Clinical trials: Drug Kinetics
LGMD2I
A Trial of PF-06252616 in Ambulatory Participants With LGMD2I
The investigational product PF 06252616, a humanized anti myostatin monoclonal antibody that neutralizes myostatin (GDF8) is in development for the treatment of Limb Girdle Muscular Dystrophy 2I (LGMD2I) to preserve and/or…
- Trial name
- NCT02841267
- Testing
- PF 06252616
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Kathryn Wagner
Fabry Disease
A Study in Patients With Fabry Disease Who Are on Chronic Hemodialysis Therapy for Treatment of End-stage Renal Insufficiency.
People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme.
- Trial name
- NCT00312767
- Testing
- Fabrazyme (agalsidase beta)
- Where
- United States
- Sponsor
- Genzyme, a Sanofi Company
Locally Advanced or Metastatic Malignant Solid Tumors
A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors
Specific proteins found in tumors help the tumors spread and grow. People with solid tumors often have a protein called TROP2 in their tumor.
- Trial name
- NCT07287995
- Testing
- ASP2998, Pembrolizumab, Enfortumab Vedotin
- Where
- 9 sites in United States, Japan
- Volunteers
- 428 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Postoperative Nausea
How Pregnant Women and Their Babies Metabolize Ondansetron Compared to a Group of Non-pregnant Women
This is called "Aim 1" of the investigators' NIH grant. Ondansetron (Zofran) is a safe and effective drug used in pregnant women to prevent nausea but the investigators do not know what effect pregnancy may have on the metabolism…
- Trial name
- Zofran_PK (NCT01801475)
- Testing
- Ondansetron
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Stanford University
Hepatic Impairment and Healthy Female
Pharmacokinetics of VC005 Tablets in Subjects With Hepatic Impairment and Normal Hepatic Function
This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with mild and moderate hepatic impairment compared to…
- Trial name
- NCT07551557
- Testing
- VC005 Tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
Schizophrenia, Major Depressive Disorder (MDD)
A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive…
- Conditions
- Schizophrenia, Major Depressive Disorder (MDD), Bipolar Disorder
- Trial name
- NCT07549581
- Testing
- SEP-380135
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy Volunteers
Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045
Phase I, single-center, randomized, double-blind, placebo-controlled, multiple ascending dose (MAD), study to evaluate the safety/tolerability and pharmacokinetics (PK) of FP-045 administered to normal health volunteers (NHVs).
- Trial name
- NCT03686930
- Testing
- Cohort 1 - FP-045 oral solution, Cohort 2 - FP-045 oral solution, Cohort 3 - FP-045 oral solution
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Foresee Pharmaceuticals Co., Ltd.
Acromegaly
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma.
- Trial name
- NCT00171730
- Testing
- Pasireotide
- Where
- 10 sites in United States, Australia and 5 more
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteers
Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects
This is a Phase 1 single center, parallel group study to assess and compare the safety, tolerability, PK and PD of 4 single ascending doses of P1101 (100, 200, 300, and 450 μg) following subcutaneous administration in healthy…
- Trial name
- NCT03546465
- Testing
- ropeginterferon alfa-2b
- Where
- Australia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- PharmaEssentia Japan K.K.
Paroxysmal Nocturnal Hemoglobinuria, PNH
To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants.
Phase I Study Evaluating Safety, Tolerability, PK and PD of Single and Multiple Doses of TUL321 Capsule in Healthy Participants and Food Effect on PK
- Trial name
- NCT07760467
- Testing
- Part1: TUL321, Part2: TUL321
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Zhuhai United Laboratories Co., Ltd.
Alcohol Drinking, Depression
Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism
The two purposes of this study are 1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has 1.
- Conditions
- Alcohol Drinking, Depression, Smoking Cessation, Attention Deficit Disorder
- Trial name
- NCT00330434
- Testing
- Trial Withdrawn 1, Trial Withdrawn 2
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Tufts University
-Unhealthy Children With a History of Prematurity
A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis)
A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B.
- Trial name
- NCT00240929
- Testing
- MEDI-493
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- MedImmune LLC
Epilepsy
The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin
The study is to evaluate safety, efficacy and pharmacokinetics of intravenously administered fosphenytoin in patients with neurosurgery, head trauma, epilepsy or status epilepticus who are requiring a loading dose of phenytoin.
- Trial name
- NCT00908453
- Testing
- fosphenytoin
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Nobelpharma
Schizophrenia
Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic/Efficacy
Evaluate the safety and tolerability of multiple subcutaneous injections of various dosages of risperidone with clinically stable schizophrenia
- Trial name
- NCT01677377
- Testing
- Risperidone, RBP-7000
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- Indivior Inc.
Smoking
Comparison of Nicotine Plasma Concentrations and Subjective Effects for Three Menthol Electronic Cigarettes vs Combustible Menthol Cigarettes and Nicotine Gum
The purpose of this study is to measure plasma nicotine uptake parameters, physiological measures, and subjective effect measures in smokers during and following a single ad libitum use of three menthol electronic cigarettes…
- Trial name
- NCT02664012
- Testing
- Own Brand Menthol Cigarette, Electronic Menthol Cigarette #1, Electronic Menthol Cigarette #2
- Where
- United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- R.J. Reynolds Vapor Company
Advanced/Metastatic Solid Tumors
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid Tumor
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic profiles, and preliminary efficacy of HLX97 ( KAT6A/B inhibitor) in patients with advanced/metastatic solid…
- Trial name
- NCT07480681
- Testing
- HLX97, Fulvestrant
- Volunteers
- 138 people
- Sponsor
- Shanghai Henlius Biotech
Healthy, Pharmacokinetics of ASP1941
A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Pioglitazone Hydrochloride When Given Together to Healthy Subjects
The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics and safety following the administration of ASP1941 and pioglitazone hydrochloride in multiple and single doses.
- Trial name
- NCT01088919
- Testing
- ASP1941, pioglitazone hydrochloride
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Multiple Sclerosis
Comparison Study of PF530 and Betaferon in Healthy Subjects
The purpose of this study is to compare the safety, tolerability, and blood levels of two interferon beta-1b products, Betaferon and PF530, in healthy volunteers.
- Trial name
- NCT02474134
- Testing
- Interferon beta-1b (PF530, Betaferon)
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfenex, Inc
Malignant Tumors of Adults
A Clinical Study of SHR-4506 Injection in Patients With Malignant Tumors
The study is being conducted to evaluate the safety and tolerability of SHR-4506 Injection in patients with malignant tumors and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).
- Trial name
- NCT07068932
- Testing
- SHR-4506 Injection
- Where
- 2 sites in China
- Volunteers
- 102 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Healthy
Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics(PK) of PF-06865571
The current study is the first clinical trial proposed with PF-06865571. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single doses of PF-06865571 to healthy adult…
- Trial name
- NCT03092232
- Testing
- PF-06865571
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Pfizer