Clinical trials: Metabolite
Healthy
Pharmacokinetics of Simvastatin and Its Metabolite Simvastatin Acid With and Without Concomitant Administration of Telmisartan in Healthy Subjects
To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant administration of telmisartan
- Trial name
- NCT02187536
- Testing
- Telmisartan, Simvastatin
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Health Volunteers
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
This study looks at how the body handles an investigational drug called OD-001. Researchers want to learn how the medicine is absorbed, how it is broken down, and how it leaves the body.
- Trial name
- NCT07900607
- Testing
- [14C]OD-001
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Odyssey Therapeutics, Inc.
Healthy Volunteers
A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants
This study will evaluate the effect of fluconazole and isavuconazole on the PK of acalabrutinib and its active metabolite, ACP-5862.
- Trial name
- NCT05140096
- Testing
- Acalabrutinib, Fluconazole, Isavuconazole
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
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.
Hepatitis B
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg…
- Trial name
- NCT01427868
- Testing
- LB80380 maleate salt, LB80380 free base
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Cancer
A Pharmacokinetics (PK) and Safety Study to Determine the Effect of Repeat Dosing of Trametinib on Combined Oral Contraceptive (Norethindrone Plus Ethinyl Estradiol) in Female Subjects With Solid Tumors
This is a Phase I, open-label, non-randomized, sequential, two-period, repeat-dose study to evaluate the effect of trametinib 2 milligram (mg) once daily on the repeat-dose pharmacokinetic (PK) of an oral contraceptive (OC)…
- Trial name
- NCT02292732
- Testing
- Trametinib 0.5 mg, Trametinib 2 mg, ORTHO-NOVUM® tablet 1/35
- Sponsor
- GlaxoSmithKline
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
Post-operative Nausea and Vomiting
Mass-balance Study of [14C]-APD421 in Healthy Volunteers
Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass balance recovery, metabolite profile, metabolite identification and pharmacokinetics of 14C-labelled APD421
- Trial name
- NCT02881840
- Testing
- 14C-APD421
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
Healthy
An Open-label, Single-dose, Non-randomized Study of IV 14C-labeled PER977 in Healthy Male Subjects
This is an open-label, single-dose, non-randomized study in healthy male subjects to characterize the mass balance, metabolic disposition, and identification of the metabolites and general metabolic pathways following…
- Trial name
- NCT02205905
- Testing
- 14C PER977
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Healthy Participants
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants
This study is being conducted to assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants.
- Trial name
- NCT06309394
- Testing
- INCB099280
- Where
- United Kingdom
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Hepatic Impairment
Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment
Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules
- Trial name
- NCT02242734
- Testing
- 20 mg HC-ER
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zogenix, Inc.
Healthy Male Volunteer
The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea
To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.
- Trial name
- CKD-501 DDI (NCT01133431)
- Testing
- CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Breast Cancer
A Study to Assess the Mass Balance of [14C]HRS-8080 in Healthy Chinese Postmenopausal Female Subjects.
This single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body.
- Trial name
- NCT07320521
- Testing
- [14C]HRS-8080
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Healthy, Volunteer
To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants
The purpose of this study is to determine the effect of carbamazepine on the blood levels of mirdametinib and how long it takes the body to eliminate mirdametinib when both drugs are administered orally in healthy participants.
- Trial name
- NCT07279233
- Testing
- Mirdametinib, Mirdametinib and Carbamazepine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Healthy
Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] LC15-0444
This was an open-label, non-randomised, single-dose study in 6 healthy male subjects. Subjects attended a screening visit within 28 days before drug administration.
- Trial name
- NCT01603238
- Testing
- [14C]-LC15-0444
- Where
- South Korea
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Autoimmune Diseases, Fibrosis
Human Absorption, Distribution and Metabolism Study (hAME) [14C]-KD025
Human, absorption, metabolism and excretion study of belumosudil (KD025)
- Trial name
- KD025-108 (NCT03907540)
- Testing
- Belumosudil 200 mg tablet, [14C]-KD025 at a dose of 100 μg in a 5 mL solution IV microdose, [14C]-KD025 200 mg capsule
- Where
- United Kingdom
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Kadmon Corporation, LLC
Healthy
A Metabolite Identification, Mass Balance, and PK Study of [14C]-Asimadoline to Healthy Adult Male Volunteers
This is an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers.
- Trial name
- NCT01380561
- Testing
- asimadoline
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Tioga Pharmaceuticals
Healthy Volunteers
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects
To assess the mass balance recovery after a single oral dose of 14C-AB1010
- Trial name
- NCT05200169
- Testing
- 14C-AB1010
- Where
- United Kingdom
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- AB Science
Atherosclerosis
A Healthy Volunteer Pharmacokinetic Study of Single and Repeat Doses of SB-480848
This study is designed to assess the pharmacokinetics of darapladib and its metabolites following single and 28 days of repeat dosing of darapladib.
- Trial name
- NCT00743860
- Testing
- darapladib
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Mass Balance Recovery, Metabolite Profile, and Metabolite Identification of [14C]-Paxalisib in Healthy Male Subjects
Single-centre, open-label, non-randomised study to assess the mass balance recovery, PK, metabolite profile, and metabolite identification of a single oral dose of 14C labelled paxalisib ([14C] Paxalisib) in healthy male subjects.
- Trial name
- NCT05012670
- Testing
- [14C]-Paxalisib Capsule
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Kazia Therapeutics Limited