Clinical trials: Pharmacokinetic
Renal Impairment
Single-Dose PK Study of GBT440 in Subjects With Renal Impairment
A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal…
- Trial name
- NCT03161015
- Testing
- GBT440
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Global Blood Therapeutics
Pain
Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy
The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for prolonged analgesia in 12 adult subjects…
- Trial name
- NCT02199574
- Testing
- EXPAREL
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Infection, Bacterial
A First-in-Human Study With XAB05 in Healthy Subjects
This study is a randomized, placebo-controlled, first in human, single ascending dose Phase 1 study
- Trial name
- NCT05307406
- Testing
- Experimental
- Where
- Netherlands
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Xenothera SAS
Healthy
A Comparison of Various Combinations of BiDil Capsules and BiDil Tablets in Healthy Human Volunteers
This is a single center, open-label, two-period study. There will be nine healthy human volunteers arbitrarily assigned to one of four groups.
- Trial name
- NCT01587313
- Testing
- Isosorbide dinitrate / hydralazine capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Arbor Pharmaceuticals, Inc.
Peanut Allergies
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
The goal of this clinical trial is to evaluate the safety, pharmacokinetics, and effectiveness of MY006, a therapy designed to prevent severe or potentially life-threatening allergic reactions caused by accidental peanut intake.
- Trial name
- NCT07287033
- Testing
- MY006 Low Dose, MY006 Mid Dose, MY006 High Dose
- Where
- 9 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Mabylon AG
Major Depressive Disorder
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant depression (TRD) in the course of Major Depressive Disorder (MDD).
- Trial name
- NCT03965858
- Testing
- Esketamine DPI - low dose, Esketamine DPI - medium dose, Esketamine DPI - high dose
- Where
- 12 sites in Poland
- Volunteers
- 88 people
- Sponsor
- Celon Pharma SA
Alzheimer Disease
Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered
The purpose of this study is to evaluate the effects of multiple doses of verapamil 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
- NCT00745576
- Testing
- SAM-531
- Where
- France
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults
The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults
- Trial name
- NCT06360874
- Testing
- ND-003 40mg, ND-003 80mg, ND-003 160mg
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Shenzhen NewDEL Biotech, Co., Ltd
Kidney Transplantation
A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation
The purpose of the study is to assess the Pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who received a de novo kidney transplant.
- Trial name
- NCT01279538
- Testing
- bleselumab
- Where
- 21 sites in United States
- Volunteers
- 50 people
- Sponsor
- Astellas Pharma Inc
Hypertension, Dyslipidemia
A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
- Trial name
- NCT07682948
- Testing
- Investigational Product 1, Investigational Product 2, Investigational Product 1 + Investigational Product 2
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Korea United Pharm. Inc.
Amyotrophic Lateral Sclerosis
Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS)
This study is a multi-center, open-label study of intravenous (IV) ANX005 in participants with ALS.
- Trial name
- NCT04569435
- Testing
- ANX005
- Where
- 8 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Annexon, Inc.
Patients With Chemotherapy Induced Anemia (CIA)
Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia
The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 250 mg and 500 mg in patients suffering from Chemotherapy Induced anemia.
- Trial name
- PK-CIA-06 (NCT01280240)
- Testing
- Monofer(R)
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Pharmacosmos A/S
Solid Tumor
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 in Patients With Solid Tumors
Primary objective: To determine the maximum tolerated dose based on the incidence of dose limiting toxicity and the maximum administered dose of AVE8062 administered every 3 weeks in patients with advanced solid tumors.
- Trial name
- NCT00968916
- Testing
- ombrabulin (AVE8062)
- Where
- 2 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Sanofi
Chronic Kidney Disease, Secondary Hyperparathyroidism
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with…
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Vitamin D Insufficiency
- Trial name
- NCT01219855
- Testing
- Cohort 1 CTAP101 Capsules- 60µg, Cohort 1 CTAP101 Capsules - 90µg, Cohort 1 Matching Sugar Capsule
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- OPKO Health, Inc.
Epilepsy
The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin
Multiple-dose, open-label, single-period study consisting of three consecutive phases
- Trial name
- NCT02287415
- Testing
- BIA 2-093, Warfarin
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Solid Tumor, Adult, Advanced Solid Tumors
IMX-110 in Patients With Advanced Solid Tumors
Phase 1 is an open-label, multi-center dose escalation/dose expansion study designed to assess the safety, tolerability and pharmacokinetics (PK) for the recommended phase 2 dose (RP2D) of IMX-110.
- Conditions
- Solid Tumor, Adult, Advanced Solid Tumors, Pancreatic Cancer, Breast Cancer
- Trial name
- NCT03382340
- Testing
- Imx-110
- Where
- 2 sites in United States, Australia
- Volunteers
- 70 people
- Sponsor
- Immix Biopharma Australia Pty Ltd
Healthy
A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804
The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804
- Trial name
- NCT01924650
- Testing
- PH-797804
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Advanced Solid Tumors
Administration of BIIB028 to Subjects With Solid Tumors
Safety and Tolerability of BIIB028
- Trial name
- NCT00725933
- Testing
- BIIB028
- Where
- 3 sites in United States
- Volunteers
- 43 people
- Sponsor
- Biogen
Healthy Volunteers
A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects
The purpose of the study is to demonstrate demonstrate the pharmacokinetic (PK) similarity of HD201 to the European (EU) and American (US) reference products Herceptin, following a single i.v.
- Trial name
- TROIKA-1 (NCT03776240)
- Testing
- HD201, EU-Herceptin, US-Herceptin
- Where
- Australia
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Prestige Biopharma Limited
High-grade Glioma, Oligodendroglioma
Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma
This is a phase 1 open-label, multicenter study to investigate tolerability, safety and PK properties of oral OKN-007 in patients with recurrent high-grade glioma.
- Conditions
- High-grade Glioma, Oligodendroglioma, Astrocytoma, Glioblastoma Multiforme
- Trial name
- NCT05561374
- Testing
- Low-dose OKN-007, BID, Low-dose OKN-007, TID, Mid-dose OKN-007, TID
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Oblato, Inc.
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