Clinical trials: Pharmacodynamics
Pemphigus Vulgaris
Study of Efficacy and Safety of VAY736 in Patients With Pemphigus Vulgaris
The study evaluated the efficacy, safety and pharmacokinetics of VAY736 in the treatment of patients with pemphigus vulagaris (PV).
- Trial name
- NCT01930175
- Testing
- VAY736
- Where
- 5 sites in United States, Austria and 2 more
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Mild Asthma
Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of Albuterol Base/Inh) of Macleods Pharmaceuticals Ltd
This is a pharmacodynamic bioequivalence bronchoprovocation study using single-dose, double-blind, double-dummy, randomized, study consisting of four study treatments (zero dose [Placebo], E.Q.
- Trial name
- NCT06618105
- Testing
- Albuterol Sulfate 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations
- Where
- India
- Volunteers
- 144 people
- Sponsor
- Macleods Pharmaceuticals Ltd
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses
The primary objective of this trial was to investigate safety and tolerability of multiple doses of BI 409306 in healthy young and elderly volunteers.
- Trial name
- NCT01505894
- Testing
- BI 409306
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Primary Hyperoxaluria, Primary Hyperoxaluria Type 1 (PH1)
A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in infants and young children with confirmed primary hyperoxaluria type 1 (PH1).
- Trial name
- ILLUMINATE-B (NCT03905694)
- Testing
- Lumasiran
- Where
- 9 sites in United States, France and 3 more
- Volunteers
- 18 people
- Sponsor
- Alnylam Pharmaceuticals
Healthy
Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects
This study is to evaluate PK, safety, tolerability, immunogenicity, and PD profiles of SB12, EU sourced Soliris, and US sourced Soliris in healthy subjects.
- Trial name
- NCT03722329
- Testing
- Eculizumab
- Where
- Germany
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis Co., Ltd.
Advanced and Selected Solid Tumors
A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BKM120 Plus GSK1120212 in Selected Advanced Solid Tumor Patients
This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and /or recommended phase II dose (RP2D) and schedule for the PI3K (Phosphatidylinositol 3-Kinase) inhibitor BKM120 given…
- Trial name
- NCT01155453
- Testing
- BKM120, GSK1120212
- Where
- 7 sites in United States, Belgium and 3 more
- Volunteers
- 113 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Type 2
Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus
To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes mellitus (T2DM) patients.
- Trial name
- NCT00372957
- Testing
- GW823093 15mg, GW823093 30mg
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Diabetes Mellitus and Gastroparesis, Idiopathic Gastroparesis
A Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) for TAK-906 in Participants With Diabetes Mellitus and Gastroparesis (DG) or With Idiopathic Gastroparesis (IG)
The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants with Gastroparesis (GP).
- Trial name
- NCT03268941
- Testing
- TAK-906 Maleate, Metaclopramide
- Where
- 9 sites in United States
- Volunteers
- 51 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy
Drug-Drug Interaction Study to Assess the Effects of Multiple-Dose Administration of K-877 on the Pharmacodynamics and the Pharmacokinetics of Multiple-Dose Administration of Warfarin in Healthy Adult Volunteers
The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the pharmacokinetics of warfarin in healthy adults volunteers.
- Trial name
- NCT02719431
- Testing
- Warfarin, K-877
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Kowa Research Institute, Inc.
Solid Tumors, Acute Myeloid Leukemia
A Study of PLX51107 in Advanced Malignancies
The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the investigational drug PLX51107 in subjects with advanced solid tumors (including lymphoma), and advanced…
- Conditions
- Solid Tumors, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma
- Trial name
- NCT02683395
- Testing
- PLX51107
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Plexxikon
Cardiovascular Diseases, Kidney Failure, Chronic
Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis
The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.
- Trial name
- NCT01241539
- Testing
- Dabigatran etexilate
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Boehringer Ingelheim
Alpha 1-Antitrypsin Deficiency, Emphysema
Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy in adults with AATD emphysema
- Trial name
- ELEVAATE (NCT05856331)
- Testing
- SAR447537, Zemaira
- Where
- 65 sites in United States, Australia and 6 more
- Volunteers
- 99 people
- Sponsor
- Sanofi
Pemphigus Vulgaris
A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris
Open-label cohort study in adult patients with newly diagnosed or relapsing pemphigus vulgaris, with intra-patient dose-adjustment based on clinical response and BTK occupancy, and with conventional immunosuppressive "rescue…
- Trial name
- NCT02704429
- Testing
- PRN1008
- Where
- 13 sites in Australia, Croatia and 3 more
- Volunteers
- 42 people
- Sponsor
- Principia Biopharma, a Sanofi Company
Healthy
Study to Assess the Effect of Macitentan on the Electrocardiogram (ECG) in Healthy Male and Female Subjects
The study is intended to demonstrate that macitentan does not have an effect on cardiac repolarization exceeding the threshold of regulatory concern after repeated administration of daily oral doses of 10 and 30 mg to healthy…
- Trial name
- NCT02050802
- Testing
- Moxifloxacin 400 mg, Macitentan 10 mg, Macitentan 30 mg
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Actelion
Rheumatoid Arthritis
A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.
- Trial name
- NCT06883695
- Testing
- SHR-3045 Injection
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
Crohn's Disease (CD)
Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease
The aim of the study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of study drug (BCD-261) in comparison with placebo and to characterize the dose-response relationship in patients…
- Trial name
- COMANDOR (NCT07078994)
- Testing
- anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose, anti-TL1A monoclonal antibody, high dose
- Where
- 20 sites in Russia
- Volunteers
- 204 people
- Sponsor
- Biocad
Parkinson's Disease, Constipation
Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation
This is a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of an orally-administered medication to relieve symptoms of constipation associated with Parkinson's Disease.
- Trial name
- RASMET (NCT03047629)
- Testing
- ENT-01
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- Enterin Inc.
Healthy Subjects
A Phase 1 Study of CDX-0159
This is a study to determine the safety of CDX-0159 in healthy subjects.
- Trial name
- NCT04146129
- Testing
- CDX-0159, Normal saline
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Celldex Therapeutics
Overweight and Obesity
A Phase I Study of GZR18 Injection in Obese/Overweight Subjects
This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and…
- Trial name
- NCT06548945
- Testing
- GZR18
- Where
- China
- Volunteers
- 16 people
- Sponsor
- Gan and Lee Pharmaceuticals, USA
Type 1 Diabetes, Hypoglycemia
Effect of ZT-01 on Glucagon During Hypoglycemia in Type 1 Diabetes Mellitus
The purpose of this study is to determine whether ZT-01 increases the glucagon response to hypoglycemia in type 1 diabetes (T1D).
- Trial name
- NCT05007977
- Testing
- ZT-01 low dose, ZT-01 high dose
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Zucara Therapeutics Inc.
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