Clinical trials: Pharmacodynamics
Healthy
Single Rising Oral Doses of BI 1021958 in Healthy Chinese and Japanese Male Volunteers
Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after single rising doses (SRD) in healthy Asian male volunteers
- Trial name
- NCT01638598
- Testing
- Test drug
- Where
- South Korea
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Safety and Tolerability in Healthy Volunteers
A Single and Multiple Ascending Dose Study of ANX009 in Normal Healthy Volunteers (NHV)
The purpose of this study is to evaluate the safety, tolerability, pharmakokinetics and pharmacodynamics of single and repeated doses of ANX009
- Trial name
- NCT04535752
- Testing
- ANX009
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Annexon, Inc.
Anemia, Chronic Kidney Disease
Peginesatide for Anemia in Chronic Hemodialysis Patients
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of peginesatide in participants with chronic kidney disease (CKD) who are on hemodialysis.
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure
- Trial name
- NCT00228449
- Testing
- peginesatide
- Where
- 14 sites in United States
- Volunteers
- 165 people
- Sponsor
- Affymax
Diabetes Mellitus, Type 2
A Study of the Effect of Dulaglutide on the Action of Warfarin in Healthy Participants
Warfarin is a commonly used drug to prevent the blood from clotting. The purpose of this study is to determine if dulaglutide (LY2189265) affects how warfarin works.
- Trial name
- NCT01432938
- Testing
- dulaglutide, Warfarin
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Duchenne Muscular Dystrophy
Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy
To evaluate the long-term safety and tolerability of ACE-031 administration in subjects with Duchenne muscular dystrophy (DMD) who participated in Study A031-03. [Note: This study was terminated based on preliminary safety data.
- Trial name
- NCT01239758
- Testing
- ACE-031 (Extension of cohort 1 from core study, A031-03), ACE-031 (Extension of cohort 2 from core study, A031-03), ACE-031 (Extension of cohort 3 from core study, A031-03)
- Where
- 4 sites in Canada
- Volunteers
- 11 people
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Graft Failure
Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After HSCT.
This study is designed as an open-label, single arm, proof of concept study in order to determine the appropriate emapalumab dosing regimen neutralizing IFNγ in patients at risk of GF.
- Trial name
- NCT04731298
- Testing
- Emapalumab
- Where
- 5 sites in Australia, Canada and 1 more
- Volunteers
- 2 people
- Sponsor
- Swedish Orphan Biovitrum
Lupus Erythematosus, Systemic
Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT00714116
- Testing
- SBI-087
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Pfizer
Diabetes, Diabetes Mellitus, Type 2
A Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the…
- Trial name
- NCT02964104
- Testing
- Insulin icodec, insulin degludec
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Novo Nordisk A/S
Healthy
A Study of Macitentan, in Healthy Japanese Male Participants
The main purpose of this study is to evaluate the safety and tolerability after multiple-dose administrations of macitentan with titration regimen starting from Dose 1 once daily (qd) up to Dose 2 qd in Japanese healthy adult…
- Trial name
- NCT04500808
- Testing
- Macitentan Dose 1, Macitentan Dose 2, Macitentan Dose 3
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Atrophy, Geographic
Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
The purpose of this study is to determine the safety and efficacy of GSK933776 in the treatment of geographic atrophy secondary to age-related macular degeneration.
- Trial name
- NCT01342926
- Testing
- GSK933776
- Where
- 41 sites in United States, Canada
- Volunteers
- 191 people
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People
This study will look at two different oral formulations and compare them. The medicine in the study is called NDec and it is a combination of two medicines (decitabine and tetrahydrouridine).
- Trial name
- NCT06291285
- Testing
- Decitabine-THU
- Where
- 2 sites in United States, Germany
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Ulcerative Colitis
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of EQ504 in Single and Multiple Ascending Doses in Healthy Volunteers
This is a Phase 1, first in human, three-part randomized, double-blind, placebo-controlled dose escalation trial to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of EQ504 following single…
- Trial name
- NCT07869225
- Testing
- EQ504
- Where
- Australia
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Equillium
Prostate Cancer
Sulforadex in Healthy Human Males MAD
To determine the safety and tolerability of multiple doses of Sulforadex® in healthy male volunteers over 7 days with qd or bid dosing
- Trial name
- NCT02055716
- Testing
- Sulforadex, alpha-cyclodextrin
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Evgen Pharma
Solid Tumors
Study of NGR-hTNF Administered at High Doses in Patient With Advanced or Metastatic Solid Tumour
The main objective of the trial is to document the safety and antivascular effect of escalating doses of NGR-hTNF, from 60 mcg/sqm to 325 mcg/sqm, in patients affected by advanced or metastatic solid tumors not amenable of…
- Trial name
- NCT00878111
- Testing
- NGR-hTNF
- Where
- Italy
- Volunteers
- 48 people
- Sponsor
- AGC Biologics S.p.A.
Atopic Dermatitis
Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis
The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).
- Trial name
- NCT01548404
- Testing
- Dupilumab
- Where
- 21 sites in Czechia, France and 3 more
- Volunteers
- 109 people
- Sponsor
- Regeneron Pharmaceuticals
Hepatitis C
A First in Human Study of AL-611 in Healthy Volunteers and Patients With Hepatitis C Virus Infection
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally administered AL-611 in healthy volunteers (HV; Parts 1-2)…
- Trial name
- NCT03253471
- Testing
- AL-611
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Myotonic Dystrophy Type 1 (DM1)
A Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1)
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VX-670 at different single and multiple doses in participants with DM1.
- Trial name
- Galileo (NCT06185764)
- Testing
- VX-670
- Where
- 26 sites in United States, Australia and 8 more
- Volunteers
- 47 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Gastric Cancer, Gastroesophageal Junction Cancer
Study for AZD4360 in Participants With Advanced Solid Tumours
The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for…
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma
- Trial name
- NCT06921928
- Testing
- AZD4360
- Where
- 14 sites in United States, China and 3 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD).
- Trial name
- NCT03118765
- Testing
- GSP304 (tiotropium bromide) Inhalation Solution, Spiriva® Respimat® inhalation spray
- Where
- 25 sites in United States
- Volunteers
- 155 people
- Sponsor
- Glenmark Specialty S.A.
Healthy Subjects
A Clinical Study of AK139 in Healthy Subjects
This is a phase I clinical study on dose escalation evaluating the safety, tolerability, PK and PD of a single dose of AK139 administered subcutaneously in healthy subjects.
- Trial name
- NCT06947109
- Testing
- AK111
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Akeso
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