Clinical trials: Pharmacodynamics
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability, and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Participants
The primary purpose of the study is to evaluate the safety and tolerability of EA1080 following single and multiple ascending oral doses in healthy Caucasian and Japanese male participants.
- Trial name
- NCT04223960
- Testing
- EA1080
- Where
- United Kingdom
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- EA Pharma Co., Ltd.
Healthy
A Safety, Tolerability, PD and PK Study in Healthy Adults
The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects.
- Trial name
- NCT02211625
- Testing
- Open-label TRV734 125 mg, TRV734 blinded, Oxycodone IR 10 mg
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Trevena Inc.
Healthy
The Safety, Tolerability, PK, and PD of DWP213388 After SAD and MAD Administration in Healthy Adult Subjects
A Phase 1, First-in-human, Randomized, Double-blind, Placebo controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DWP213388 after Single and Multiple Ascending Oral Dose Administration in…
- Trial name
- NCT05607589
- Testing
- DWP213388
- Volunteers
- healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Sickle Cell Disease (SCD)
Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)
The purpose of the CSEG101A2202 study was to characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of SEG101/crizanlizumab and to evaluate the safety and efficacy of SEG101/crizanlizumab in sickle cell disease (SCD)…
- Trial name
- NCT03264989
- Testing
- crizanlizumab
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
Anticoagulant
Evaluation of the Pharmacodynamics of a Heparin With Its Biological Comparator, Subcutaneous Administration
Experimental Drug: Porcine sodium heparin, injectable solution - 5,000 IU/ 0.25 mL; Blau Farmacêutica S/A. Comparator Drug: Heparin Sodium Injection, USP, injectable solution - 5,000 IU/ 0.5 mL; Fresenius Kabi Lake Zurich.
- Trial name
- NCT05788913
- Testing
- Heparin
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Blau Farmaceutica S.A.
Safety Issues
Oral Remimazolam With and Without Alcohol in Healthy Female Subjects
A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects
- Trial name
- NCT04113343
- Testing
- Remimazolam, Alcohol
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Paion UK Ltd.
Alzheimer Disease
Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab
This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US).
- Trial name
- NCT00916617
- Testing
- bapineuzumab
- Where
- 16 sites in United States
- Volunteers
- 62 people
- Sponsor
- Pfizer
Renal Impairment
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 Tablet Dose in Men and Woman With Renal Impairment and in Healthy Subjects
To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to dosing, and age-, weight- and…
- Trial name
- NCT03235076
- Testing
- BAY1101042
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
Psoriasis
A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
This is a Phase Ib clinical study of multiple dose escalation of AK111 in subjects with moderate-to-severe plaque psoriasis
- Trial name
- NCT05504317
- Testing
- AK111
- Where
- 2 sites in China
- Volunteers
- 48 people
- Sponsor
- Akeso
Type 2 Diabetes
Open Label Safety & Pharmacodynamic Study 24Wk w/DIO-902 Combo w/Metformin & Atorvastatin in T2DM Patients
DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the ketoconazole molecule for the treatment of elevated blood glucose associated with type 2 diabetes mellitus.
- Trial name
- NCT00622089
- Testing
- DIO-902
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 150 people
- Sponsor
- DiObex
Healthy
Single Dose Pharmacodynamic and Pharmacokinetic Study of DG3173
In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and placebo control.
- Trial name
- NCT02217826
- Testing
- DG3173, Saline, Octreotide
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Aspireo Pharmaceuticals Limited
Type 1 Diabetes Mellitus
The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate glycemic control on insulin defined as HbA1c ≥…
- Trial name
- NCT02582840
- Testing
- Dapagliflozin 5mg, Dapagliflozin 10mg
- Where
- Japan
- Volunteers
- 42 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 2
Renal Impairment in Type 2 Diabetic Subjects
The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type 2 diabetic and healthy subjects with…
- Trial name
- NCT00554450
- Testing
- Dapagliflozin
- Where
- 4 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Chronic Weight Management
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight
This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection
- Trial name
- NCT07842640
- Testing
- ASC35 Injection B, for subcutaneous use, Tirzepatide
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Ascletis Pharma (China) Co., Limited
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 14332 CL Powder in Healthy Male Subjects
To investigate safety, tolerability and pharmacokinetics, and pharmacodynamics of BI 14332 CL
- Trial name
- NCT02211989
- Testing
- BI 14332 CL
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Contraception
To Investigate the Pharmacological Effects, Drug Blood Levels and Safety of an Intrauterine System Releasing the Study Drug BAY1007626 in Comparison to Mirena and Jaydess in Healthy Young Women Treated for 90 Days to Determine the Drug Dose for Further Development
Investigation of pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the…
- Trial name
- NCT02490774
- Testing
- BAY1007626, Jaydess, Mirena
- Where
- 7 sites in Germany, Netherlands and 1 more
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteers, Pharmacokinetics/Dynamics Study
A Short Term Pharmacokinetic, Pharmacodynamic and Tolerability Study to Compare AOP200704 vs. Esmolol
Pharmacokinetics, pharmacodynamics and tolerability of AOP200704 infusion is compared to that of Esmolol by measurement of plasma concentrations of AOP200704, esmolol and their metabolites, by assessing the effect of both drugs…
- Trial name
- NCT01313143
- Testing
- AOP200704, Esmolol hydrochloride, infusion
- Where
- Czechia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AOP Orphan Pharmaceuticals AG
Healthy Participants
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin and Furosemide in Healthy Participants
This study consists of 3 parts: Part A, Part B and Part C. This study will compare the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD4144 with placebo in healthy participants, in Part A and Part B.
- Trial name
- NCT06491550
- Testing
- AZD4144- Part A, AZD4144- Part B, Rosuvastatin and Furosemide- Part C
- Where
- 2 sites in United States
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Muscular Atrophy, Spinal
Investigate Safety, Tolerability, PK, PD and Efficacy of Risdiplam (RO7034067) in Infants With Type1 Spinal Muscular Atrophy
Open-label, multi-center clinical study is to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and efficacy of Risdiplam (RO7034067) in infants with Type 1 spinal muscular atrophy (SMA).
- Trial name
- FIREFISH (NCT02913482)
- Testing
- Risdiplam
- Where
- 32 sites in United States, Belgium and 14 more
- Volunteers
- 62 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers, Enteric Hyperoxaluria
Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects
The first stage of this study is a prospective, adaptive, Phase 1, first-in-human, randomized, controlled study evaluating safety, tolerability, and pharmacodynamics of NOV-001 in adult healthy volunteers.
- Trial name
- NCT04909723
- Testing
- NOV-001, NB1000S, NB2000P
- Where
- 20 sites in United States, Canada
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Novome Biotechnologies Inc