Clinical trials: Pharmacodynamics
Pompe Disease (Late-onset)
ZIP Study-OL Study of Safety, PK, Efficacy, PD, Immunogenicity of ATB200/AT2221 in Pediatrics Aged 0 to < 18 y.o. w/LOPD
This is a Phase 3, open-label, multicenter study to evaluate the safety, PK, efficacy, PD, and immunogenicity of Cipaglucosidase Alfa/Miglustat treatment in enzyme replacement therapy (ERT)-experienced and ERT-naïve pediatric…
- Trial name
- NCT03911505
- Testing
- Cipaglucosidase Alfa, Miglustat
- Where
- 17 sites in United States, Australia and 4 more
- Volunteers
- 21 people
- Sponsor
- Amicus Therapeutics
Chronic Pruritus of Unknown Origin
Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO)
The primary objective of this study is to assess the PK/PD relationship of nemolizumab in adult participants aged 18 years or above with chronic pruritus of unknown origin (CPUO) during a 16-week treatment period.
- Trial name
- CPUO (NCT07074977)
- Testing
- nemolizumab
- Where
- 26 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Galderma R&D
Obesity
ERX1000 - Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Male and Female Subjects With Obesity
The primary objective is to assess the safety and tolerability of single and multiple oral doses of ERX1000 in obese subjects.
- Trial name
- NCT04890873
- Testing
- ERX1000
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- ERX Pharmaceuticals
Healthy Volunteer
First-in-human Study of HSK56630 in Healthy Subjects
This is a first-in-human, single ascending dose (SAD) study in healthy adult participants. This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK56630…
- Trial name
- NCT07580794
- Testing
- HSK56630
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healthy Volunteer
A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers
This randomized, observer-blinded, placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers.
- Trial name
- NCT01620931
- Testing
- RO5469754
- Where
- Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Asthma
A Trial of SHR-1905 in Healthy Subjects and Subjects With Mild Asthma
This study is a phase 1 single dose escalation study of SHR-1905 in healthy subjects and subjects with mild asthma. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1905 in healthy…
- Trial name
- NCT04905602
- Where
- China
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Postsurgical Pain Management
A Study on TLC590 for Managing Postsurgical Pain
This Phase 2 open-label trial investigates the pharmacokinetics (PK), pharmacodynamics, and safety profile of TLC590 across various surgical procedures.
- Trial name
- NCT06574269
- Testing
- TLC590, Ropivacaine
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- TLC Biopharmaceuticals, Inc.
Myelofibrosis, Primary Myelofibrosis (PMF)
Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis
This study will be an open-label phase 1/2a study to evaluate the safety and tolerability of PXS-5505 in patients with primary, postpolycythemia vera (PV) or post-essential thrombocythemia (ET) myelofibrosis.
- Conditions
- Myelofibrosis, Primary Myelofibrosis (PMF), Post- Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
- Trial name
- NCT04676529
- Testing
- PXS-5505
- Where
- 23 sites in United States, Australia and 2 more
- Volunteers
- 43 people
- Sponsor
- Syntara
Healthy
PK and PD Study After Single Dose, Intravenous Administration of Two Epoetin Alfa, Eritromax and Eprex, in Healthy Subjects
The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects following administration of single intravenous…
- Trial name
- NCT01664195
- Testing
- Epoetin Alfa
- Where
- Brazil
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Azidus Brasil
Acute Venous and Arterial Thrombotic and Thromboembolic Events, Healthy Volunteers
A Study to Learn About How Safe BAY3018250 is and What Happens to it in Healthy Japanese Men and Adult Participants Aged 18 to 55 Years
Researchers are looking for a better way to treat people who have acute venous and arterial thrombotic and thromboembolic events. These are severe medical problems due to blood clots forming in and blocking blood vessels.
- Trial name
- NCT06562985
- Testing
- BAY3018250 Dose 1, BAY3018250 Dose 2 infusion, BAY3018250 Dose 2 injection
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteer
A Study of DISC-3405 in Healthy Volunteers
This phase 1 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of DISC-3405 in adult male and female healthy volunteers.
- Trial name
- NCT06050915
- Testing
- DISC-3405
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Disc Medicine, Inc
Hepatitis C
A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)
This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts. Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II will enroll genotype 3 (GT3) HCV-infected…
- Trial name
- NCT01593735
- Testing
- MK-2748
- Volunteers
- 30 people
- Sponsor
- Merck Sharp & Dohme LLC
Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 (Integrin alpha-V/beta-8 Antagonist) in patients with SCCHN (Squamous…
- Conditions
- Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Ovarian Cancer, Gastric Cancer
- Trial name
- NCT04152018
- Testing
- PF-06940434, PF-06801591
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 85 people
- Sponsor
- Pfizer
Healthy
Study Evaluating Multiple Doses Of GSI-953 Within The Elderly Population
To assess the safety and tolerability of ascending, multiple, oral doses of GSI-953 in healthy elderly subjects.
- Trial name
- NCT00547560
- Testing
- GSI-953
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
Pharmacodynamic and Pharmacokinetic Study of 2 Different Dose Regimen of Clopidogrel in CYP2C19 Genotyped Healthy Subjects
Primary Objective: Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate (ADP)-induced platelet aggregation after administration of a standard dose regimen of clopidogrel (300 mg loading dose followed by…
- Trial name
- NCT01123824
- Testing
- CLOPIDOGREL
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hydronephrosis, Neurogenic Bladder
Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology
Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure [LPP] of…
- Trial name
- Alfahydro (NCT00576823)
- Testing
- Alfuzosin
- Where
- 12 sites in Bulgaria, Canada and 10 more
- Volunteers
- 25 people
- Sponsor
- Sanofi
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide in Healthy Male Volunteers
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and Tiotropium Bromide when given as fixed dose combination
- Trial name
- NCT02259959
- Testing
- Single rising doses of BI 1744 CL, solution for oral inhalation, Tiotropium, fixed dose, solution for oral inhalation
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
The main reason for this study is to see how the study drug interacts with the body. It will compare different doses of the study drug with a drug already in use.
- Trial name
- NCT03712280
- Testing
- MNK6106, Rifaximin
- Where
- 5 sites in United States, Puerto Rico
- Volunteers
- 50 people
- Sponsor
- Mallinckrodt
Impaired Glucose Tolerance, Insulin Resistance
Safety, Tolerability, PK, and PD of LIM-0705 in Subjects With Impaired Glucose Tolerance or Abnormal HOMA-IR
Preliminary research suggests that LIM-0705 improves insulin sensitivity with neutral effects on weight in obese and diabetic rodent models.
- Trial name
- NCT01364155
- Testing
- LIM-0705
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Limerick BioPharma
Hallux Valgus, Bunionectomy
Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
This is a Phase 2, randomized, double-blind, active-controlled, dose-escalation study evaluating the safety, pharmacokinetics, efficacy, and pharmacodynamics of ALX006, an extended-release bupivacaine formulation, administered as…
- Trial name
- NCT07574385
- Testing
- ALX006 (bupivacaine extended-release injection), Bupivacaine Hcl 0.25% Inj, Sciatic Nerve Block
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Rebel Medicine Inc
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