Clinical trials: Pharmacodynamics
Diabetes, Diabetes Mellitus, Type 1
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the trial drug in the body) properties of…
- Trial name
- NCT01773798
- Testing
- insulin degludec/insulin aspart 15, insulin degludec/insulin aspart, insulin degludec
- Where
- Austria
- Volunteers
- 33 people
- Sponsor
- Novo Nordisk A/S
Advanced Malignant Glioma, Anaplastic Astrocytomas
AMG 595 First-in-Human in Recurrent Gliomas
This is an open-label, sequential dose exploration study of single agent AMG 595 administered in subjects with recurrent glioblastoma multiforme (GBM) and/or anaplastic astrocytomas (AA).
- Conditions
- Advanced Malignant Glioma, Anaplastic Astrocytomas, Glioblastoma Multiforme
- Trial name
- NCT01475006
- Testing
- AMG 595
- Where
- 4 sites in United States, Australia
- Volunteers
- 32 people
- Sponsor
- Amgen
Hypoglycemia
Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia
The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.
- Trial name
- NCT01972152
- Testing
- G-Pen(TM) 1 mg, Lilly Glucagon(TM) 1 mg, G-Pen(TM) 0.5 mg
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Xeris Pharmaceuticals
Healthy
A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers
The purpose of this study is to assess the use of 2 different Prothrombin Complex Concentrates (PCCs) on their ability to reverse (normalize) the pharmacodynamic effects of rivaroxaban in healthy adult volunteers.
- Trial name
- NCT01656330
- Testing
- Rivaroxaban 20 mg twice daily, Rivaroxaban 20 mg once daily, Profilnine SD
- Where
- Belgium
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
End Stage Renal Disease Requiring Hemodialysis
Factor XI LICA to Reduce Events Such as Heart Attack and Stroke in Patients Whose Kidneys Are no Longer Able to Work as They Should and Require Treatment to Filter Wastes From the Blood: Focus is on the Safety of BAY2976217 and the Way the Body Absorbs, Distributes and Removes the Study Drug
Patients whose kidneys are no longer able to work as they should and require treatment to filter wastes from the blood (hemodialysis) are at high risk for blood clots that form in blood vessels (thrombosis) blocking blood flow…
- Trial name
- RE-THINc ESRD (NCT04534114)
- Testing
- Fesomersen sodium (BAY2976217)
- Where
- 69 sites in United States, Belgium and 13 more
- Volunteers
- 307 people
- Sponsor
- Bayer
Chronic Obstructive Pulmonary Disease
Safety, Tolerability, and Pharmacodynamic Effect Study of PUR118
The purpose of this study is to establish single and multiple dose safety in healthy subjects and subjects with mild chronic pulmonary obstructive disease (COPD).
- Trial name
- NCT01333904
- Testing
- PUR118
- Where
- United Kingdom
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Pulmatrix Inc.
GERD
Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects
This is a Phase I, single-center, open label parallel-group, randomized study designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD, by continuous intragastric pH measurment), safety and tolerability of single and…
- Trial name
- NCT05742984
- Testing
- linaprazan glurate 25 mg QD, linaprazan glurate 50 mg QD, linaprazan glurate 75 mg QD
- Where
- Slovenia
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) who have the patatin-like phospholipase…
- Trial name
- NCT05395481
- Testing
- LY3849891
- Where
- 16 sites in United States, Japan and 1 more
- Volunteers
- 115 people
- Sponsor
- Eli Lilly and Company
Fabry Disease
Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study
Study to evaluate the long-term safety, tolerability, and pharmacodynamics (PD) of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease
- Trial name
- NCT00526071
- Testing
- migalastat HCl
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 23 people
- Sponsor
- Amicus Therapeutics
Pharmacokinetics, Pharmacodynamics
Study to Evaluate Pharmacokinetic and Pharmacodynamic Drug Interactions and Safety of IY-NS250 and IY-NT-SR
This study comparative evaluation of safety and pharmacokinetic and pharmacodynamic properties in oral repeat administration of IY-NS250 and IY-NT-SR in healthy adult
- Trial name
- NCT06725992
- Testing
- IY-NS250, IY-NT-SR
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Il-Yang Pharm. Co., Ltd.
Transplant-Associated Thrombotic Microangiopathy
A Study of Pegcetacoplan for Patients With Transplant-associated Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplantation
The purpose of the study was to assess pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and safety of pegcetacoplan in patients with TA-TMA after HSCT.
- Trial name
- NCT05148299
- Testing
- Pegcetacoplan
- Where
- 14 sites in United States, France and 3 more
- Volunteers
- 12 people
- Sponsor
- Swedish Orphan Biovitrum
Pharmacokinetics, Pharmacodynamics
A Phase I Study in Young Healthy Women to Investigate the Effects of Laquinimod on Standard Oral Contraceptive When Both Treatments Are Given Together
This is a single center, randomized, double blind, placebo controlled, 2-way crossover drug-drug interaction (DDI) study to assess the effect of laquinimod on the PK and PD of ethinylestradiol (EE) and levonorgestrel (LNG) a…
- Trial name
- NCT02085863
- Testing
- laquinimod
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Chronic Hepatitis C
Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin
This study is being conducted to see if the investigational medication, valopicitabine, is safe to use in combination with ribavirin, a drug approved by the FDA for treating hepatitis C infection.
- Trial name
- NCT00395421
- Testing
- NM283 plus Peg-IFNα-2a
- Where
- 2 sites in United States
- Volunteers
- 114 people
- Sponsor
- Merck Sharp & Dohme LLC
Type 2 Diabetes Mellitus
A Study to Evaluate AZP531 in Healthy Volunteers, Overweight/Obese Volunteers and Patients With Type 2 Diabetes Mellitus
Objectives: Primary Objectives To investigate the safety and tolerability of single ascending doses of AZP- 531 in healthy volunteers.
- Trial name
- NCT02040012
- Testing
- AZP-531
- Where
- United Kingdom
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Alizé Pharma
Diabetes Mellitus, Type 2
4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes
Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773
- Trial name
- NCT00558571
- Testing
- BI 10773 low dose, BI 10773 medium dose, BI 10773 high dose
- Where
- 3 sites in Germany
- Volunteers
- 78 people
- Sponsor
- Boehringer Ingelheim
Advanced Solid Tumor
A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Receptor 2b (FGFR2b) Antibody Drug Conjugate, in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with…
- Trial name
- NCT06625593
- Testing
- BG-C137, Anticancer Agents
- Where
- 52 sites in United States, Australia and 2 more
- Volunteers
- 168 people
- Sponsor
- BeOne Medicines
Healthy Volunteer
A Phase I Study of TS-142 in Healthy Participants (Repeated Doses)
The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly participants.
- Trial name
- NCT04169906
- Testing
- TS-142, 10 mg, TS-142, 20 mg, TS-142, 30 mg
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Taisho Pharmaceutical 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
X-linked Hypophosphatemia (XLH)
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in pediatric Chinese patients with XLH
- Trial name
- NCT04842032
- Testing
- KRN23
- Where
- 5 sites in China
- Volunteers
- 28 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Safety
First in Human Single Ascending Dose Study of MOR107
This is the first in human study of MOR107. It is a 2 part, single centre, double-blind, randomised, placebo-controlled study in healthy male subjects.
- Trial name
- NCT03067363
- Testing
- MOR107, Low sodium diet
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Alan Richardson
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