Clinical trials: Pharmacodynamics
Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD) study of subcutaneous (SC) Pegfilgrastim injection (6…
- Trial name
- NCT04014062
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Lymphomas, Solid Tumors
TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas
Background: Methoxyamine hydrochloride (TRC102) is a new cancer treatment drug that may help improve the results of chemotherapy.
- Conditions
- Lymphomas, Solid Tumors, NSCLC, Metastatic Colon Carcinoma
- Trial name
- NCT01851369
- Testing
- TRC102, CT scan, Lomotil
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- National Cancer Institute (NCI)
Central Nervous System Effects of Diphenhydramine, Pharmacokinetics of Diphenhydramine
Central Nervous System Effects Following Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling
This study seeks to explore the magnitude and duration of central nervous system effects and pharmacokinetics after intravenous infusion of diphenhydramine.
- Trial name
- NCT05219604
- Testing
- DiphenhydrAMINE Injectable Solution
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Dent Neuroscience Research Center
Pulmonary Disease, Chronic Obstructive
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Dose-Response Relationship of Multiple Doses of GSK2269557 Administered as a Dry Powder to Chronic Obstructive Pulmonary Disease (COPD) Patients
This is a randomised, double-blind, placebo controlled, parallel group study to evaluate the safety, tolerability, pharmacokinetics and dose response of multiple doses of GSK2269557 administered as a dry powder in COPD subjects.
- Trial name
- NCT02130635
- Testing
- GSK2269557 100 MCG, GSK2269557 500 MCG
- Where
- 2 sites in Germany
- Volunteers
- 64 people
- Sponsor
- GlaxoSmithKline
Healthy Subjects
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Healthy Volunteers
- Trial name
- NCT04027803
- Testing
- BCD-148, Soliris
- Where
- Russia
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Biocad
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
A Study of Single or Repeated Doses of Glucagon in Participants With Diabetes
This study will investigate how the body processes nasal glucagon (NG) and the effect of nasal glucagon on the body. The study is expected to last about 50 days for each participant.
- Trial name
- NCT02806973
- Testing
- Nasal Glucagon
- Where
- Canada
- Volunteers
- 32 people
- Sponsor
- Eli Lilly and Company
Acute Coronary Syndrome (ACS), High On-treatment Platelet Reactivity (HTPR)
The Effect of IV Cangrelor and Oral Ticagrelor Study
Major heart attacks are caused by a number of factors, the two major of which are furring up of a coronary artery with atheroma and then sudden clot formation on this area leading to a blockage and interruption of blood flow.
- Conditions
- Acute Coronary Syndrome (ACS), High On-treatment Platelet Reactivity (HTPR), Microvascular Obstruction (MVO), ST-segment Elevation Myocardial Infarction (STEMI)
- Trial name
- NCT02733341
- Testing
- Cangrelor, Ticagrelor
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- The Royal Wolverhampton Hospitals NHS Trust
Elevated LDL Cholesterol
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of…
- Trial name
- NCT01004705
- Testing
- Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),, Simvastatin
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Ferrer Internacional S.A.
Coronary Artery Bypass Graft, Cardiopulmonary Bypass
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery
The purpose of this study is to demonstrate that periprocedural infusion of escalating doses of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to characterize the single dose pharmacokinetics of…
- Trial name
- NCT01535222
- Testing
- MDCO-2010
- Volunteers
- 32 people
- Sponsor
- The Medicines Company
Breast Neoplasms
Study Evaluating HKI-272 in Tumors
The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose (MTD) for HKI-272.
- Trial name
- NCT00146172
- Testing
- neratinib
- Where
- 5 sites in United States
- Volunteers
- 73 people
- Sponsor
- Puma Biotechnology, Inc.
Type 2 Diabetic Nephropathy
A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-03882845…
- Trial name
- NCT01488877
- Testing
- PF-03882845, Spironolactone
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Pfizer
Non Small Cell Lung Cancer
Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer
This study was conducted to evaluate the preliminary effectiveness and safety of treatment with tislelizumab alone and in combination with other investigational agents prior to surgery (neoadjuvant treatment) in adults with…
- Trial name
- NCT05577702
- Testing
- Tislelizumab, Ociperlimab, Alcestobart
- Where
- 14 sites in China
- Volunteers
- 121 people
- Sponsor
- BeiGene
Acute Kidney Injury Due to Sepsis
Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a…
- Trial name
- NCT05507437
- Testing
- TIN816 70 mg lyophilisate powder
- Where
- 7 sites in Belgium, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Obesity
Phase 2a Placebo-Controlled Study of VTX3232 Alone or in Combination With Semaglutide in Obesity
This study evaluated the safety of VTX3232 administered alone or in combination with semaglutide in participants with obesity. Approximately 160 participants were randomized to receive VTX3232 30 mg, placebo, VTX3232 30 mg in…
- Trial name
- NCT06771115
- Testing
- VTX3232 30 mg, VTX3232 30 mg in combination with semaglutide
- Where
- 14 sites in United States
- Volunteers
- 175 people
- Sponsor
- Zomagen Biosciences Ltd.
Cancer
BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)
This was a four part, phase I/II study aimed to evaluate the safety, tolerability and efficacy of combination of an anti-EGFR antibody panitumumab (P) either with a BRAF inhibitor (dabrafenib (D); GSK2118436) alone or with the…
- Trial name
- NCT01750918
- Testing
- Dabrafenib, Trametinib, Panitumumab
- Where
- 20 sites in United States, Belgium and 6 more
- Volunteers
- 166 people
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment, Liver Diseases
PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with mild, moderate, and severe hepatic impairment (defined…
- Conditions
- Hepatic Impairment, Liver Diseases, Digestive System Diseases
- Trial name
- NCT02121860
- Testing
- IDN-6556
- Where
- 3 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Conatus Pharmaceuticals Inc.
Non Small Cell Lung Cancer
A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer
Lung cancer tumors become resistant to the first generation epidermal growth factor receptor (EGFR) inhibitors erlotinib or gefitinib by changing and increasing the activity of two cell signaling pathways: the cMET pathway and…
- Trial name
- NCT01121575
- Testing
- PF-02341066, PF-00299804
- Where
- 10 sites in United States, Australia
- Volunteers
- 70 people
- Sponsor
- Pfizer
Plaque Psoriasis
Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis
The purpose of this study is to establish proof of efficacy for namilumab in moderate to severe plaque psoriasis, measured as Psoriasis Area and Severity Index (PASI)75 response rate at Week 12.
- Trial name
- NCT02129777
- Testing
- Namilumab
- Where
- 10 sites in Canada
- Volunteers
- 122 people
- Sponsor
- Takeda
Type 2 Diabetes Mellitus
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
The purposes of this study are to determine: The safety of tirzepatide and any side effects that might be associated with it. How much tirzepatide gets into the bloodstream and how long it takes the body to remove it.
- Trial name
- NCT03322631
- Testing
- Tirzepatide
- Where
- 2 sites in Japan
- Volunteers
- 48 people
- Sponsor
- Eli Lilly and Company
Pharmacokinetics
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064 (MK-1064-001)
The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the safety, pharmacokinetics and pharmacodynamics of rising, single oral doses MK-1064 in healthy, young, male participants.
- Trial name
- NCT02549014
- Testing
- MK-1064
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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