Adults
Background: Many kinds of good or normal bacteria live on your skin and inside your stomach and intestines (gut). These bacteria are important to your health.
- Trial name
- NCT05930197
- Testing
- Bismuth subsalicylate
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Obesity, Cardiovascular Diseases
Oatmeal Effect on N-acyl-phosphatidylethanolamines
N-acyl-phosphatidylethanolamine (NAPEs) and their active metabolites, N-acyl-ethanolamides (NAEs) are lipid satiety factors that are normally biosynthesized in the intestinal tract in response to food intake.
- Trial name
- NAPE (NCT03468179)
- Testing
- Oatmeal
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Healthy
Tepotinib Drug-Drug Interaction Study With Carbamazepine in Healthy Participants
The purpose of this study was to assess the effect of multiple doses of carbamazepine on single- dose tepotinib pharmacokinetics in healthy participants.
- Trial name
- NCT05213481
- Testing
- Tepotinib, Carbamazepine
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Congenital Lactic Acidosis
Pharmacotoxicology of Trichloroethylene Metabolites
To establish the relationship between human MAAI haplotype and DCA and tyrosine metabolism. This aim test the postulates that MAAI haplotype determines, and thus can predict,1) dose-dependent DCA kinetics and biotransformation.
- Trial name
- NCT00874276
- Testing
- Dichloroacetate (DCA), Genetic Marker on Chromosome 14q24.3
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Florida
Contraception
Assessment of the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and Comparison of the Folate Metabolites During the 24 Weeks of Treatment (Yasmin + Metafolin Versus Yasmin + Folic Acid) Followed by a 20 Week Elimination Phase of Folate
The purpose of this study is to examine and compare the uptake of levomefolate calcium (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of treatment with a following folate elimination phase…
- Trial name
- NCT01258660
- Testing
- EE 0.03 mg/DRSP 3 mg (Yasmin) + folic acid
- Where
- Germany
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Bayer
Chronic Myeloid Leukemia, Chronic Phase
Omega -3 Fatty Acid in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia
This is a Phase I/II single site, open label clinical trial. The purpose of the Phase I portion is to determine the safety, tolerability, and recommended Phase II dose of Eicosapentaenoic Acid (EPA) when given daily in…
- Trial name
- NCT04006847
- Testing
- Eicosapentaenoic Acid, Tyrosine kinase inhibitor
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Milton S. Hershey Medical Center
Healthy
Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole
The purpose of this study is to assess the pharmacokinetics of buprenorphine and its metabolites in the presence and absence of ketoconazole.
- Trial name
- NCT01259115
- Testing
- Buprenorphine transdermal patch, Ketoconazole tablet
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Hepatic Impairment, Hepatic Insufficiency
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.
- Conditions
- Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT03968848
- Testing
- acalabrutinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Multiple Myeloma
A Study of PAD Followed by Autologous Stem Cell Transplantation (ASCT) to Treat Newly Diagnosed Multiple Myeloma
This is a multicentre; single arm study in subjects with newly diagnosed multiple myeloma. The primary objectives of this study is to assess the effect of bortezomib combination therapy (PAD regimen) followed by ASCT on bone…
- Trial name
- NCT01852799
- Testing
- PAD Followed by ASCT
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Shanghai Changzheng Hospital
Healthy Lactating Women
Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women
This is an open label, single treatment, multiple doses lactation study of SPN-812 in healthy lactating women. The study is designed to assess the excretion of viloxazine and its major metabolite 5-HVLX-gluc into breast milk…
- Trial name
- SPN-812 (NCT06259331)
- Testing
- SPN-812 (600mg, QD)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Supernus Pharmaceuticals, Inc.
NASH With Fibrosis
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431).
- Trial name
- NCT05737433
- Testing
- [14C]-rencofilstat 225mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
Parkinson Disease
Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young Subjects
The purpose of this study is to determine the effects of age on the pharmacokinetic (PK) profile of BIA 9-1067 and its metabolites.
- Trial name
- NCT02092168
- Testing
- BIA 9-1067
- Where
- France
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.