Clinical trials: Pharmacokinetics and Pharmacodynamics
Healthy
Interaction Between ABT-335, Rosuvastatin and Warfarin
This is a multiple-dose, double-blind, randomized, single-center, parallel-group study in adult male subjects in general good health.
- Trial name
- NCT00487136
- Testing
- Warfarin, warfarin plus ABT-335 plus rosuvastatin 5 mg, warfarin plus ABT-335 plus rosuvastatin 20 mg
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
The Safety and Tolerability of STSA-1002 Following Intravenous Infusion in Healthy Subjects
A randomized,double-blind,placebo-controlled,single-ascending dose phase Ⅰa study to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of STSA-1002 following intravenous infusion in healthy subjects
- Trial name
- NCT05032144
- Testing
- STSA-1002 injection
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Pompe Disease
First-In-Human Study to Evaluate Safety, Tolerability, and PK of Intravenous ATB200 Alone and When Co-Administered With Oral AT2221
This is an international, multi-center, open-label study designed to evaluate if the co-administration of investigational new drugs ATB200 and AT2221 is safe in adults with Pompe disease.
- Trial name
- NCT02675465
- Testing
- ATB200, AT2221
- Where
- 19 sites in United States, Australia and 4 more
- Volunteers
- 29 people
- Sponsor
- Amicus Therapeutics
Solid Tumor, Lymphoma
A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001）
This is a Phase I study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, LB1410, is safe, tolerable and efficacious in participants with advanced solid tumors or lymphoma.
- Trial name
- NCT05357651
- Testing
- LB1410
- Where
- China
- Volunteers
- 100 people
- Sponsor
- L & L Bio Co., Ltd., Ningbo, China
Healthy
A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers
The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers
- Trial name
- NCT01970072
- Testing
- Remimazolam Tosylate, Midazolam
- Where
- China
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Chronic Obstructive Pulmonary Disease (COPD)
A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects
This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential.
- Trial name
- NCT01754844
- Testing
- AZD7624
- Where
- United Kingdom
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Advanced Solid Tumor, MSI-H/dMMR Tumors
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors
- Conditions
- Advanced Solid Tumor, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma
- Trial name
- NCT04242199
- Testing
- INCB099280
- Where
- 21 sites in United States, Australia and 3 more
- Volunteers
- 182 people
- Sponsor
- Incyte Corporation
Type 2 Diabetes Mellitus
A Phase 1 Study to Investigate the Mechanism of Action of Ipragliflozin
In this study the effect of ipragliflozin on glucose homeostasis in healthy subjects and T2DM subjects, and the effect of exposure of ipragliflozin on urinary glucose excretion and plasma glucose in T2DM subjects will be…
- Trial name
- NCT01611363
- Testing
- ASP1941
- Where
- Germany
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Healthy
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin
Normal subjects will receive unfractionated heparin followed by a single dose of PER977 with dose escalation by cohort. Ten subjects enrolled in Cohort 4 will receive a single dose of PER977 followed by a one-week washout and…
- Trial name
- NCT02206087
- Testing
- PER977, Heparin Sodium
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Duchenne Muscular Dystrophy
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
RGX-202 is a gene therapy designed to deliver a transgene for a novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the C-Terminal (CT) domain.
- Trial name
- NCT05693142
- Testing
- RGX-202
- Where
- 23 sites in United States, Canada
- Volunteers
- 65 people
- Sponsor
- REGENXBIO Inc.
Healthy Volunteers
First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers
The purpose of this study is to determine the safety, tolerability and distribution and elimination of a novel therapeutic drug when administered to Healthy Volunteers.
- Trial name
- NI-0101-01 (NCT01808469)
- Testing
- Monoclonal antibody
- Where
- Netherlands
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Light Chain Bioscience - Novimmune SA
Cardiovascular
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 in Participants With Dyslipidemia
A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia.
- Trial name
- NCT06238466
- Testing
- AZD1705
- Where
- 5 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Phenylketonuria
Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU)
This study is an international, multi-center, randomized, double-blind, placebo-controlled, two-treatment, two-period cross-over study to evaluate the pharmacodynamics, safety, tolerability and pharmacokinetics of a single oral…
- Trial name
- NCT04085666
- Testing
- CDX 6114
- Where
- 2 sites in Australia, Germany
- Volunteers
- 18 people
- Sponsor
- Société des Produits Nestlé (SPN)
Lupus Nephritis, Immunoglobulin A Nephropathy
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
The goal of this clinical study is to evaluate multiple dose levels of povetacicept in adults with immunoglobulin A (IgA) nephropathy (IgAN), primary membranous nephropathy (pMN), lupus-related kidney disease (lupus nephritis …
- Conditions
- Lupus Nephritis, Immunoglobulin A Nephropathy, Membranous Nephropathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- RUBY-3 (NCT05732402)
- Testing
- Povetacicept
- Where
- 30 sites in United States, Australia and 2 more
- Volunteers
- 72 people
- Sponsor
- Alpine Immune Sciences, Inc.
Blood Pressure
An Explorative Study on the Pharmacokinetics and Pharmacodynamics of Sunitinib in Healthy Volunteers
The study is conducted: to investigate the influence of sunitinib (study drug) on the plasma biomarkers VEGF-A, VEGF-C, soluble VEGFR-2, and soluble VEGFR-3 (vessel endothelial growth factors) and on the blood pressure; to…
- Trial name
- NCT00904657
- Testing
- sunitinib (Sutent)
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Cologne
Breast Cancer, Advanced Solid Tumor
An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75202 (KAT6A/B inhibitor) alone and in combination with other therapies in…
- Trial name
- NCT07222267
- Testing
- BG-75202, CDK4 Inhibitor, Estrogen Receptor Antagonist
- Where
- 32 sites in United States, Australia and 4 more
- Volunteers
- 86 people
- Sponsor
- BeOne Medicines
NMOSD, Neuromyelitis Optica Spectrum Disorders
Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD
The primary objective of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Eculizumab in Chinese Adults with Neuromyelitis Optica Spectrum Disorders (NMOSD).
- Trial name
- ECU-NMO-304 (NCT06724809)
- Testing
- eculizumab
- Where
- 7 sites in China
- Volunteers
- 21 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Postoperative Pain
A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery
The primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test dose administration on the PK profile of a single epidural dose of DepoDur (extended-release epidural morphine) in patients undergoing…
- Trial name
- NCT00728832
- Testing
- DepoDur (extended-release epidural morphine)
- Volunteers
- 39 people
- Sponsor
- EKR Therapeutics, Inc
Healthy Volunteers
A Combined Single and Multiple Ascending Dose Study of ASP6858 in Healthy Subjects
The purpose of this study is evaluate the safety and tolerability of single and multiple ascending oral doses of ASP6858. This study will also evaluate the pharmacokinetics (PK) of ASP6858 and its metabolites as well as the…
- Trial name
- NCT02359032
- Testing
- ASP6858
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Healthy Volunteer
A Phase I Study of TS-142 in Healthy Participants (Single Doses)
The purpose of this study is to investigate the safety and pharmacokinetics of single dosing of TS-142 to healthy Japanese non-elderly participants in fasting and after meal condition.
- Trial name
- NCT04169893
- Testing
- 1 mg of TS-142, 3 mg of TS-142, 10 mg of TS-142 (fasting)
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
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